Therapeutic Index

Beximco Pharmaceuticals Ltd.

H E R A P E U T I C

N D E X

Published in March 2004 Copyright 2004 all rights reserved Compiled and Published by Medical Department Beximco Pharmaceuticals Ltd. Design and Computer Graphics by DTP, Medical Department Printed by Shuktara Printers, Gazipur
PTG-235/02-04/5000 SHUK

O UR M ISSION

OUR MISSION ISSION

ach of our activities must benefit and add value to the common wealth of our society. We firmly believe that, in the final analysis we are accountable to each of the constituents with whom we interact; namely: our employees, our customers, our business associates, our fellow citizens and our shareholders. History Key milestones 1976 1980 Registration of the company Started manufacturing and marketing of licensee products of Bayer AG of Germany and Upjohn Inc. of USA Launching its own products Listing in the Dhaka Stock Exchange (DSE) as a Public Limited Company (PLC) Commissioning of Basic Chemical unit Started export operation with Active Pharmaceutical Ingredients (APIs) First export market operation with Finished Pharmaceutical Products

1983 1985 1990 1992 1993

1994-95 The first pharmaceutical company in the country to receive National Export Trophy (Gold) 1996 Introduction of Sustained Release dosage form in the market
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M I S S I O N

1997 1998 1999 2000 2001

Commissioning of Metered Dose Inhaler (MDI) plant and introduction of Suppository dosage form Introduction of Metered Dose Nasal Spray UNICEF approval of BPL as an enlisted supplier Contract manufacturing agreement of Metered Dose Inhaler (MDI) with Glaxo SmithKline Introduction of small volume parenteral products (Injectables) and Establishment of AnalgesicAntiinflammatory bulk-drug plant The first Bangladeshi company to supply pharmaceuticals to Raffles Hospital of Singapore

1998-99 Received National Export Trophy (Gold) 1999-00 Received National Export Trophy (Gold)

2002

The Profile Corporate Headquarters : 17 Dhanmondi R/A, Road No. 2, Dhaka 1205, Bangladesh Operational Headquarter : 19 Dhanmondi R/A, Road No. 7, Dhaka 1205, Bangladesh Factory : Auspara, Tongi, Gazipur Business Lines : Manufacturing and marketing of pharmaceutical finished products and Active Pharmaceutical Ingredients (APIs) Overseas Offices and Associates : UK, USA, Pakistan, Nepal, Myanmar, Singapore, Kenya, Yemen. Export Outlets : Bhutan, Georgia, Germany, Hong Kong, Iran, Iraq, Kenya, Malaysia, Myanmar, Nepal, Pakistan, Russia, Singapore, South Korea, Taiwan, Thailand, Ukraine, Vietnam and Yemen.
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M I S S I O N

International Marketing In BPL we are proactive in our approach to aggressively search for new avenues in the international market place: Beximco Pharma is the pioneer in entering the CIS countries. BPL is the first pharmaceutical company in Bangladesh to receive National Export Trophy Gold in 1998. In Pakistan, BPL took proactive measures in launching its products with Multimedia CD-ROM replacing the age-old printed promotional materials. In Myanmar, BPL further consolidated its position by donating Medical Information Kiosks to the Myanmar Medical Association. Beximco Pharma is the only Bangladeshi pharmaceutical company operating in Singapore market- one of the most stringent and regulated markets in Asia. Beximco Pharma was the first company from Bangladesh to enter the African Market. We are delighted and proud of our pioneering achievements. More than that, we have probably fulfilled a national aspiration of turning an import dependent country into an exporter of quality medicines. Despite the fact that there is no incentive for pharmaceutical export in Bangladesh, till today, we have not deviated from our proactive and pioneering role in international marketing. Our journey that began amidst many obstacles has now expanded to nineteen countries. In 2002, BPLs major emphasis in international marketing was to consolidate and grow in all its existing overseas markets by ensuring
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M I S S I O N

sustainable competitive advantage over our competitors and competitive brands. In 2002, we were awarded a tender order for our Neoceptin R for the whole years consumption of Raffles Hospital- the most prestigious hospital in Singapore. We have also supplied our product in KK Womens and Childrens Hospital in Singapore. In order to expand our product portfolio in Myanmar, we have launched liquid/bottle items by organizing a huge scientific seminar. We have supplied our products to Shaukat Khanum Memorial Cancer Hospital & Research Center and Aga Khan University Hospital- the two renowned institutions in Pakistan. In Kenya, we have started supplying to Mission for Essential Drugs and Supplies (MEDS)- the largest institution and Kenyatta Hospital -the largest hospital in Kenya. While consolidating in all our existing overseas markets, we are determined to continue deploying our efforts and resources to develop new overseas markets in Asia, Africa, and Europe. As a part of our ongoing new market exploration activities, in 2002 we participated in all major exhibitions held in Russia, Ukraine, Afghanistan and Nepal. For evaluating business opportunities in new overseas markets, we conducted market research in various markets in Asia and Europe. The Leading Health Care Company in Bangladesh Beximco Pharmaceuticals Ltd. is a member of the Beximco Group- the largest private sector business conglomerate of Bangladesh, comprising 8 divisions and over 22000 employees. BPL, the largest pharmaceutical as well as bulk drug manufacturer of
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M I S S I O N

Bangladesh started its journey back in 1980 with manufacturing and marketing of licensee products of Bayer AG, Germany and Upjohn Inc. of USA. BPL launched 6 of its own products in 1983. We strongly believe in high quality and cost-effective medicine. We are proud to become first enlisted supplier to international bodies like UNICEF, UNDP, WHO and ICDDR,B. The National Recognition for Excellence In addition to local market, BPLs export activities are there in nineteen countries of three continents- Asia, Europe and Africa. For its outstanding export performance, BPL received Bangladeshs highest award for export, the National Export Trophy, Gold in 1994-95. BPL is the first pharmaceutical company in Bangladesh to receive such an award. BPL was also awarded National Export Trophy Gold for two consecutive years 1998-1999 & 1999-2000. BPL is the record three times winner of this national highest recognition for export. Committed to Serve BPLs commitment is to always offer the best, both in quality and services to its customers. Quality is the measure of excellence in the field of pharmaceutical products. BPL feels that it has an incalculable social liability of providing safe, efficacious and highest quality drugs. Equipped with the latest & the most advanced state-of-the-art technologies BPL team is committed to serve its customers. Through the highest quality drugs BPL has succeeded in gaining the confidence & trust of doctors & patients all over the country.

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M I S S I O N

BPL- A Company with Vision for Tomorrow BPL has transformed its activities, culture, style and philosophy to meet the demands of the new millennium. Business diversifications that are strategically important for a sustained growth are results of its vision of the future. Several new bulk drug facilities are being developed to backward integrate their high volume products. A USFDA standard multi-million dollar pharmaceutical formulation plant is nearing completion. This would be one of the most modern plants in this region. Our Differential Edge World class manufacturing facilities Highest cGMP standards Outstanding product quality Sophisticated formulation technology Diversified and hightech dosage forms & products Significant investment in R&D Excellent customer services Responsible care for the environment Commitment to the people & the society

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CONTENTS

IN

BRAND N AME

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Aeronid Inhaler Alendon Tablet Alphin DS Tablet Amdocal Tablet Anustat Ointment

G ENERIC NAME 1 6 9 11 14

Budesonide BP Alendronate Sodium BP Albendazole USP Amlodipine Besylate INN Cinchocaine Hydrochloride BP, Hydrocortisone BP, Neomycin Sulphate USP and Esculin Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP Arbit Tablet Irbesartan INN Aristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BP Aristofol-Fe Tablet Ferrous Fumarate BP and Folic Acid USP Aristoplex Syrup Vitamin B Complex Aristovit-B Tablet Vitamin B Complex Aristovit-M Tablet Multivitamin and Mineral Aristovit-X Tablet Antioxidant, Vitamin, and Mineral Arixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INN Ascobex Tablet Ascorbic Acid USP Atova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BP Avastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INN Avifix Tablet Nelfinavir Mesylate INN Avilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USP Axodin Tablet Fexofenadine Hydrochloride INN Azithrocin Capsule Azithromycin USP /Tablet/Suspension Azmasol Inhaler Salbutamol BP Bexidal Tablet Mebhydrolin Napadisylate BPC Bexitrol-F Inhaler Fluticasone Propionate BP and Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN

16 18 20 22 24 26 28 29 31 33 36 39 41 46 48 51 53 58 64 68 70 74 77 80 81 84

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C O N T E N T S

I N

B R A N D

N A M E

B RAND NAME Bextrum Tablet Bronkolax Tablet /Syrup Cardopril Tablet Carocet Tablet Carofol-Z Capsule Cephalen Capsule /Suspension Cerivin Tablet Clobex Capsule/Syrup Cosmotrin Cream Cox B Capsule Curin Tablet Decacycline Capsule Decomit Inhaler Decomit Nasal Spray Deflux Tablet /Suspension /Paediatric Drops Dextromethorphan Syrup Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Diavix Tablet Dilapress Tablet Ecotrim Cream Efol-ER Capsule

G ENERIC NAME High potency Multivitamin and Multimineral Salbutamol Sulphate BP Captopril USP Beta Carotene, Ascorbic Acid USP and dl-alpha-Tocopheryl Acetate Carbonyl Iron INN, Folic Acid BP and Zinc Sulphate Monohydrate USP Cefalexin BP Vinpocetine INN Cloxacillin Sodium BP Tretinoin USP Celecoxib INN Levocetrizine Dihydrochloride INN Tetracycline Hydrochloride BP Beclomethasone Dipropionate BP Beclomethasone Dipropionate BP Domperidone Maleate BP/ Domperidone BP Dextromethorphan Hydrobromide BP Glipizide BP Pioglitazone Hydrochloride INN Gliclazide BP Glimepiride INN Lamivudine INN and Zidovudine USP Carvedilol BP Econazole Nitrate BP and Triamcinolone Acetonide BP Ferrous Sulphate BP, Folic Acid USP and Zinc Sulphate Monohydrate USP Enalapril Maleate USP Carbamazepine BP Zaleplon INN xvi 87 89 91 94 96 98 101 103 105 107 112 114 116 119 121

123 124 130 133 136 140 144 147 149

Enaril Tablet Epilep Tablet Eplon Capsule

152 155 158

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Etrocin Tablet /Suspension Evo Tablet Fertil Tablet Fibril Capsule Filmet Tablet /Suspension Flatameal-DS Tablet /Suspension Flubex Capsule/Syrup Formula E Tablet Frelax Powder Frenxit Tablet Fungistin Suspension Furasep Cream Fusidic Plus Ointment Gastalfet Tablet Gentosep Cream Hefolin SR Capsule Inarzin Tablet Informet LA Tablet Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Ipramid Inhaler Isofloxin Tablet Keolax Tablet Lactameal Tablet /Suspension Larnox LA Tablet Lucidol Capsule Megadox Capsule

GENERIC N AME Erythromycin USP Levofloxacin Hemihydrate INN Clomiphene Citrate USP Gemfibrozil USP Metronidazole BP/Metronidazole Benzoate BP Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and Simethicone USP Flucloxacillin Sodium BP Vitamin E USP Polyethylene Glycol 3350 USP NF Flupentixol Dihydrochloride BP and Melitracen Hydrochloride INN Nystatin BP Nitrofurazone USP Sodium Fusidate BP and Hydrocortisone Acetate BP Sucralfate USP Gentamicin Sulphate BP Ferrous Sulphate BP and Folic Acid BP Cinnarizine BP Metformin Hydrochloride BP Cephradine BP 162 166 168 171 173 175

176 178 181 184 186 188 189 191 193 194 196 198 201

Cephradine USP Ipratropium Bromide BP Pefloxacin Mesilate BP Clobazam BP Aluminium Hydroxide Gel USP and Magnesium Hydroxide BP Aminophylline BP Tramadol Hydrochloride BP Doxycycline Hydrochloride BP xvii

204 207 210 213 215 216 219 222

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Megatrim DS Tablet Megatrim Suspension Melphin Tablet /Suspension Modipran Capsule Momento Tablet/Syrup Monate Tablet Monocast Tablet Napa Tablet/Syrup /Suppository /Paediatric drops Nazolin Nasal Spray Nebactil Suspension Neo Kit Neocard Tablet Neoceptin R Tablet /Syrup Neodrop Paediatric Drops Neofloxin Tablet Neopril Tablet Neosten Cream Neosten VT Nightus Tablet Noscab Cream Nuprafen Tablet Odrel Tablet Omastin Capsule /Suspension Opton Tablet Pacet Tablet Pedeamin Syrup

G ENERIC NAME Trimethoprim BP and Sulfamethoxazole BP Trimethoprim BP and Sulfamethoxazole BP Pyrantel Pamoate USP Fluoxetine Hydrochloride BP Desloratadine INN Isosorbide Mononitrate BP Montelucast Sodium INN Paracetamol BP 225 225 229 231 234 237 239 244

Oxymetazoline Hydrochloride USP Nalidixic Acid BP Clarithromycin USP, Omeprazole BP and Metronidazole BP Diltiazem Hydrochloride USP Ranitidine Hydrochloride USP Simethicone USP Ciprofloxacin Hydrochloride USP Lisinopril USP Clotrimazole BP Clotrimazole BP Bromazepam BP Permethrin INN Naproxen USP Clopidogrel Bisulfate INN Fluconazole INN Esomeprazole Magnesium Trihydrate INN Amiodarone Hydrochloride BP Diphenhydramine Hydrochloride BP

246 248 250 252 254 256 258 263 269 271 273 275 277 280 282 286 289 292

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I N

B R A N D

N A M E

BRAND NAME Pregvit Capsule

G ENERIC NAME Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP, Pyridoxine Hydrochloride USP & Ascorbic Acid USP Repaglinide USP Loratadine INN Ramipril BP Omeprazole BP Losartan Potassium INN Finasteride USP Lansoprazole USP Rofecoxib INN Finasteride USP Glucosamine Hydrochloride USP Tizanidine Hydrochloride INN Spironolactone BP and Frusemide BP lbuprofen BP Clarithromycin USP Mebeverine Hydrochloride BP Clozapine BP Lactulose Solution BP Sibutramine Hydrochloride Monohydrate INN Hyoscine Butylbromide BP Sparfloxacin INN Bromhexine Hydrochloride BP Tamoxifen Citrate BP Drotaverine Hydrochloride INN Terbinafine Hydrochloride INN Ketotifen Fumarate BP Cefixime Trithydrate USP Lamivudine INN, Zidovudine USP and Nevirapine INN 294

Premil Tablet Pretin Tablet Primace Capsule Proceptin-20 Capsule Prosan Tablet Prosfin Tablet Protolan Capsule Recox Tablet Recur Tablet Reflon Tablet Relentus Tablet Resitone Tablet Reumafen Tablet /Suspension Rolacin Tablet Rostil Tablet Sensipin Tablet Serelose Solution Sibulin Capsule Spanil Tablet Sparlin Tablet Spulyt Tablet/Syrup Tamona Tablet Taverin Tablet Terbex Cream/Tablet Tofen Tablet/Syrup Triocim Capsule /Suspension Triovix Tablet

296 300 302 305 308 310 313 316 319 321 323 325 327 330 333 335 339 341 344 345 347 349 353 355 357 359 361

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I N

B R A N D

N A M E

BRAND NAME Tripec Syrup

GENERIC NAME Guaifenesin BP, Pseudoephedrine Hydrochloride BP and Triprolidine Hydrochloride BP Amoxicillin Trihydrate BP 364

Tycil Capsule /Suspension /Paediatric Drops Tycil DS Suspension Tynisol Drops Ultrafen Tablet /Suppository/Gel Uricon Tablet Uroflo Capsule Valcap Capsule V-Cox Tablet Xynofen-100 SR Capsule Yamadin Tablet Zedex-DS Syrup Zocil Tablet Zukast Tablet Zymet Tablet

366

Amoxicillin Trihydrate BP Multivitamin Diclofenac Sodium BP/Diclofenac Diethylamine BP Oxybutynin Chloride USP Tamsulosin Hydrochloride INN Valsartan INN Valdecoxib INN Ketoprofen BP Famotidine USP Zinc Sulphate Monohydrate USP Cilostazol INN Zafirlukast INN Pancreatin BP

366 369 371 374 377 379 382 386 389 391 393 395 401

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CONTENTS

IN

THERAPEUTIC GROUP

C O N T E N T S

I N

T H E R A P E U T I C

G R O U P

BRAND NAME Analgesic & Antipyretic Napa Tablet/Syrup /Suppository /Paediatric drops Anthelmintic Alphin DS Tablet Melphin Tablet/Suspension Anti-acne preparation Cosmotrin Cream

G ENERIC NAME Paracetamol 244

Albendazole Pyrantel Pamoate

9 229

Tretinoin

105

Anti-osteoarthritic preparation Reflon Tablet Glucosamine Hydrochloride Anti-asthma preparation Aeronid Inhaler Azmasol Inhaler Bexitrol-F Inhaler Bexitrol Inhaler Bronkolax Tablet/Syrup Decomit Nasal Spray Ipramid Inhaler Larnox LA Tablet Anti-cancer preparation Tamona Tablet Antidepressant Apresin Tablet

321

Budesonide Salbutamol Fluticasone Propionate and Salmeterol Xinafoate Salmeterol Xinafoate Salbutamol Sulphate Beclomethasone Dipropionate Ipratropium Bromide Aminophylline

1 77 81 84 89 119 207 216

Tamoxifen Citrate

349

Fluphenazine Hydrochloride and Nortriptyline Hydrochloride

16

xxiii

C O N T E N T S

I N

T H E R A P E U T I C

G R O U P

BRAND NAME Frenxit Tablet

G ENERIC NAME Flupentixol Dihydrochloride and Melitracen Hydrochloride Fluoxetine Hydrochloride Clozapine 184

Modipran Capsule Sensipin Tablet Antidiabetic preparation Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Informet LA Tablet Premil Tablet Anti-emetic preparation Deflux Tablet/Suspension /Paediatric Drops Anti-epileptic preparation Epilep Tablet

231 335

Glipizide Pioglitazone Hydrochloride Gliclazide Glimepiride Metformin Hydrochloride Repaglinide

124 130 133 136 198 296

Domperidone Maleate

121

Carbamazepine

155

Anti-haemorrhoidal preparation Anustat Ointment Cinchocaine Hydrochloride, Hydrocortisone, Neomycin Sulphate and Esculin Anti-histamine preparation Atrizin Tablet/Syrup Axodin Tablet Bexidal Tablet Curin Tablet Momento Tablet/Syrup Pedeamin Syrup Pretin Tablet

14

Cetirizine Hydrochloride Fexofenadine Hydrochloide Mebhydrolin Napadisylate Levocetrizine Dihydrochloride Desloratadine Diphenhydramine Hydrochloride Loratadine

46 70 80 112 234 292 300

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C O N T E N T S

I N

T H E R A P E U T I C

G R O U P

B RAND NAME Anti-HIV preparation Avifanz Tablet Avifix Tablet Avilam Tablet Diavix Tablet Triovix Tablet

GENERIC NAME

Efavirenz Nelfinavir Mesylate Lamivudine Lamivudine and Zidovudine Lamivudine, Zidovudine and Nevirapine

53 58 64 140 361

Anti-microbial preparation Antibacterials Arixon IV/IM Injection Arlin Tablet/Suspension Azithrocin Capsule/Tablet /Suspension Cephalen Capsule /Suspension Clobex Capsule/Syrup Decacycline Capsule Etrocin Tablet/Suspension Evo Tablet Filmet Tablet/Suspension Flubex Capsule/Syrup Furasep Cream Fusidic Plus Ointment Gentosep Cream Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Isofloxin Tablet Megadox Capsule 33 36 74 98 103 114 162 166 173 176 188 189 193 201

Ceftriaxone Sodium Linezolid Azithromycin Cephalexin Cloxacillin Sodium Tetracycline Hydrochloride Erythromycin Levofloxacin Hemihydrate Metronidazole/ Metronidazole Benzoate Flucloxacillin Sodium Nitrofurazone Sodium Fusidate and Hydrocortisone Acetate Gentamicin Sulphate Cephradine

Cephradine Pefloxacin Mesilate Doxycycline Hydrochloride

204 210 222

xxv

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Aeronid Inhaler Alendon Tablet Alphin DS Tablet Amdocal Tablet Anustat Ointment

G ENERIC NAME 1 6 9 11 14

Budesonide BP Alendronate Sodium BP Albendazole USP Amlodipine Besylate INN Cinchocaine Hydrochloride BP, Hydrocortisone BP, Neomycin Sulphate USP and Esculin Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP Arbit Tablet Irbesartan INN Aristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BP Aristofol-Fe Tablet Ferrous Fumarate BP and Folic Acid USP Aristoplex Syrup Vitamin B Complex Aristovit-B Tablet Vitamin B Complex Aristovit-M Tablet Multivitamin and Mineral Aristovit-X Tablet Antioxidant, Vitamin, and Mineral Arixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INN Ascobex Tablet Ascorbic Acid USP Atova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BP Avastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INN Avifix Tablet Nelfinavir Mesylate INN Avilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USP Axodin Tablet Fexofenadine Hydrochloride INN Azithrocin Capsule Azithromycin USP /Tablet/Suspension Azmasol Inhaler Salbutamol BP Bexidal Tablet Mebhydrolin Napadisylate BPC Bexitrol-F Inhaler Fluticasone Propionate BP and Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN

16 18 20 22 24 26 28 29 31 33 36 39 41 46 48 51 53 58 64 68 70 74 77 80 81 84

xv

C O N T E N T S

I N

B R A N D

N A M E

B RAND NAME Bextrum Tablet Bronkolax Tablet /Syrup Cardopril Tablet Carocet Tablet Carofol-Z Capsule Cephalen Capsule /Suspension Cerivin Tablet Clobex Capsule/Syrup Cosmotrin Cream Cox B Capsule Curin Tablet Decacycline Capsule Decomit Inhaler Decomit Nasal Spray Deflux Tablet /Suspension /Paediatric Drops Dextromethorphan Syrup Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Diavix Tablet Dilapress Tablet Ecotrim Cream Efol-ER Capsule

G ENERIC NAME High potency Multivitamin and Multimineral Salbutamol Sulphate BP Captopril USP Beta Carotene, Ascorbic Acid USP and dl-alpha-Tocopheryl Acetate Carbonyl Iron INN, Folic Acid BP and Zinc Sulphate Monohydrate USP Cefalexin BP Vinpocetine INN Cloxacillin Sodium BP Tretinoin USP Celecoxib INN Levocetrizine Dihydrochloride INN Tetracycline Hydrochloride BP Beclomethasone Dipropionate BP Beclomethasone Dipropionate BP Domperidone Maleate BP/ Domperidone BP Dextromethorphan Hydrobromide BP Glipizide BP Pioglitazone Hydrochloride INN Gliclazide BP Glimepiride INN Lamivudine INN and Zidovudine USP Carvedilol BP Econazole Nitrate BP and Triamcinolone Acetonide BP Ferrous Sulphate BP, Folic Acid USP and Zinc Sulphate Monohydrate USP Enalapril Maleate USP Carbamazepine BP Zaleplon INN xvi 87 89 91 94 96 98 101 103 105 107 112 114 116 119 121

123 124 130 133 136 140 144 147 149

Enaril Tablet Epilep Tablet Eplon Capsule

152 155 158

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Etrocin Tablet /Suspension Evo Tablet Fertil Tablet Fibril Capsule Filmet Tablet /Suspension Flatameal-DS Tablet /Suspension Flubex Capsule/Syrup Formula E Tablet Frelax Powder Frenxit Tablet Fungistin Suspension Furasep Cream Fusidic Plus Ointment Gastalfet Tablet Gentosep Cream Hefolin SR Capsule Inarzin Tablet Informet LA Tablet Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Ipramid Inhaler Isofloxin Tablet Keolax Tablet Lactameal Tablet /Suspension Larnox LA Tablet Lucidol Capsule Megadox Capsule

G ENERIC NAME Erythromycin USP Levofloxacin Hemihydrate INN Clomiphene Citrate USP Gemfibrozil USP Metronidazole BP/Metronidazole Benzoate BP Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and Simethicone USP Flucloxacillin Sodium BP Vitamin E USP Polyethylene Glycol 3350 USP NF Flupentixol Dihydrochloride BP and Melitracen Hydrochloride INN Nystatin BP Nitrofurazone USP Sodium Fusidate BP and Hydrocortisone Acetate BP Sucralfate USP Gentamicin Sulphate BP Ferrous Sulphate BP and Folic Acid BP Cinnarizine BP Metformin Hydrochloride BP Cephradine BP 162 166 168 171 173 175

176 178 181 184 186 188 189 191 193 194 196 198 201

Cephradine USP Ipratropium Bromide BP Pefloxacin Mesilate BP Clobazam BP Aluminium Hydroxide Gel USP and Magnesium Hydroxide BP Aminophylline BP Tramadol Hydrochloride BP Doxycycline Hydrochloride BP xvii

204 207 210 213 215 216 219 222

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Megatrim DS Tablet Megatrim Suspension Melphin Tablet /Suspension Modipran Capsule Momento Tablet/Syrup Monate Tablet Monocast Tablet Napa Tablet/Syrup /Suppository /Paediatric drops Nazolin Nasal Spray Nebactil Suspension Neo Kit Neocard Tablet Neoceptin R Tablet /Syrup Neodrop Paediatric Drops Neofloxin Tablet Neopril Tablet Neosten Cream Neosten VT Nightus Tablet Noscab Cream Nuprafen Tablet Odrel Tablet Omastin Capsule /Suspension Opton Tablet Pacet Tablet Pedeamin Syrup

G ENERIC NAME Trimethoprim BP and Sulfamethoxazole BP Trimethoprim BP and Sulfamethoxazole BP Pyrantel Pamoate USP Fluoxetine Hydrochloride BP Desloratadine INN Isosorbide Mononitrate BP Montelucast Sodium INN Paracetamol BP 225 225 229 231 234 237 239 244

Oxymetazoline Hydrochloride USP Nalidixic Acid BP Clarithromycin USP, Omeprazole BP and Metronidazole BP Diltiazem Hydrochloride USP Ranitidine Hydrochloride USP Simethicone USP Ciprofloxacin Hydrochloride USP Lisinopril USP Clotrimazole BP Clotrimazole BP Bromazepam BP Permethrin INN Naproxen USP Clopidogrel Bisulfate INN Fluconazole INN Esomeprazole Magnesium Trihydrate INN Amiodarone Hydrochloride BP Diphenhydramine Hydrochloride BP

246 248 250 252 254 256 258 263 269 271 273 275 277 280 282 286 289 292

xviii

C O N T E N T S

I N

T H E R A P E U T I C

G R O U P

BRAND NAME Anti-microbial preparation Megatrim DS Tablet

G ENERIC NAME

Trimethoprim and Sulfamethoxazole Megatrim Suspension Trimethoprim and Sulfamethoxazole Nebactil Suspension Nalidixic Acid Neo Kit Clarithromycin, Omeprazole and Metronidazole Neofloxin Tablet Ciprofloxacin Hydrochloride Rolacin Tablet Clarithromycin Sparlin Tablet Sparfloxacin Triocim Capsule/Suspension Cefixime Trihydrate Tycil Capsule/Suspension Amoxicillin Trihydrate /Paediatric Drops Tycil DS Suspension Amoxicillin Trihydrate Antifungals Ecotrim Cream Fungistin Suspension Neosten Cream Neosten VT Omastin Capsules /Suspension Terbex Cream/Tablet Antidermatophytes Noscab Cream Anti-migraine preparation Avidro Tablet Anti-obesity preparation Sibulin Capsule

225 225 248 250 258 330 345 359 366 366

Econazole Nitrate and Triamcinolone Acetonide Nystatin Clotrimazole Clotrimazole Fluconazole Terbinafine Hydrochloride

147 186 269 271 282 355

Permethrin

275

Pizotifen Malate

51

Sibutramine Hydrochloride

341

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C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Pregvit Capsule

GENERIC N AME Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP, Pyridoxine Hydrochloride USP & Ascorbic Acid USP Repaglinide USP Loratadine INN Ramipril BP Omeprazole BP Losartan Potassium INN Finasteride USP Lansoprazole USP Rofecoxib INN Finasteride USP Glucosamine Hydrochloride USP Tizanidine Hydrochloride INN Spironolactone BP and Frusemide BP lbuprofen BP Clarithromycin USP Mebeverine Hydrochloride BP Clozapine BP Lactulose Solution BP Sibutramine Hydrochloride Monohydrate INN Hyoscine Butylbromide BP Sparfloxacin INN Bromhexine Hydrochloride BP Tamoxifen Citrate BP Drotaverine Hydrochloride INN Terbinafine Hydrochloride INN Ketotifen Fumarate BP Cefixime Trithydrate USP Lamivudine INN, Zidovudine USP and Nevirapine INN 294

Premil Tablet Pretin Tablet Primace Capsule Proceptin-20 Capsule Prosan Tablet Prosfin Tablet Protolan Capsule Recox Tablet Recur Tablet Reflon Tablet Relentus Tablet Resitone Tablet Reumafen Tablet /Suspension Rolacin Tablet Rostil Tablet Sensipin Tablet Serelose Solution Sibulin Capsule Spanil Tablet Sparlin Tablet Spulyt Tablet/Syrup Tamona Tablet Taverin Tablet Terbex Cream/Tablet Tofen Tablet/Syrup Triocim Capsule /Suspension Triovix Tablet

296 300 302 305 308 310 313 316 319 321 323 325 327 330 333 335 339 341 344 345 347 349 353 355 357 359 361

xix

C O N T E N T S

I N

T H E R A P E U T I C

G R O U P

BRAND NAME Antioxidant Carocet Tablet

G ENERIC NAME

Beta Carotene, Ascorbic Acid and dl-alpha-Tocopheryl Acetate

94

Anti-platelet aggregation preparation Odrel Tablet Clopidogrel Bisulphate Anti-resorptive preparation Alendon Tablet Alendronate Sodium Anti-spasmodic Rostil Tablet Spanil Tablet Taverin Tablet Uricon Tablet Antitussive Dextromethorphan Syrup Spulyt Tablet/Syrup Tripec Syrup

280

Mebeverine Hydrochloride Hyoscine Butylbromide Drotaverine Hydrochloride Oxybutynin Choloride

333 344 353 374

Dextromethorphan Hydrobromide Bromhexine Hydrochloride Guaifenesin, Pseudoephedrine & Triprolidine

123 347 364

Anxiolytics preparation Eplon Capsule Keolax Tablet Nightus Tablet Asthma Prophylactic Monocast Tablet Tofen Tablet/Syrup Zukast Tablet

Zaleplon Clobazam Bromazepam

158 213 273

Montelukast Sodium Ketotifen Fumarate Zafirlukast

239 357 395

Cardiovascular preparation Amdocal Tablet Amlodipine Besylate Arbit Tablet Irbesartan Cardopril Tablet Captopril xxvii

11 18 91

C O N T E N T S

I N

B R A N D

N A M E

BRAND NAME Tripec Syrup

G ENERIC NAME Guaifenesin BP, Pseudoephedrine Hydrochloride BP and Triprolidine Hydrochloride BP Amoxicillin Trihydrate BP 364

Tycil Capsule /Suspension /Paediatric Drops Tycil DS Suspension Tynisol Drops Ultrafen Tablet /Suppository/Gel Uricon Tablet Uroflo Capsule Valcap Capsule V-Cox Tablet Xynofen-100 SR Capsule Yamadin Tablet Zedex-DS Syrup Zocil Tablet Zukast Tablet Zymet Tablet

366

Amoxicillin Trihydrate BP Multivitamin Diclofenac Sodium BP/Diclofenac Diethylamine BP Oxybutynin Chloride USP Tamsulosin Hydrochloride INN Valsartan INN Valdecoxib INN Ketoprofen BP Famotidine USP Zinc Sulphate Monohydrate USP Cilostazol INN Zafirlukast INN Pancreatin BP

366 369 371 374 377 379 382 386 389 391 393 395 401

xx

THERAPEUTIC I NDEX

Aeronid
Inhaler

Description Budesonide BP, the active ingredient of Aeronid Inhaler, is a corticosteroid designated that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These antiinflammatory actions of budesonide contribute to their efficacy in asthma. Indications Aeronid Inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Aeronid Inhaler is NOT indicated for the relief of acute bronchospasm. Dosage and Administration Aeronid Inhaler should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, Aeronid Inhaler has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of Aeronid Inhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of Aeronid Inhaler when administered in excess of recommended doses have not been established. The recommended starting dose and the highest recommended dose of Aeronid Inhaler, based on prior asthma therapy, are listed in the following table. 1

Previous Therapy Adults: Bronchodilators alone Inhaled Corticosteroids* Oral Corticosteroids Children: Bronchodilators alone Inhaled Corticosteroids* Oral Corticosteroids

Recommended Starting Dose 200 to 400 g twice daily 200 to 400 g twice daily 400 to 800 g twice daily 200 g twice daily 200 to 400 g twice daily

Highest Recommended Dose 400 g twice daily 800 g twice daily 800 g twice daily 400 g twice daily 400 g twice daily

The highest recommended dose in children is 400 g twice daily

*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Aeronid Inhaler 200 g or 400 g once daily may be considered. Aeronid Inhaler can be administered once daily either in the morning or in the evening.

If the once-daily treatment with Aeronid Inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses. Patients Maintained on Chronic Oral Corticosteroids Initially, Aeronid Inhaler should be used concurrently with the patients usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid 2

withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Aeronid Inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid dose should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or a severe asthma attack, transferred patients may require supplementary treatment with systemic corticosteroids. Contraindication Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to Budesonide contraindicates the use of Aeronid Inhaler. Precautions During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Aeronid Inhaler will often permit control of asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Aeronid Inhaler in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this fact when prescribing Aeronid Inhaler. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. 3

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, Aeronid Inhaler should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic steroids. A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of all paediatric patients taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression. Although patients in clinical trials have received Aeronid Inhaler on a continuous basis for periods of 1 to 2 years, the long-term local and systemic effects of Aeronid Inhaler in human subjects are not completely known. In particular, the effects resulting from chronic use of Aeronid Inhaler on developmental or immunological processes in the mouth, pharynx, trachea, and lung are unknown. In clinical trials with Aeronid Inhaler, localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with Aeronid Inhaler therapy, but at times therapy with Aeronid Inhaler may need to be temporarily interrupted under close medical supervision. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections; or ocular herpes simplex. Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids. Side Effects The following adverse reactions were reported in patients treated with Aeronid Inhaler. 4

General : Headache, flu-like syndrome, pain, back pain, fever, neck pain, asthenia; Respiratory system : Respiratory tract infections, pharyngitis, sinusitis, rhinitis, voice alteration, cough aggravation; Digestive System : Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth, vomiting; Metabolic and Nutritional : Weight gain; Musculoskeletal : Fracture, myalgia, arthralgia; Nervous system : Syncope, hypertonia, migraine; Skin : Ecchymosis; Psychiatric : Insomnia; Resistance Mechanisms : Infection; Special Senses : Taste perversion. Paediatric Studies There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults. Adverse event reports from other sources : Rare adverse events reported include immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis. Pharmaceutical Precautions Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30o C. Keep away from eyes and children. Commercial Pack Aeronid 100 Inhaler : Each canister contains 200 metered doses, each containing 100 g Budesonide BP. Aeronid 200 Inhaler : Each canister contains 200 metered doses, each containing 200 g Budesonide BP.

Alendon
Tablet

Description Alendon is a preparation of Alendronic Acid, a biphosphonate used in the treatment and prevention of osteoporosis in post-menopausal women. Indications Alendon is indicated for: Treatment and prevention of osteoporosis in post-menopausal women

For the treatment of osteoporosis, Alendon increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) For the prevention of osteoporosis, Alendon may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D Treatment of Pagets disease of bone in men and women

Dosage and Administration Treatment of osteoporosis in postmenopausal women The recommended dose is one Alendon 70 tablet (70 mg) once weekly or one Alendon tablet (10 mg) once daily. Treatment to increase bone mass in men with osteoporosis The recommended dose is one Alendon tablet (10 mg) once daily. Alternatively, one Alendon 70 tablet (70 mg) once weekly may be considered. 6

Prevention of osteoporosis in postmenopausal women The recommended dose is 35 mg once weekly or 5 mg once daily. The safety of treatment and prevention of osteoporosis with Alendronic Acid has been studied for up to 7 years. Treatment of glucocorticoid-induced osteoporosis in men and women The recommended dose is 5 mg once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dose is 10 mg once daily. Pagets disease of bone in men and women The recommended treatment regimen is 40 mg once a day for six months. Mode of Administration Swallow the tablet with a full glass of water at least 30 minutes before breakfast (and any other oral medication) on empty stomach. Patients should remain stand or sit upright for at least 30 minutes after taking the tablet and should not be down before eating the first meal of the day. Do not take the tablet at bedtime. Hypocalcemia should be corrected before starting the therapy. Precautions Use in elderly : No dosage adjustment is required for elderly patients. Because in clinical study there was no evidence of age-related differences in the efficacy or safety profiles of Alendronic Acid. Children : It is not recommended for use. Pregnant women : Alendronate should not be given to pregnant women. Contraindication Hypocalcemia; Renal impairment; Vitamin D deficiency; Active gastrointestinal problem such as dysphagia, oesophago-duodenitis or ulcer; Pregnancy and breast feeding and Hypersensitivity to any components of the tablet. Overdosage No such information on overdosage with Alendronate.

Side Effects The commonest symptomatic side effects are constipation, diarrhoea, esophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angioedema. Drug Interactions The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements. Commercial Pack Alendon 70 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Alendronate Sodium BP equivalent to 70 mg of Alendronic Acid. Alendon 10 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Alendronate Sodium BP equivalent to 10 mg of Alendronic Acid.

Alphin DS
Tablet

Description Alphin DS (Albendazole) is a broad spectrum anthelmintic available as chewable tablets, each containing 400 mg of Albendazole USP. It is a very potent benzimidazole carbamate anthelmintic used in the treatment of various intestinal worm infestations and hydatid disease. Indications Alphin DS (Albendazole) is indicated in - Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestations - Enterobiasis, Capillariasis, Cysticercosis and Cutaneous larva migrans - Hydatid disease - Surgery as an adjunct therapy (either pre-or post-operatively) Dosage and Administration The usual dose for adults and children aged 2 years or over with ascariasis (roundworm), hookworm infestations, trichuriasis (whipworm) and cutaneous larva migrans is 400 mg as a single dose. In strongyloidiasis, 400 mg is given daily for 3 consecutive days. This may be repeated after 3 weeks if necessary. In enterobiasis (pinworm, threadworm), children aged 2 years or more have been given a single dose of 100 mg repeated after 7 days; the adult dose is 400 mg repeated after 7 days. In hydatid disease, the usual dose is 400 mg twice daily for adults. This is mostly given for 28-day cycles with a 2-week interval between cycles. The number of cycles ranges from 1 to 12, though 3 cycles may be sufficient for most cysts. Side Effects Gastrointestinal disturbances, headache and dizziness have been reported during treatment. These symptoms are usually mild and resolve without treatment. Rash, fever and rarely alopecia may occur during treatment. Contraindication Albendazole is absolutely contraindicated during pregnancy.

Precautions Elevations in hepatic enzyme levels and reversible reduction in total white cell count have occasionally been reported. These changes appear to be more common during treatment of E. multilocularis. Drug Interactions Albendazole has been shown to induce liver enzymes of the cytochrome P450 system responsible for its own metabolism. There is, therefore, a theoretical risk of interaction with Theophylline, anticonvulsants, anticoagulants, oral contraceptives and oral hypoglycaemics. Care should therefore be exercised during the introduction of Albendazole in patients receiving the above groups of compounds. Overdosage There is no experience of overdosage. Gastric lavage may be performed in the first two to three hours after ingestion. No specific antidote is known. However, symptomatic treatment and general supportive measures should be undertaken as required. Commercial Pack Alphin DS Tablet : Box containing 50 chewable tablets in 5 x 10's aluminium strips, each chewable tablet contains Albendazole USP 400 mg.

10

Amdocal
Tablet

Description Amdocal (Amlodipine) is a dihydropyridine calcium antagonist, with a long duration of action, used for the treatment of hypertension and angina pectoris. Indications Hypertension Amdocal is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Stable Agina Amdocal is indicated for the treatment of stable angina. Amdocal may be used alone or in combination with other antianginal agents. Vasospastic Angina Amdocal is indicated for the treatment of confirmed or suspected vasospastic angina. Amdocal may be used as single therapy or in combination with other antianginal drugs. Dosage and Administration The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amdocal to other antihypertensive therapy. Dosage should be adjusted according to each patients need The recommended dose for stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Contraindication Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. 11

Precautions General : Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patient with Congestive Heart Failure : Although haemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology in general, all calcium channel blockers should be used with caution in patients with heart failure. -blocker withdrawal : Amlodipine gives no protection against the danger of abrupt -blocker withdrawal; any such withdrawal should be gradual reduction of the dose of -blocker. Hepatic Failure : Since Amlodipine is extensively metabolized by the liver, so caution should be exercised when administering Amlodipine to patients with hepatic impairment. Drug interactions No significant drug interaction. Side Effects Peripheral oedema may occasionally be severe but is fully reversible. As with other calcium antagonist drugs, peripheral oedema and skin erythema occur in a proportion of patients (5-10%) and facial flushing in 2-5% of patients. Complaint of fatigue was also reported more frequently than in placebo-treated patients. There is evidence that these effects are more common in patients treated with doses greater than 10 mg daily. Overdosage In humans, experience with intentional overdosage of Amlodipine is limited. If massive overdosage occurs, active cardiac and respiratory

12

monitoring should be instituted. Frequent blood pressure measurements are essential. Commercial Pack Amdocal-5 Tablet : Box containing 5 blister strips of 10 tablets, each tablet contains Amlodipine Besylate INN equivalent to Amlodipine 5 mg. Amdocal-10 Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Amlodipine Besylate INN equivalent to Amlodipine 10 mg.

13

Anustat
Ointment

Description Pale yellow coloured homogenous ointment containing in each gram : Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg, Neomycin Sulphate USP equivalent to Neomycin 10 mg, Esculin Sesquihydrate Ger. P. equivalent to Esculin 10 mg. Action It provides an excellent combination of anti-inflammatory, anti-allergic and antipruritic action of corticosteroid, antibacterial action of locally effective antibiotic Neomycin, local anaesthetic action of Cinchocaine and skin protective action of Esculin. Indications Internal and external haemorrhoid, anal fissure, anal pruritus, perianal eczema, proctitis, pre-operative and post-operative treatment of haemorrhoidectomy, post-partum haemorrhoidal condition and as prophylaxis in between attacks. Dosage and Application A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing. Side Effects and Warning Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using Anustat. Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur.

14

Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence Anustat should not be given to extensively damaged skin. Contraindication Sensitivity to any one of the constituents of Anustat. Pregnancy Topical steroid should not be used extensively in pregnancy. Commercial Pack Anustat Ointment : 15 g ointment in sealed aluminium tube with nozzle for application.

15

Apresin
Tablet

Description Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP combination has been found as an effective preparation for the patients suffering from "anxiety" or "depression" or both. Fluphenazine is a tranquilizer of the phenothiazine type. Nortriptyline is a tricyclic antidepressant having less sedative action. This combination helps to restore functional ability without developing any drug dependence. Dosage and Administration Adults : One Apresin tablet (Fluphenazine HCl 0.5 mg and Nortriptyline 10 mg as Nortriptyline HCl) 2 to 3 times daily. Indications - Mild to moderate mixed anxiety/depression - Emotional disturbance - Sleep disorder - Gastric problems Contraindication It is contraindicated in : - History of gradual epilepsy or organic brain damage - Blood dyscrasia - Severe cardiac insufficiency - Renal or liver damage - Patients taking monoamine oxidase inhibitor (MAOI) - Younger children - Hypersensitivity to any component of the preparation Adverse Effects Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, malignant neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride. 16

Use in Pregnancy and Lactation The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast-milk. Precautions Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery. Drug Interactions Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution. Pharmaceutical Precautions Store in a cool place below 25o C. Keep out of the reach of children. Commercial Pack Apresin Tablet : Box containing 10 blister strips of 10 film coated tablets. Each tablet contains Fluphenazine Hydrochloride BP 0.5 mg and Nortriptyline 10 mg as Nortriptyline Hydrochloride BP.

17

Arbit
Tablet

Description Arbit (Irbesartan) is an antihypertensive drug. It antagonizes angiotensin II receptor (AT1 subtype). Indications Arbit is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Dosage and Administration The recommended initial dose of Arbit is 150 mg once daily. Patients requiring further reduction in blood pressure should be treated to 300 mg once daily. Arbit may be administered with or without food. Contraindication Arbit is contraindicated in patients who are hypersensitive to any component of this product. Side Effects In placebo-controlled clinical trials the adverse event, which occurred in at least 1% of patients treated with Irbesartan and at a higher incidence versus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upper respiratory infection. Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. Rare side effects are urticaria, angioedema, jaundice, hyperkalaemia, and increased liver function tests. Use in Special Populations Paediatric : There is no data on safety and effectiveness of Irbesartan in children. Geriatric : In elderly subjects (age 65-80 years), no dosage adjustment is necessary. Renal Insufficiency : No dosage adjustment is necessary in patients with mild to severe renal impairment.

18

Hepatic Insufficiency : No dosage adjustment is necessary in patients with hepatic insufficiency. Pregnancy and Nursing Mothers : When pregnancy is detected, Arbit should be discontinued as soon as possible. It is not known whether Irbesartan is excreted in human milk, so it should not be prescribed during lactation. Drug Interactions No significant drug interaction has been found in studies with Hydrochlorothiazide, Digoxin, Warfarin, and Nifedipine. Overdosage No data is available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension. Pharmaceutical Precautions Store at temperature between 15C and 30C. Commercial Pack Arbit 75 Tablet : Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Irbesartan INN 75 mg. Arbit 150 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Irbesartan INN 150 mg.

19

Aristocal
Tablet

Description Aristocal contains Calcium Carbonate that is used as dietary calcium supplement, and to sequester phosphorus in the intestine to reduce total body phosphate accumulation in chronic renal failure. Each Aristocal tablet contains 1250 mg Calcium Carbonate BP equivalent to 500 mg elemental Calcium. Indications For dietary calcium supplement when it is deficient As a phosphate binder in chronic renal failure As an adjunct therapy in the arrest or slowing down of bone demineralization in osteoporosis. Dosage and Administration Adults and Elderly : Dietary deficiency- 2 to 3 tablets daily. As Phosphate binder- Dose as required by the individual patient depending on serum calcium and phosphate levels. Adjunct to osteoporosis therapy- 2 to 3 tablets daily. Contraindication Hypercalcaemia and hyperparathyroidism Renal calculi and nephrolithiasis Zollinger-Ellision syndrome and other causes of gastric acid hypersecretion. Adverse Effects Mild gastrointestinal disturbances (e.g. flatulence, abdominal pain, constipation) may occur. Hypercalcaemia and alkalosis are rarely produced with large doses. Precautions In mild hypercalciuria or renal failure or stone formation in urinary tract, adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. 20

Use in Pregnancy and Lactation Calcium containing drugs are used widely in pregnancy by way of oral calcium supplementation. Calcium Carbonate can be used in lactating women too. Drug Interactions Calcium Carbonate may enhance the cardiac effects of Digoxin and other cardiac glycosides if systemic hypercalcaemia occurs. It may interfere with the absorption of concomitantly administered Tetracycline preparations. Modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as a phosphate binder in chronic renal failure. Concurrent administration of Calcium Carbonate reduces total absorption and peak serum levels of Ciprofloxacin. Pharmaceutical Precautions Store in a cool and dry place. Keep out of the reach of children. Commercial Pack Aristocal Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Calcium Carbonate BP equivalent to 500 mg elemental Calcium.

21

Aristoferon
Syrup

Description Aristoferon is a haematinic preparation of Ferrous Sulphate available as raspberry flavored syrup. Each 5 ml of syrup contains 200 mg of Ferrous Sulphate BP. Ferrous Sulphate has the general properties of iron salts and is one of the most widely used iron salts in the treatment of iron deficiency anaemia. Indications Aristoferon is indicated in the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary. Dosage and Administration Adult Initial therapeutic dose : 3-4 teaspoonful daily in divided doses or as prescribed by the physician. Maintenance dose : 1 teaspoonful daily, but if needed up to 1.8 g (9 teaspoonful) daily can be given. Children Under 1 year : th teaspoonful thrice daily or as directed by physician 1-5 years : 1 teaspoonful thrice daily 6-12 years : 1 teaspoonful twice daily Note : i) Mix with water or fruit juice to avoid temporary staining of teeth. ii) Do not mix with milk. Contraindication Iron therapy is contraindicated in haemachromatosis and haemosiderosis. It should not be given to patients receiving repeated blood transfusion or with anaemia not produced by iron deficiency. 22

Precautions Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease. Absorption of iron salt and Tetracycline is diminished when taken concomitantly by mouth. If treatment with both drugs is required iron salt should be given 3 hours before or 2 hours after Tetracycline. Absorption of iron is also decreased in the presence of Antacids or when taken with tea. Side Effects Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhoea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth (this is less likely when diluted). Commercial Pack Aristoferon Syrup : Aristoferon 200 ml syrup in glass bottle, each 5 ml containing 200 mg of Ferrous Sulphate BP.

23

Aristofol-Fe
Tablet

Description Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous Fumarate BP (eqv. to 100 mg of elemental iron) and 350 g of Folic Acid USP. Iron and Folic Acid are required for normal haemopoiesis. Indications Prophylaxis and treatment of iron deficiency anaemia in pregnancy. Prevention of megaloblastic anaemia of pregnancy. Dosage and Administration In anaemia usual dose is one tablet daily.

In severe or refractory iron deficiency anaemia, one tablet twice daily may be given. In Pregnancy, it is recommended that Aristofol-Fe should be started at the first antenatal consultation and continued until 3 months after delivery.

Contraindication Aristofol-Fe is contraindicated in megaloblastic anaemia due to vitamin B 12 deficiency. Precautions Administration of Aristofol-Fe during the first trimester of pregnancy may be undesirable. Very few pregnant women are not protected by physiological doses of folic acid. If anaemia is developed despite prophylaxis with Aristofol-Fe, patients should be investigated further. Some postgastrectomy patients show poor absorption of iron. Care is needed when treating patients with peptic ulcer. When Aristofol-Fe and Tetracycline are taken concomitantly, absorption of both drugs are reduced. Concurrent administration of antacid may reduce absorption of iron. Serum anticonvulsant levels may be reduced by administration of folate. 24

Side Effects Gastrointestinal disorders and allergic reactions have been reported. Treatment of Overdosage Ingestion of an overdose of iron orally requires emergency treatment along the following lines. Vomiting should be induced immediately, followed (as soon as possible) by parenteral injection of Desferrioxamine Mesylate and then gastric lavage. In the mean time it is helpful to give milk and or 5% sodium bi-carbonate solution by mouth. Intramuscular desferrioxamine injection may be given. A desferrioxamine solution (5 g in 50-100 ml) may be left in the stomach. If Desferrioxamine is not available, 300 ml of 1% to 5% sodium bi-carbonate solution should be left in the stomach. Fluid replacement is essential. Commercial Pack Aristofol-Fe Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous fumarate (eqv. to 100 mg of elemental iron) and 350 g of Folic Acid.

25

Aristoplex
Syrup

Description Aristoplex is a liquid preparation of Vitamin B-Complex. Each 5 ml Aristoplex syrup contains: Thiamine Hydrochloride (Vitamin B1) Riboflavin (Vitamin B2 ) Pyridoxine Hydrochloride (Vitamin B6) Nicotinamide BP USP BP BP 5 mg 2 mg 2 mg 20 mg

Indications Prevention and treatment of Vitamin B-Complex deficiency states, manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis.

Maintenance of normal growth and health during the early days of children. Apathy and anorexia in elderly patients. Prevention of vitamin deficiencies, particularly when depletion is suspected; - Pregnancy and lactation - Convalescence during debilitating illness - Patients on restricted diets

Dosage and Administration Adults and Elderly : One to two 5 ml spoonful syrup three times a day. Children : One 5 ml spoonful syrup three times a day. Infants : One 5 ml spoonful syrup daily.

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Contraindication Known hypersensitivity to any of the active constituents. Precautions Pyridoxine may reduce the therapeutic efficacy of Levodopa. Use in Pregnancy and Lactation As with all medicines, careful considerations should be given before the administration of B-Complex preparations during the first trimester of pregnancy. Vitamins are excreted in breast milk. Pharmaceutical Precautions Store in a cool place. The syrup should be protected from light. Commercial Pack Aristoplex Syrup : Aristoplex syrup is available in 100 ml and 200 ml amber glass bottle. Each 5 ml Aristoplex syrup contains multivitamin.

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Aristovit-B
Tablet

Description Aristovit-B is a sugar coated tablet containing different B-Vitamins. Each tablet contains 20 mg of Nicotinamide USP, 2 mg of Pyridoxine Hydrochloride USP, 2 mg of Riboflavin USP and 5 mg of Thiamine Mononitrate USP. Indications Aristovit-B is indicated in the treatment and prevention of Vitamin B deficiencies, particularly when depletion is suspected, such as in case of pregnancy and lactation, convalescence following debilitating illness and in restricted diet. Dosage and Administration One or two tablets three times daily. Contraindication Contraindicated in case of hypersensitivity to any of the active ingredients of Aristovit-B. Precaution Should be given cautiously to patients taking Levodopa as Pyridoxine reduces the effect of Levodopa. Commercial Pack Aristovit-B Tablet : Bottle containing 45 sugar coated tablets. Each sugar coated tablet contains different B-Vitamin.

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Aristovit-M
Tablet

Description Aristovit-M is sugar-coated multivitamin-mineral tablet. Each tablet contains : Vitamin A Vitamin D Thiamine Mononitrate (B1) Riboflavin Ascorbic Acid Nicotinamide Pyridoxine HCl (B6) Folic Acid Calcium Pantothenate Cyanocobalamin (B12) Vitamin E Ferrous Sulphate Potassium Iodide Potassium Sulphate Manganese Sulphate Monohydrate Cupric Sulphate Pentahydrate Zinc Sulphate USP USP USP USP USP USP USP USP USP USP USP USP USP BP USP USP USP 1.5 mg 10 g 1.5 mg 1.7 mg 60 mg 20 mg 2 mg 0.4 mg 10.92 mg 6 g 10.05mg 50 mg 196 g 11.14 mg 1 mg 2 mg 37.04 mg

Indications Deficiency states in acute and chronic disease. Conditions regarding specific support : pregnancy, lactation, menopause, during treatment with antibiotics. The comprehensive formulae of Aristovit-M assures liberal amounts of important vitamins, minerals and trace elements needed by the body during periods of increased energy requirements such as in disease and convalescence. Dosage and Administration One tablet daily or as advised by the physician.

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Contraindication Supplemental vitamins and minerals should not be prescribed for patients with haemochromatosis or Wilsons disease. Hypersensitivity to any of the active ingredients is a contraindication. Excessive doses of vitamin A and D can lead to hypervitaminosis. When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. This is particularly important during the first trimester of pregnancy when large doses of Vitamin A may be teratogenic. Iron and Zinc chelate with Tetracyclines and absorption of all three agents may be impaired. Side Effects Multivitamin preparation with ordinary doses of component are usually nontoxic. Precautions Aristovit-M may be used in patients being treated for Parkinsons disease with a Levodopa preparation which includes a dopa-decarboxylase inhibitor (e.g. Carbidopa, Benserazide). But precautions should be taken Pyridoxine acts as an antagonist of Levodopa. Pharmaceutical Precautions Store in a cool and dry place at a temperature not exceeding 25C and protect from light. Commercial Pack Aristovit-M Tablet : Bottle containing 30 sugar coated tablets. Each sugar coated tablet contains multivitamin and mineral.

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Aristovit-X
Tablet

Description Aristovit-X is a special formulation comprising of important vitamin, anti-oxidants and minerals. Each tablet contains: Vitamin A Vitamin E Vitamin K Vitamin C Zinc Copper Manganese Selenium 2000 IU 50 IU 75.00 g 200.00 mg 15.00 mg 1.00 mg 3.00 mg 70.00 g

Indications Aristovit-X is a once-daily tablet indicated for use to develop immune system, help prevent the well-known deficiency diseases such as scurvy, beriberi, pellagra and others, prevent certain types of cancer by blocking the formation of cancer causing substances in the body. It is also capable of combating cardiovascular and immunological disorders. Aristovit-X helps strengthen immune system, keeping free from sickness and allowing a better, harder workout. Dosage and Administration Aristovit-X may be administered once daily or as indicated by the physician. Contraindication Aristovit-X is contraindicated in patients with a known hypersensitivity to any of the ingredients. Side Effects Generally well tolerated.

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Precautions Excess vitamin A intake may be toxic and may increase the risk of birth defects. Pregnant women and women who may become pregnant should not exceed total 5000 IU of vitamin A (retinyl palmitate) per day. Drug Interactions No drug interactions have been reported. Use in Pregnancy and Lactation Aristovit-X is recommended in pregnancy and lactation Pharmaceutical Precautions Tablets should be stored below 25 C and protected from light and moisture. Commercial Pack Aristovit-X Tablet : Plastic bottle containing 30 film coated tablets. Each tablet contains multivitamin, antioxidants and minerals.

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Arixon
Injection

Description Arixon (Ceftriaxone) is highly stable to most -lactamase, both penicillinases and cephalosporinases of Gram-positive and Gramnegative bacteria. The action of Arixon is bactericidal which inhibits the cell wall synthesis. It is most effective against the following microorganisms: Gram-positive bacteria: Staphylococcus aureus (including penicillinase producing strains), Staphylococcus epidermis, Streptococcus, Streptococcus pneumoniae, Streptococcus bovis. Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including penicillinase-producing strains), Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris. Indications It is indicated for the treatment of sepsis; meningitis; abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts), infections of the bones, joints, soft tissue, skin and/or wounds infections in patients with impaired defense mechanism; renal and urinary tract infections; respiratory tract infections, particularly pneumonia, and ear, nose and throat infections, and genital infections including gonorrhoea. Dosage and Administration Adults and children over twelve years : The usual dosage is 1 to 2 g of Arixon administered once daily in 24 hours. In severe cases infections caused by moderately sensitive organisms, the dose may be increased to 4 g once daily. Neonates, infants and children up to 12 years : For Neonates (up to 2 weeks) a daily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg on account of the immaturity of the infants is advised. For children with body weight of 50 kg or more, the usual adult dose should be used.

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Elderly patients : The dosage recommended for adults require no modification in case of geriatric patients. Duration of Therapy The duration of therapy varies according to the course of the diseases. As with antibiotic therapy in general administration, Arixon should be continued for a minimum of 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained. For the treatment of gonorrhoea, a single intramuscular dose of 250 mg Arixon is recommended. Precautions As with other cephalosporins anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate counter measures. Side Effects Diarrhoea, nausea, vomiting, stomatitis and glossitis. Pharmaceutical Precautions Arixon should be stored at below 30o C. Commercial Pack Arixon 250 mg IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 2 ml Lignocaine Injection BP 1%. Arixon 500 mg IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 2 ml Lignocaine Injection BP 1%. Arixon 1 g IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 3.5 ml Lignocaine Injection BP 1%. Arixon 250 mg IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 5 ml Water for Injection BP.

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Arixon 500 mg IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 5 ml Water for Injection BP. Arixon 1 g IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 10 ml Water for Injection BP.

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Arlin
Tablet/Suspension

Description Arlin contain Linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. Arlin film coated tablets for oral administration contain 400 mg or 600 mg Linezolid. Arlin oral suspension is supplied as powder for reconstitution into a suspension for oral administration. Indications Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (penicillin-susceptible strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organisms. Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillinsusceptible only) or Streptococcus pyogenes. Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only). Dosage and Administration i) Vancomycin- resistant Enterococcus faecium infections, including concurrent bacteremia, recommended dose is 600 mg 12 hourly for 14 to 28 days. ii) Nosocomial pneumonia, Complicated skin and skin structure infections, and Community-acquired pneumonia, including concurrent bacteremia, recommended dose is 600 mg 12 hourly for 10 to 14 days. iii) Uncomplicated skin and skin structure infections recommended dose is 400 mg 2 hourly for 10 to 14 days.

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Contraindication Arlin formulations are contraindicated for use in patients who have known hypersensitivity to Linezolid or any of the other product components. Side Effects Most of the adverse events reported with Arlin are mild to moderate in intensity. The most common adverse events in patients treated with Arlin were diarrhoea, headache and nausea. Other adverse events included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discolouration. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. Arlin should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Arlin is administered to a lactating woman. Drug Interactions Monoamine Oxidase Inhibitors: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents. Adrenergic Agents : Some individuals receiving Arlin may experience a reversible enhancement of the pressor response to sympathomimetic agents, vasopressor or dopaminergic agents. Commonly used drugs such as Phenylpropanolamine and Pseudoephedrine have been specifically studied. Initial doses of adrenergic agents, such as Dopamine or Epinephrine, should be reduced and titrated to achieve the desired response. Serotonergic Agents : Co-administration of Linezolid and serotonergic agents was not associated with serotonin syndrome in studies. Since there is limited experience with concomitant administration of Linezolid and serotonergic agents, physicians should be alert to the possibility of signs and symptoms of serotonin syndrome (e.g. hyperpyrexia and cognitive dysfunction) in patients receiving such concomitant therapy. 37

Overdosage In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Haemodialysis may facilitate more rapid elimination of Linezolid. Pharmaceutical Precautions Store at temperature between 15o C and 30o C. Commercial Pack Arlin 400 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each film coated tablet contains Linezolid INN 400 mg. Arlin 600 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each film coated tablet contains Linezolid INN 600 mg. Arlin Powder for Suspension : Dry Powder in amber glass bottle for reconstitution into 100 ml Suspension. After reconstitution each 5 ml contains Linezolid INN 100 mg.

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Ascobex
Tablet

Description Ascobex tablet contains Ascorbic Acid USP 100 mg, Sodium Ascorbate USP 168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C). Ascorbic Acid (Vitamin C) is essential for synthesis of collagen and intracellular materials. It is involved in important metabolic reactions. Deficiency may arise due to decrease in absorption or increase in requirement due to certain physiological conditions such as pregnancy, lactation, post-operative state, growing age etc. Ascobex can be used to treat vitamin C deficiency and in those conditions where there is an increased requirement of vitamin C. Ascobex is also used as an antioxidant vitamin. Indications Vitamin C deficiency disorders, pregnancy, lactation, post-operative or other wound healing state, infection, growing age, thyrotoxicosis, and common cold. Being an antioxidant vitamin, it protects against cardiovascular diseases, atherosclerosis, malignancy and it has been found to delay the aging process. It has been found that in case of diabetes, there is an increase in requirement of vitamin C, Ascobex is also indicated in that condition. Dosage In scurvy In wound healing In other conditions

: : :

4 tablets 2 to 3 times daily 2-4 tablets 2 to 3 times daily 1-2 tablets daily

Precautions Should be given with caution to patient with hyperoxaluria. Tolerance may be induced in patients taking higher doses.

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Side Effects Ascorbic acid does not seem to have any important adverse effects at dosages less than 4 mg/day. Larger dose may cause diarrhea or formation of renal calculi of calcium oxalate in patients with renal impairment. Ingestion of more than 600 mg daily have a diuretic action. Commercial Pack Ascobex Tablet : Box containing 200 tablets in 10 X 20s blister strips, each tablet contains Ascorbic Acid USP 100 mg, Sodium ascorbate USP 168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C).

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Atova
Tablet

Description Atova (Atorvastatin Calcium) is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoA to mevatonate, an early and rate limiting step in the synthesis of cholesterol. Indications Atova is indicated as an adjunct to diet to reduce elevated total cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein B and triglyceride (TG) levels in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types lla and llb). Atova is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Atova is indicated for the treatment of patients with primary dysbetalipoproteinaemia (Fredrickson Type III) who do not respond adequately to diet. Atova is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Therapy with lipid altering agent should be a component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolaemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures have been inadequate (see Table 1). At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is >130 mg/dl [National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II)]. 41

Prior to initiating therapy with Atova, secondary causes for hypercholesterolaemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For patients with TG<400 mg/dl (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C=total-C (0.20 x [TG] + HDL-C). For TG levels >400 mg/dl (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
TABLE 1 - NCEP GUIDELINES FOR LIPID MANAGEMENT Definite Atherosclerotic Diseasea No No Yes Two or More Other Risk Factorsb No Yes Yes or No LDL-Cholesterol mg/dl (mmol/L)

Initiation Level
>190 (>4.9) >160 (>4.1) >130 c (>3.4)

Minimum Goal
<160 (<4.1) <130 (<3.4) <100 (<2.6)

a. Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). b. Other risk factors for coronary heart disease (CHD) include: age (males >45 years; females >55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dl (< 0.91 mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is > 60 mg/dl (>1.6 mmol/L). c. In CHD patients with LDL-C levels 100 to 129 mg/dl, the physician should exercise clinical judgement in deciding whether to initiate drug treatment.

Dosage and Administration Adults : The patient should be placed on a standard cholesterol-lowering diet before receiving Atova and should continue on this diet during treatment with Atova.

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Hypercholesterolaemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidaemia (Fredrickson Types IIa and IIb) : The recommended starting dose of Atova is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atova can be administered as a single dose at any time of the day with or without food. Therapy should be individualized according to goal of therapy and response. After initiation and/or upon titration of Atova, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Since the goal of treatment is to lower LDL-C, the LDL-C levels should be used to initiate and assess treatment response. Only if LDL-C levels are not available, total-C should be used to monitor therapy. Homozygous Familial Hypercholesterolaemia : The dosage of Atova in patients with homozygous Familial Hypercholesterolaemia is 10 to 80 mg daily. Atova should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavoidable. Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required. Haemodialysis is not expected to significantly enhance the clearance of Atorvastatin since the drug is extensively bound to plasma proteins. Patients with hepatic dysfunction: In patients with moderate to severe hepatic dysfunction, the therapeutic response to Atorvastatin is unaffected but exposure to the drug is greatly increased. C max increases by approximately 16 fold and AUC (0-24) by approximately 11 fold. Therefore, caution should be exercised in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Contraindication Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal. Use in Pregnancy and Lactation Safety in pregnancy has not been established. Rare reports of congenital

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anomalies have been reported following intrauterine exposure to HMGCoA reductase inhibitors. HMG-CoA reductase inhibitors are not recommended for use during pregnancy. An interval of 1 month should be allowed from stopping Atorvastatin treatment to conception in the event of planning a pregnancy. Use of HMG-CoA reductase inhibitors during breast feeding is not recommended, because of the potential for serious adverse effects in nursing infants. Use in Special Population Children : Safety and efficacy of Atorvastatin have not been established in children. Geriatrics : Efficacy and safety in older patients using recommended doses is similar to that seen in the general population. Carcinogenicity/mutagenicity Atorvastatin was not found to be carcinogenic in rats; the maximum dose used was 63 fold higher than the highest human dose (80 mg/day) on a mg/kg body weight basis. Precautions Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatinephosphokinase (CPK) levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of Cyclosporin, fibric acid derivatives, Erythromycin, Niacin, or azole anti-fungals. Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 44

Side Effects Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhoea, asthenia and insomnia. Dose related and reversible elevated serum alanine transaminase (ALT) levels have been reported in approximately 1.3% of patients receiving Atorvastatin. Elevated serum CPK levels have been reported in some patients on Atorvastatin but only in rare cases patients may have muscle pain, tenderness or weakness. Other side effects reported in clinical trials (not all effects have necessarily been associated with Atorvastatin therapy) include muscle cramps, myopathy, paresthesia, peripheral neuropathy, pancreatitis, hepatitis, cholestatic jaundice, anorexia, vomiting, pruritus, rash, impotence, hyperglycaemia and hypoglycaemia. Chest pain, dizziness, angina and allergic reactions have been reported in isolated cases. Overdosage There is no specific treatment available for Atorvastatin overdosage. General supportive measures should be adopted as required. Liver function tests and serum CPK levels should be monitored. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance Atorvastatin clearance. Pharmaceutical Precautions Storage below 20o C, protected from moisture. Commercial Pack Atova 10 Tablet : Box containing 10 tablets in 1 x 10s blister strip, each tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 10 mg. Atova 20 Tablet : Box containing 10 tablets in 1 x 10s blister strip, each tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 20 mg.

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Atrizin
Tablet/Syrup

Description Atrizin is available in both tablet and syrup form. Each film coated tablet contains Cetirizine Hydrochloride BP 10 mg and each 5 ml cherry flavoured syrup contains 5 mg of Cetirizine Hydrochloride BP. Cetirizine is a piperazine derivative and a potent functional antagonist of histamine H 1 receptors. Atrizin is a long acting antihistamine. Central sedation or antimuscarinic effects do not generally occur with the usual doses of Atrizin. Indications Atrizin is indicated for the prevention and symptomatic relief of allergic manifestations, such as: - Seasonal allergic rhinitis - Perennial allergic rhinitis - Chronic idiopathic urticaria Dosage and Administration Atrizin tablet : Adults and children over 12 years- 10 mg (1 tablet) once daily. Atrizin syrup: Adult and Children over 6 years- 10 mg (2 teaspoonful) daily. Child 2-6 years- 5 mg (1 teaspoonful) daily or 2.5 mg ( teaspoonful) twice daily. The maximum recommended dose is 20 mg (2 tablets or 4 teaspoonful) daily. Cetirizine is safe for use in the elderly patients. Less frequent dosing is advised in patients with reduced creatinine clearance. Contraindication Cetirizine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound- Hydroxyzine. Adverse Reaction No potentially life threatening effects have been encountered. 46

Acute Overdosage In the occasional cases patient taking a massive intentional overdose (150300 mg), sedation has been the only adverse effect and complete recovery has ensured. Like other H1 receptor antagonists, Cetirizine has no specific antidote. Precautions Neonates : The drug is not usually administered to neonates. Children : Cetirizine is effective and well tolerated in children. No special precautions are required in children over 6 years of age. Use in Pregnancy and Lactation Cetirizine is not teratogenic in animals. Since the animal studies are not always predictive of human response, it should be used only if the potential benefit justifies the potential risk to the foetus. The extent of Cetirizine excretion in human breast milk is unknown but some animal studies have shown excretion in breast milk. Nursing mothers are advised not to take this medication. Drug Interaction There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or Diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone. Commercial Pack Atrizin Tablet : Box containing 10 blister strips of 10 film coated tablets, each tablet contains Cetirizine Hydrochloride BP 10 mg. Atrizin Syrup : Amber glass bottle containing 60 ml syrup. Each 5 ml syrup contains Cetirizine Hydrochloride BP 5 mg .

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Avastin
Tablet

Description Avastin is a preparation of Simvastatin which acts as a cholesterol lowering agent. Avastin inhibits 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, an enzyme which catalyses the biosynthesis of cholesterol. Mode of Action The main mechanism of reduction of low density lipoprotein (LDL) cholesterol is that, following inhibition of HMG-CoA reductase activity, the LDL receptor density on the liver cells is increased and this leads to an increased removal of LDL cholesterol from the plasma and increased catabolism of LDL cholesterol. In addition, there is a reduction in very low-density lipoprotein (VLDL) cholesterol and reduced formation of LDL from VLDL. Indications Avastin is indicated in patients with primary hypercholesterolaemia who have not responded adequately to diet and other appropriate measures. To reduce incidence of clinical coronary events and slow progression of coronary atherosclerosis in patients with coronary heart disease and cholesterol concentration of 5.5 mmol/litre or greater. Dosage and Administration The patients should be placed on a standard cholesterol-lowering diet before receiving Avastin and maintained on it during treatment. Doses should be individualized according to baseline LDL-cholesterol levels, the recommended goal of therapy and the patients response. Adjustment of dosage should be at intervals of 4 weeks or more. In hypercholesterolaemia, the recommended starting dose is 5-10 mg once a day in the evening. The recommended dose range is 5-40 mg per day as a single dose in the evening.

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The patients with coronary heart disease and hypercholesterolaemia, the starting dose should be 20 mg once a day in the evening. Safety and effectiveness in children and adolescents have not been established. Contraindication Hypersensitivity to any component of the preparation; Active liver disease; Pregnancy and lactation; women of child-bearing potential unless adequately protected by contraception; in patients with the homozygous form of familial hypercholesterolaemia, in whom there is a complete absence of LDL receptors. As Simvastatin has only a moderate triglyceride-lowering effect, it is not indicated where hypertriglyceridaemia is the abnormality of most concern. Side Effects Avastin is generally well tolerated, no potentially life-threatening effects have been reported. Headache, fatigue, insomnia, gastrointestinal effects like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal cramps, and muscular effects like myalgia, myositis and myopathy have been reported. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with Simvastatin therapy. Hepatitis, pancreatitis, rash, angioedema have also been reported. Drug Interactions Digoxin : Concomitant administration of Simvastatin and Digoxin in normal volunteers resulted in a slight elevation (less than 0.3 ng/ml) in drug concentrations in plasma compared to concomitant administration of placebo and Digoxin. Coumarin derivatives : The administration of Simvastatin appeared to enhance slightly the anticoagulant effect of Warfarin (mean changes in prothrombin time less than two seconds) in normal volunteers maintained in a state of low therapeutic anticoagulation. Others : In clinical studies, Simvastatin was used concomitantly with angiotensin-converting enzyme (ACE) inhibitors, -blockers, calcium channel blockers, diuretics and non-steroidal 49

anti-inflammatory drugs (NSAIDs) without evidence of clinically significant adverse interactions. Precautions Monitor liver function before and during treatment; History of liver disease (avoid if active); High alcohol intake; Avoid pregnancy during and for 1 month after treatment; Advise patients to report if there is any muscle pain. Simvastatin should be discontinued if markedly elevated CPK levels occur or if myopathy is diagnosed. Overdosage There are no data available on overdose. No antidote is available. General measures should be adopted and liver function should be monitored. Commercial Pack Avastin Tablet : Box containing 30 film coated tablets in 3 x 10s blister strips, each tablet contains Simvastatin USP 10 mg.

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Avidro
Tablet

Description Avidro is the brand name of Pizotifen, which is a tricyclic compound having antiserotoninergic and antihistaminic effects together with a weak anticholinergic action. Pizotifen inhibit the permeability-increasing effects of serotonin and histamine on the affected cranial vessels, thereby checking the transudation of plasmakinin so that pain threshold of the receptors is maintained at normal levels. In the sequence of events leading to the migraine attack, depletion of plasma serotonin contributes to loss of tone in the extra-cranial vessels. Pizotifen inhibits serotonin reuptake by the platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive distension of the extra-cranial arteries. Indications It is used as prophylactic treatment of vascular headaches of the migraine types, such as classic migraine, common migraine and cluster headache. Dosage and Administration Adult : Usually 1.5 mg daily, which may be taken as a single dose at night or in three divided doses. Dose should be adjusted to individual patient's requirements. Up to a maximum of 4.5 mg daily and up to 3 mg may be given as a single dose daily. Children : Up to 1.5 mg daily, usually in divided dose, and daily 1 mg as a single dose has been given at night using 0.5 mg tablet. Duration of treatment : 3-6 months; minimum one month to observe the benefit. Contraindication Although its anticholinergic activity is relatively weak, Pizotifen should probably not be administered in presence of narrow angle glaucoma or prostate hypertrophy. It should not be given in patients with hypersensitivity to this drug.

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Use in Pregnancy and Lactation Information of using Pizotifen in pregnancy is limited, so it should only be used during pregnancy under compelling circumstances and it is not recommended to the nursing mother. Side Effects Drowsiness is the most common side effect and also increased appetite, which may lead to increase in body weight. Other side effects are, dizziness, dry mouth, nausea, constipation, which are rare. In children central nervous system (CNS) stimulation may occur. Precautions Patients should be cautioned about the possibility of drowsiness and informed of its significance in driving vehicles and operation of machineries. Pizotifen may enhance the central effects of sedatives, hypnotic, antihistamines and alcohol. Dose adjustment may be required in patients with renal insufficiency. Commercial Pack Avidro 0.5 Tablet : Box containing 10 x 10's tablets in blister strips. Each film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 0.5 mg. Avidro 1.5 Tablet : Box containing 5 x 10's tablets in blister strips. Each film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 1.5 mg.

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Avifanz
Tablet

Description Avifanz is the brand name for Efavirenz. Efavirenz, a synthetic antiretroviral agent, is a non-nucleoside reverse transcriptase inhibitor. While Efavirenz is pharmacologically related to other non-nucleoside reverse transcriptase inhibitors, Efavirenz differs structurally from these drugs and also differs structurally from other currently available anti-retroviral agents. Indications Avifanz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection. This indication is based on analysis of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV- RNA with Avifanz. Dosage and Administration Adults : The recommended dosage of Avifanz is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). Avifanz may be taken with or without food; however, a high fat meal may increase the absorption of Avifanz and should be avoided. In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms. Avifanz must be given in combination with other antiretroviral medications. Paediatric Patients : The following table describes the recommended dose of Avifanz for paediatric patients 3 years of age or older and weighing between 10 to 40 kg. The recommended dosage of Avifanz for paediatric patients weighing greater than 40 kg is 600 mg, once daily.

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Body Weight Kilogram 10 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 40< Pound 22 to < 33 33 to < 44 44 to < 55 55 to < 71.5 71.5 to < 88 88<

Avifanz Dose (mg) 200 250 300 350 400 600

Paediatric Dose to be Administered Once Daily Contraindication Efavirenz is contraindicated in patients with known hypersensitivity to the drug or any ingredient in formulation. Warning and Precautions The drug should not be used in pregnant women or who plan to become pregnant, and also in lactating women. High fat foods may cause unwanted increases in drug effect, so avoid taking this drug with high-fat foods. Regular, periodic measurement plasma HIV-1 RNA levels and CD4+ Tcell counts is necessary to determine the risk of disease progression and to determine when to modify anti-retroviral agent regimens. Patients should be advised that Efavirenz has not been shown to reduce the risk of transmission of HIV to others via sexual contact or blood contamination and so the practices designed to prevent transmission of HIV should be maintained during anti-retroviral therapy. Efavirenz should always be administered in conjunction with other anti-retroviral agent and should not be used alone in the treatment of HIV infection. Although Efavirenz used in combination with other anti-retroviral agents appears to be well tolerated, patients should be monitored closely for adverse effects during combination therapy. The usual precautions and contraindication of the other anti-retrovirals in the regimen should be considered during combination therapy; Efavirenz should not be added as sole agent to a failing regimen. Whenever a change in anti-retroviral therapy is considered because of therapeutic failure, at least 2 components of the previous regimen should be changed since adding a 54

single new agent may predispose to the development of viral resistance. Use of an entirely new regimen containing at least 3 drugs is preferred. The effect of Efavirenz therapy on subsequent therapy with other nonnucleoside reverse transcriptase inhibitors remains to be determined. Because cross-resistance occurs among non-nucleoside reverse transcriptase inhibitors, most clinicians suggest that individuals who experience disease progression while receiving one of the agents (e.g., Delavirdine, Efavirenz, Nevirapine) should not be switched to another agent in the class. As Efavirenz has been associated with adverse CNS effect, patients should be advised that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination such as operating machinery or driving a motor vehicle. In addition, patients receiving Efavirenz should be informed that there is a potential for additive CNS effects if they use Efavirenz concomitantly with psychoactive drugs or alcohol. Patients should be advised to contact their clinician if they experience delusions, inappropriate behaviour, or acute depression while receiving Efavirenz; discontinuance of the drug may be necessary in patients who experience such CNS effects. Efavirenz is metabolized in the liver; the drug should be used with caution in patents with hepatic impairment. Serum hepatic enzyme concentrations should be monitored during Efavirenz therapy in patients who have, or may have, Hepatitis B and/or C virus infection, in patients receiving concomitant Ritonavir and in patients receiving concomitant therapy with hepatotoxic drug(s). In patients with serum hepatic enzyme concentrations more than 5 times the upper limit of normal, the benefits of continued Efavirenz therapy versus the risks of hepatotoxicity should be considered. Because increases in serum cholesterol concentration have occurred in individuals receiving Efavirenz, cholesterol monitoring should be considered in patients receiving the drug. Because of the risk of foetal malformations, Efavirenz should not be used in women who are or may become pregnant unless no other therapeutic options exist. Precautions Efavirenz may cause drowsiness or dizziness. Alcohol may intensify this effect. Paediatric Precautions Safety and efficacy of Efavirenz in neonates and children younger than 3 years of age or who weigh less than 13 kg have not been evaluated. 55

Adverse effects including CNS, gastrointestinal and dermatologic effects reported in children receiving Efavirenz are similar to those reported in adults receiving the drug. Adverse CNS effects occurred in 9% of children receiving Efavirenz. In clinical studies rash has been reported more frequently in children than adults (40 vs 27.3% ) and the incidence of moderate to severe rash has been greater in children than adults. Because of the high incidence of dermatologic reactions in children, antihistamines may be used for the prevention of rash when initiating Efavirenz therapy in children; however, the efficacy of such a strategy has not been determined. Side Effects Central Nervous System (CNS) : Dizziness, impaired concentration, abnormal dreams and insomnia have been reported in about 52% of adults receiving Efavirenz 600 mg once daily. In clinical studies these adverse effects were reported in 26% of adults in the control groups not receiving Efavirenz. In adults receiving Efavirenz, these CNS effects were described as mild (do not interfere with daily activities) in 31.4%, moderate (may interfere with daily activities) in 17.8% or severe (interrupt usual daily activities) in 2.6% cases. Adverse nervous system effects generally begin during the first 1-2 days of drug therapy, improve with continued therapy and usually resolve after the first 1-2 days of therapy. Adverse CNS effects may be more tolerable if the daily dose of Efavirenz is administered at bedtime, especially during the first 2-4 weeks of therapy and in patients who continue to experience such effects. Fatigue has been reported in up to 7% of adults receiving the drug in clinical studies. Severe acute depression, sometimes accompanied by suicidal ideation/ attempts, has been reported rarely in patients receiving Efavirenz in clinical studies. Adverse CNS effects reported in less than 2% of patients receiving Efavirenz include ataxia, confusion, impaired coordination, migraine headache, neuralgia, paresthesia, peripheral neuropathy, seizures, speech disorder, tremor, or vertigo. In addition, aggravated depression, agitation, amnesia, anxiety, apathy, emotional liability, euphoria, hallucination, or psychosis has occurred in less than 2% of Efavirenz-treated patients.

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Adverse CNS effects occurred in 9% of children receiving Efavirenz in clinical studies. Dermatologic reactions : Rash has occurred in 27. 3% of adults receiving Efavirenz in clinical studies and in 17% of adults in control groups not receiving the drug. Pruritus or increased sweating has been reported in 12% of patients receiving the drug. Allergic reaction, alopecia, eczema, folliculities, skin exfoliation or urticaria has occurred in lees than 2% of patients receiving the drug. Gastrointestinal : Nausea or diarrhoea has been reported in up to 12% of adults receiving the drug. Vomiting, dyspepsia, abdominal pain, or flatulence has occurred in some Efavirenz-treated adults. Dry mouth or taste change has been reported in up to 2% of patients receiving the drug. Hepatic : Hepatitis occurred in less than 2% of patients receiving the drug. Cardiovascular : While the clinical importance remains to be determined, total serum cholesterol concentrations have been increased 10-20% in healthy individuals receiving the drug. Hot flushes, flushing, palpitations, tachycardia, or thrombophlebitis has been reported in less than 2%, of patients receiving the drug. Pharmaceutical Precautions Store in a cool dry place. Keep out of reach of children. Commercial Pack Avifanz Tablet : Each box contains 1 x 10s tablets in blister strip. Each tablet contains Efavirenz INN 600 mg.

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Avifix
Tablet

Description Avifix (Nelfinavir Mesylate), a human immunodeficiency virus (HIV) protease inhibitor, is available as film coated tablet in 250 mg strength (as Nelfinavir free base). Indications Avifix is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Dosage and Administration Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. Avifix should be taken with meal. Antiviral activity is enhanced when Avifix is administered in combination with nucleoside analogues. Therefore, it is recommended that Avifix be used in combination with nucleoside analogues. Paediatric Patients : The recommended oral dose of Avifix for paediatric patients 2 to 13 years of age is 20-30 mg/kg per dose, three times daily with a meal. Contraindication Avifix is contraindicated in patients with clinically significant hypersensitivity to any of its components. Co-administration of Avifix is contraindicated with drugs that are highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated plasma concentrations are associated with serious and/or lifethreatening adverse events. Warning and Precautions Avifix should not be administered Astemizole, Cisapride, Triazolam, Amiodarone or Quinidine because metabolism of these drugs and create threatening adverse events. 58 concurrently Midazolam, Avifix may potential for with Terfenadine, ergot derivatives, affect the hepatic serious and/or life-

New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycaemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycaemia persisted in some cases. Precautions for Special Population Hepatic Impairment : Nelfinavir is principally metabolized by the liver. Therefore, caution should be exercised when administering this drug to patients with hepatic impairment. Haemophilias : There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis, in patients with haemophilia type A and B treated with protease inhibitors. In some patients, additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship has not been established. Paediatric : A similar adverse event profile was seen during the paediatric clinical trial as in adult patients. The evaluation of the antiviral activity of Nelfinavir in paediatric patients is ongoing. The safety, effectiveness and pharmacokinetics of Nelfinavir have not been evaluated in paediatric patients below the age of 2 years. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. To avoid postnatal transmission of HIV, the US Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast feed their infants. Side Effects The safety of Nelfinavir was studied in over 1500 patients who received the drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving Nelfinavir was diarrhoea, which was generally of mild to moderate intensity.

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Adverse events occurring in less than 2% of patients receiving Nelfinavir in all phase II/III clinical trials are considered at least possibly related or of unknown relationship to treatment. They are listed belowGeneral : abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain and redistribution/accumulation of body fat. Digestive System : anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting. Haematologic : anaemia, leucopenia and thrombocytopenia. Metabolic/Nutritional : increase in alkaline phosphate, amylase, CPK, lactic dehydrogenase, asparpate transaminase (AST), ALT and gamma glutamyl transpeptidase. Hyperlipaemia, hyperuricaemia, hyperglycaemia, hypoglycaemia, dehydration, and abnormal liver function tests. Musculoskeletal System : arthralgia, arthritis, cramps, myalgia, myasthenia and myopathy. Nervous System : anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, somnolence and suicide ideation. Respiratory System : dyspnoea, pharyngitis, rhinitis and sinusitis. Skin/Appendages : dermatitis, folliculitis, fungal maculopapular rash, pruitus, sweating, and urticaria. Special Senses : acute iritis and eye disorder. Urogenital System : kidney calculas, sexual dysfunction and urine abnormality. Overdosage Human experience of acute overdose with Avifix is limited. There is no dermatitis,

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specific antidote for overdose with Avifix. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. Since Nelfinavir is highly protein bound, dialysis is unlikely to significantly remove the drug from blood. Drug Interactions Nelfinavir is an inhibitor of CYP3A (cytochrome P450 3A). Coadministration of Avifix and drugs primarily metabolized by CYP3A (e.g., dihydropyridine calcium channel blockers) may result in increased plasma concentrations of the other drug that could increase or prolong both its therapeutic and adverse effects. Co-administration of drugs that inhibit CYP3A may increase Nelfinavir plasma concentration.
Drugs that Should not be Co-administered with Avifix

Class
Antiarrhythmics Antihistamines Antimigraine Antimycobacterial agents Benzodiazepines Gastrointestinal motility agents

Drug
Amiodarone, Quinidine Astemizole, Terfenadine Ergot derivatives Rifampin Midazolam, Triazolam Cisapride

Drugs which Require a Dose Reduction when Co-administered with Avifix

Class
Antimycobacterial agents

Drug
Rifabutin

Based on known metabolic profiles, clinically significant drug interactions are not expected between Avifix and Dapsone, Trimethoprim/Sulfamethoxazole, Clarithromycin, Erythromycin, Itraconazole or Fluconazole. Anti-HIV Protease Inhibitors Indinavir : Co-administration of Indinavir with Nelfinavir resulted in an 83% increase in Nelfinavir plasma AUC and a 51% increase in Indinavir plasma antioxidant capacity (AC). Currently, there are no safety and efficacy data available from the use of this combination.

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Other Potentially Clinically Significant Drug Interactions with Avifix * Anticonvulsants : Carbamazepine May decrease Nelfinavir plasma concentrations** May increase Nelfinavir plasma concentrations Plasma concentrations may be decreased by Avifix

Anti-HIV protease inhibitors : Indinavir Oral contraceptives : Ethinyloestradiol

* This table is not all inclusive ** Avifix may not be effective due to decreased Nelfinavir plasma concentrations in patients taking these agents concomitantly

Ritonavir : Co-administration of Ritonavir with Avifix resulted in a 152% increase in Nelfinavir plasma (area under the plasma concentration x time curve) AUC and very little change in Ritonavir plasma AC. Currently, there are no safety and efficacy data available from the use of this combination. Saquinavir : Co-administration of Saquinavir (using an experimental softgelatin capsule formulation of Saquinavir 1200 mg) with Avifix resulted in an 18% increase in Nelfinavir plasma AUC and a 4-fold increase in Saquinavir plasma AC. If used in combination with Saquinavir hard gelatin capsules at the recommended dose of 600 mg tid, no dose adjustments are needed. Currently, there are no safety and efficacy data available from the use of this combination with antifungal agents. Anti-HIV Reverse Transcriptase Inhibitors Didanosine : It is recommended that Didanosine be administered on an empty stomach; therefore, Nelfinavir should be administered (with food) one hour after or more than two hours before Didanosine. Zidovudine : Co-administration of Zidovudine and Lamivudine with Avifix resulted in a 35% decrease in Zidovudine plasma AC. A dose adjustment is not needed when Zidovudine is administered with Avifix. Little or no change in the pharmacokinetics of either drug was observed when Avifix was co-administered with Lamivudine or Stavudine.

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Pharmaceutical Precautions Store below 30 C in a dry place. Keep out of reach of children. Commercial Pack Avifix Tablet : Each box contains 1 x 10s tablets in blister strip. Each tablet contains Nelfinavir Mesylate INN equivalent to 250 mg Nelfinavir.

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Avilam
Tablet Description Avilam(formerly known as 3TC) is the brand name for Lamivudine, a synthetic nucleoside analogue with activity against HIV. Indications Avilamin combination with Zidovudine is indicated for the treatment of HIV infection. Dosage and Administration Adults and Adolescents (12 to 16 years) : The recommended oral dose of Avilam for adults and adolescents is 150 mg twice daily administered in combination with Zidovudine. For adults with low body weights (less than 50 kg or 110 lb), the recommended oral dose of Avilam is 2 mg/kg twice daily administered in combination with Zidovudine. No data are available to support a dosage recommendation for adolescents with low body weight (less than 50 kg). Paediatric Patients : The recommended oral dose of Avilam for paediatric patients of age between 3 months to up to 12 years is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day) administered in combination with Zidovudine. Dose Adjustment It is recommended that doses of Avilam be adjusted in accordance with renal function in patients older than age 16 years (see following table). Insufficient data are available to recommend a dosage of Avilam in patients undergoing dialysis. Contraindication Avilam is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product. Warning and Precautions In paediatric patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis, the combination of 64

Table : Adjustment of Dosage of Avilam in Accordance with Creatinine Clearance Creatinine Clearance (mL/min) >50 30-49 15-29 5-14 <5 Recommended Dosage of Avilam 150 mg twice daily 150 mg once daily 150 mg first dose, then 100 mg once daily 150 mg first dose, then 50 mg once daily 50 mg first dose, then 25 mg once daily

Avilam and Zidovudine should be used with extreme caution and only if there is no satisfactory alternative therapy. Treatment with Avilam should be stopped immediately if there are clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including Lamivudine. A majority of these cases have been in women. Caution should be exercised when administering Avilam to any patient, and particularly to those with known risk factors for liver disease. Treatment with Avilam should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity. Reduction of the dosage of Avilam is recommended for patients with impaired renal function. In clinical trials and postmarketing experience, some patients with HIV infection who have chronic liver disease due to hepatitis B virus infection experienced clinical or laboratory evidence of recurrent hepatitis upon discontinuation of Lamivudine. Consequences may be more severe in patients with decompensated liver disease. Use in Pregnancy and Lactation Animal reproductive toxicity studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Lamivudine should be used during pregnancy only if the potential benefits outweigh the risks. The US Public Health Service Centers for Disease Control and Prevention recommend that HIVinfected mothers should not breast feed their infants to avoid the risk of postnatal transmission of HIV infection. 65

Side Effects Adults : Selected clinical adverse events with a >5% frequency during therapy with Lamivudine 150 mg bid plus Zidovudine 200 mg tid compared with Zidovudine are listed in the following table.
Selected Clinical Adverse Events (>5% Frequency) in Four Controlled Clinical Trials Adverse Event Lamivudine 150 mg bid plus Zidovudine (n = 251)
35 % 27 % 10 % 33 % 18 % 10% 9% 6% 5% 12% 11% 10% 9% 20% 18% 9% 12% 8% 5%

Zidovudine (n = 230)

General Headache Malaise and fatigue Fever or chills Digestive Nausea and vomiting Diarrhoea Anorexia and/or decreased appetite Abdominal pain Abdominal cramps Dyspepsia Nervous system Neuropathy Insomnia and other sleep disorders Dizziness Depressive disorders Respiratory Nasal signs and symptoms Cough Skin Skin rashes Musculoskeletal Musculoskeletal pain Myalgia Arthralgia

27 % 23 % 12 % 29% 22% 7% 11% 3% 5% 10% 7% 4% 4% 11% 13% 6% 10% 6% 5%

Observed During Clinical Practice : The events identified during use of the drug in clinical practice include alopecia, anaphylaxis, hyperglycaemia, lactic acidosis and hepatic steatosis, peripheral neuropathy, pruritus, rash, urticaria, and weakness.

Overdosage There is no known antidote for Lamivudine. It is not known whether Lamivudine can be removed by peritoneal dialysis or haemodialysis.

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Pharmaceutical Precautions Store in a cool dry place. Protect from light. Keep out of reach of children. Commercial Pack Avilam Tablet : Each box contains 1 x 10s tablets in blister strip. Each tablet contains Lamivudine INN 150 mg.

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Avitron V
Tablet

Description Avitron V tablet contains Vitamin B1 or Thiamine Hydrochloride USP. Thiamine Hydrochloride is a water soluble vitamin belongs to vitamin Bcomplex family. Thiamine in the form of Thiamine Pyrophosphate (also known as cocarboxylase), is the co-enzyme for decarboxylation of -keto acids. Thiamine pyrophosphate also acts as the co-enzyme of transketolase in the direct oxidation pathway of glucose metabolism. In thiamine deficiency, pyruvic acid and lactic acid accumulate in tissues. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. Thiamine is not stored in the body, intracellular thiamine is present almost entirely as the co-enzyme moiety of active enzymes. Thiamine requirement is related to carbohydrate intake and the metabolic rate. A daily intake of 400 mg thiamine per 1000 kcal is recommended. The total requirement increases during periods of active growth or heavy physical labour, during pregnancy and lactation, in pathological conditions such as fever and hyperthyroidism and in other conditions causing increased metabolism. Indications Avitron V is indicated in the treatment of the various manifestations of thiamine deficiency such as beriberi (wet or dry) and Wernicke's encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary thiamine may be indicated prophylactically in conditions where there is low dietary intake or low gastrointestinal absorption of thiamine, and increased thiamine requirement periods e.g. - active growth - heavy physical labour - pregnancy and lactation - in pathological conditions such as fever and hyperthyroidism and other conditions causing increased metabolism.

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Dosage and Administration Mild chronic deficiency : 10-25 mg daily Severe deficiency : 200-300 mg daily or as advised by the physician Contraindication Thiamine is contraindicated in patients with known hypersensitivity to it. Side Effects Vitamin B1 does not have adverse effects when given orally. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness etc. may occur. Pregnancy and Lactation Thiamine is safe in pregnant women and recommended for the treatment of neuritis in pregnancy. Although it is not known if thiamine is excreted in breast milk, the drug may be taken safely during lactation. Pharmaceutical Precaution Store in a cool and dry place, protected from light. Commercial Pack Avitron V Tablet : Box containing 25 blister strips of 10 tablets. Each tablet contains Thiamine Hydrochloride USP 100 mg.

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Axodin
Tablet

Description Axodin (Fexofenadine), a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H1 receptor antagonist activity. Fexofenadine Hydrochloride is rapidly absorbed into the body following oral administration, with T max occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/ml and 494 ng/ml following the administration of a 120 mg and 180 mg dose (once daily) respectively. Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism, as it was the only major compound identified in urine and faeces of animal and human. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 16 hours after multiple dosing. The single and multiple dose pharmacokinetics of Fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine. Indications Axodin is indicated for the relief of symptoms associated with allergic rhinitis and allergic skin conditions e.g. chronic urticaria. Dosage and Administration Allergic rhinitis Children 6 to 11 years The recommended dose of Fexofenadine Hydrochloride is 30 mg twice daily. Adults and children aged 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults and children aged 12 years and over is 120 mg once daily. 70

Allergic skin conditions, e.g. chronic urticaria Children 6 to 11 years The recommended dose of Fexofenadine Hydrochloride is 30 mg twice daily. Adults and children 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults and children aged 12 years and over is 180 mg once daily. Children under 6 years of age The efficacy and safety of Fexofenadine Hydrochloride has not been studied in children under 6.

Use in Special Risk Group Studies in special risk groups (elderly and patients with renal or hepatic impairment) indicate that it is not necessary to adjust the dose of Fexofenadine Hydrochloride in these patients. Contraindication The product is contraindicated in patients with known hypersensitivity to any of its ingredients. Drug Interactions Fexofenadine does not undergo hepatic bio-transformation and is therefore unlikely to interact with drugs that rely upon hepatic metabolism. Fexofenadine Hydrochloride at doses of 120 mg twice daily has been safely co-administered with Erythromycin (500 mg three times daily) and Ketoconazole (400 mg once daily) under steady state conditions in healthy volunteers. A two fold increase in the level of plasma Fexofenadine was observed after co-administration of Erythromycin or Ketoconazole but this was not associated with any increase in adverse event or effects on the QT interval, compared to that seen when the drugs were given alone. Animal studies have shown that the increase in plasma level of Fexofenadine observed after co-administration of Erythromycin or Ketoconazole appears to be due to an increase in gastrointestinal absorption.

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Side Effects In placebo-controlled trials, adverse events were comparable in Fexofenadine and placebo treated patients. Adverse events reported with Fexofenadine includeCommon : headache, Uncommon : fatigue, drowsiness, nausea, tachycardia, palpitations, dry mouth, dyspepsia and gastrointestinal disturbances (including diarrhoea), Rare : taste, disturbances, anaphylactic reactions, dyspnoea, chest tightness, increased hair loss/hair thinning, photosensitivity, dysmenorrhoea, menstrual disorders, Others : As with other non-sedating antihistamines, dizziness, nervousness, agitation, sleep disorders, insomnia or paroniria may infrequently be reported by patients. The incidence of such reports under Fexofenadine was similar to the incidence under placebo. Effects on ability to Drive and Use Machines On the basis of the pharmacodynamics profile and reported adverse events it is unlikely that Fexofenadine Hydrochloride will produce an effect on the ability to drive or use machines. In objective tests, Fexofenadine Hydrochloride has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. Overdosage Most reports of Fexofenadine Hydrochloride overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Single doses up to 800 mg and doses up to 690 mg bid for 1 month or 240 mg qid for 1 year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo. Use in Pregnancy and Lactation Fexofenadine should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus. There are no data on the content of human milk after administering Fexofenadine Hydrochloride. However, when Terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore Fexofenadine is not recommended for mothers breast feeding their babies.

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Pharmaceutical Precautions Store in cool and dry place. Keep away from children. Commercial Pack Axodin 60 Tablet : Each tablet contains Fexofenadine Hydrochloride 60 mg in 10 x 5 blister strips. Axodin 120 Tablet : Each tablet contains Fexofenadine Hydrochloride 120 mg in 10 x 5 blister strips. Axodin 180 Tablet : Each tablet contains Fexofenadine Hydrochloride 180 mg in 10 x 3 blister strips.

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Azithrocin
Capsule/Tablet/Suspension

Description Azithrocin contains Azithromycin USP. It is an azalide antibiotic active against Gram-positive and Gram-negative organisms. Azithromycin interferes with ribosome function in susceptible bacteria by inhibiting the translocation of peptides. Indications Azithrocin (Azithromycin) is indicated for infections caused by susceptible organisms, in upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis, in lower respiratory tract infections including bronchitis and pneumonia, skin and soft tissue infections, and otitis media. Azithrocin is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. Dosage and Administration Adult : Azithrocin should be given as 500 mg once-daily orally for 3 days or as an alternative, given over 5 days with 500 mg on day 1, then 250 mg on days 2-5. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 g given as a single dose. Normal adult dose is recommended for elderly patients. For children over 6 months recommended dose is 10 mg/kg once daily for 3 days; or if body weight is 15-25 kg : 200 mg once daily for 3 days, if body weight is 26-35 kg : 300 mg once daily for 3 days, if body weight is 36-45 kg : 400 mg once daily for 3 days. As common with many other antibiotics, Azithrocin should be taken at least 1 hour before or 2 hours after meal and antacid.

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Contraindication Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases. Side Effects Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects were mild to moderate in nature and of gastrointestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhoea. Allergic reactions such as rash have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to Azithromycin has not been established. Precautions As with any antibiotic, observation for signs of superinfection with nonsusceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment. Use in Pregnancy and Lactation Animal reproduction studies have demonstrated that Azithromycin crosses the placenta, but have revealed no evidence of harm to the foetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. No data on secretion of Azithromycin in breast milk is available, so, Azithromycin should only be used in lactating mothers where adequate alternatives are not available. Drug Interactions Azithromycin absorption is reduced in presence of food and antacid. So, Azithromycin should be administered 1 hour before or 2 hours after taking food or antacid. In patients receiving ergot alkaloids, Azithromycin should be avoided concurrently because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P450 75

system. However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of Digoxin and Cyclosporin. Therefore, if co-administration is necessary, caution should be exercised and serum level of Digoxin and Cyclosporin should be checked. There have been no pharmacokinetic drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone and Cimetidine. Overdosage There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated. Commercial Pack Azithrocin Capsule : Box containing 1 x 10s blister strip, each capsule contains Azithromycin USP equivalent to 250 mg anhydrous Azithromycin. Azithrocin 500 Tablet : Box containing 1 x 3s blister strip, each film coated tablet contains Azithromycin USP equivalent to 500 mg anhydrous Azithromycin. Azithrocin Suspension : Dry powder in glass bottle for reconstitution into 15 ml of suspension. After reconstitution each 5 ml contains Azithromycin USP equivalent to 200 mg anhydrous Azithromycin.

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Azmasol
Inhaler

Description Salbutamol BP, the active ingredient of Azmasol Inhaler, is a 2 adrenoceptor agonist used in the treatment of asthma and other forms of diffuse reversible airways obstruction. Indications Azmasol (Salbutamol) inhaler is indicated for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema. Azmasol inhaler may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-inducedasthma. It is suitable for treating bronchospasm in patients with coexisting heart disease or hypertension, including those taking blockers, because of its selective action on the bronchial receptors and lack of effects on the cardiovascular system. Salbutamol is a sympathomimetic agent which has a highly selective action on adrenergic receptors in bronchial muscle. At therapeutic levels, it has little effect on cardiac receptors. Dosage and Administration Adults i) For the relief of acute bronchospasm and for managing intermittent episodes of asthma : one or two inhalation as a single dose ii) For chronic maintenance or prophylactic therapy : two inhalations three or four times daily iii) For prevention of exercise induced bronchospasm : two inhalations before exertion. Children For relief of acute bronchospasm, management of episodic asthma and for prevention of exercise induced bronchospasm : one inhalation; for routine maintenance and prophylaxis : one inhalation three or four times daily, increasing if necessary to two inhalations three or four times daily. 77

Elderly The dosage is the same as that for adults. Contraindication Although intravenous Salbutamol, and occasionally Salbutamol tablets, are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, Salbutamol inhaler preparations are not appropriate for managing premature labour. Salbutamol preparation should not be used for threatened abortion during the first or second trimesters of pregnancy. Salbutamol inhaler is contraindicated in patients with a history of hypersensitivity to any of its components. Precautions In the event of previously effective dose of Salbutamol inhaler failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted. Side Effects Mild tremor and headache have been rarely reported. These usually disappear with continuous treatment. There have been very rare reports of transient muscle cramp. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. Pharmaceutical Precaution Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30C. Keep away from eyes. Keep away from children.

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Commercial Pack Azmasol Inhaler : Each canister contains 200 measured doses, each containing 100 g of Salbutamol BP. Azmasol Refill Can : Each canister contains 200 measured doses, each containing 100 g of Salbutamol BP.

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Bexidal
Tablet

Description Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC. Indications Allergic diseases or symptoms, such as urticaria, pruritus of various origin, eczema, drug rash, allergic conjunctivitis, dermatitis of nutritional origin, hay fever, vasomotor rhinitis, allergic asthma. Dosage and Administration Unless otherwise prescribed, the following doses are recommended: Adults and children over 10 years .................. 2-6 tablets daily Children from 5-10 years ............................. 2-4 tablets daily Children from 2-5 years ............................ 1-3 tablets daily Children up to 2 years ................................. 1-2 tablets daily Treatment should be given in several single doses daily. Bexidal may be swallowed during or shortly after meals. For children, the tablets may be crushed and mixed with food. Bexidal is essentially free from secondary sedative-hypnotic effects. It does not impair psycho-physical efficiency to any appreciable degree. Contraindication Caution is required while driving or operating heavy machinery Concomitant use of CNS depressant or alcohol Patients to whom Mebhydrolin has previously been suspected to have agranulocytosis or neutropenia First trimester of pregnancy Commercial Pack Bexidal Tablet : Box containing 20 aluminium strips of 10 tablets. Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC. 80

Bexitrol-F
Inhaler

Description Bexitrol-F metered dose inhaler is a combination of Salmeterol Xinafoate INN and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective, long acting 2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose. Indications Bexitrol-F is indicated in the regular treatment of asthma where use of a combination product (long-acting 2 agonist and inhaled corticosteroid) is appropriate. Other indication of Bexitrol-F is patients with frequent asthmatic episodes requiring bronchodilators or those with asthmatic episodes at night. Pharmacodynamic Properties Mechanism of action : Bexitrol-F contains Salmeterol and Fluticasone Propionate, which have different modes of action. Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. Bexitrol-F can offer a more convenient regime for patients on concurrent -agonist and inhaled corticosteroid therapy. The mechanisms of action of both drugs are discussed below: Salmeterol : Salmeterol is a selective long-acting (12 hour) 2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor. Fluticasone Propionate : Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically.

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Recommended Doses Adults and adolescents 12 years and olderThe recommended dose is two puffs of Bexitrol-F twice daily or as prescribed by the physicians. Contraindication Bexitrol-F is contraindicated in patients with a history of hypersensitivity to any of the ingredients of the product. Special Warning and Precautions Consideration should be given to additional corticosteroid therapies, and administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, Bexitrol-F should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Bexitrol-F should be administered with caution in patients with thyrotoxicosis. Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown. Drug Interactions Both non-selective and selective -blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when coadministering known strong CYP3A4 (cytocrome P450 3A4) inhibitors (e.g. Ketoconazole, Ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate. Use in Pregnancy and Lactation There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk. Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.

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Side Effects As Bexitrol-F contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below. Salmeterol : The pharmacological side effects of 2 agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduced with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of oropharyngeal irritation, arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been rare reports of muscle cramps. Fluticasone Propionate : Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Bexitrol-F Inhaler. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Overdosage There are no data available from clinical trials on overdosage with this combination drug. Pharmaceutical Precaution Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30o C. Keep away from eyes. Keep away from children. Commercial Pack Bexitrol-F Inhaler : Each canister contains 120 metered doses, each containing Salmeterol Xinafoate INN equivalent to 25 g Salmeterol and Fluticasone Propionate BP 250 g.

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Bexitrol
Inhaler

Description Salmeterol Xinafoate INN, the active ingredient of Bexitrol Inhaler, is a selective, long acting -agonist used in the treatment of asthma and 2 other forms of diffuse airways obstruction. Bexitrol Inhaler is a metered dose aerosol unit containing a micro-crystalline suspension of Salmeterol in a mixture of propellant with lecithin. Indications Bexitrol (Salmeterol) is a long-acting 2-agonist which is considerably more potent, selective and long-acting compared with traditionally used bronchodilators. Bexitrol protects against asthma induced by histamine or methacholine for a period of at least 12 hours in adults and children. Furthermore, long-acting -agonist show a more than 4-fold greater 2 potency than short-acting agents (for example, Salbutamol) against histamine-induced bronchoconstriction. Bexitrol has the potential to improve the treatment of patients with asthma; the drug provides prolonged bronchodilation and decrease asthma symptoms and the need for short acting 2-agonist, independently of concomitant steroid use. Studies have consistently reported improved control of nocturnal asthma with long-acting -agonist compared with other anti-asthma drugs. 2 Bexitrol is indicated for the long term regular treatment of reversible airways obstruction (including nocturnal and exercise-induced asthma) and chronic bronchitis. In paediatric asthma, the use of Bexitrol may avoid exposure of children to Theophylline or high-dose corticosteroids, with their attendant risks. Dosage and Administration The recommended dose is 50 g (2 puffs) twice daily, although in severe disease the dose may be increased to 100 g twice daily. The drug should not be used on an as required basis, although on account of its efficacy in nocturnal and exercise induced asthma, single dose administration may be considered as a treatment option.

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Contraindication Patients with thyrotoxicosis. Special caution should be exercised in patients with cardiac problems predisposing to arrythmias. The drug is ineffective in patients taking non-selective -blocking drugs. Precautions Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attack or even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in these patients. Increasing use of bronchodilators, in particular short-acting inhaled -agonist to relieve 2 symptoms indicates deterioration of asthma control. If patients find that short acting bronchodilator treatment becomes less effective or they need more inhalation than usual, medical attention must be sought. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroids). Severe exacerbation of asthma must be treated in the normal way. Salmeterol inhaler is not designed to relieve acute asthmatic symptoms, for which an inhaled short -acting bronchodilator is required. Patients should be advised to have such rescue medication available. Potentially serious hypokalaemia may result from 2-agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics. It is recommended that serum potassium levels are monitored in such situations. Side Effects No severe irreversible adverse effect is known although systemic 2 agonist effects of Salmeterol may last up to 12 hours. Inhaled dose of Salmeterol up to 400 g given to healthy volunteers produced significant systemic side effects, the majority of which were pharmacologically predictable. Response observed with 100 g Salmeterol were similar to those observed with 400 g Salmeterol. Hypokalaemia, tremor and palpitations may all occur but only at doses of Salmeterol exceeding that recommended.

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Pharmaceutical Precaution Store below 30C, keep out of the reach of children. Commercial Pack Bexitrol Inhaler : Each canister contains 200 metered doses, each containing Salmeterol Xinafoate INN equivalent to 25 g Salmeterol.

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Bextrum
Tablet

Description Bextrum is a special formulation comprising of important vitamins, antioxidants and minerals. Each film-coated tablet contains: Vitamin A Vitamin E Vitamin K Vitamin C Thiamine Mononitrate Riboflavin Folic Acid Niacin Pantothenic Acid Pyridoxine Hydrochloride Iron Zinc Copper Manganese Iodine Selenium Molybdenum Chromium Inositol Quercetin 2700 IU 30 IU 65.00 g 120.00 mg 3.40 mg 3.40 mg 800 g 40.00 mg 20.00 mg 10.00 mg 30.00 mg 25.00 mg 2.00 mg 1.20 g 175.00 g 12.50 g 25.00 g 25.00 g 50.00 mg 54.00 g

Indications Bextrum is a once-daily tablet indicated for use to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. This preparation can also be beneficial in improving the nutritional status of women prior to conception. Bextrum tablet maintains a healthy body and active lifestyle and keeps nutrition covered for all. Dosage and Administration Bextrum may be administered once daily or as indicated by the physician. 87

Contraindication Bextrum is contraindicated in patients with a known hypersensitivity to any of the ingredients. Side Effects Generally well tolerated. Precautions Long-term intake of high levels of vitamin A (excluding that source from carotene) may increase the risk of osteoporosis in postmenopausal women. Drug Interactions No drug interactions have been reported. Use in Pregnancy and Lactation Bextrum is recommended in pregnancy and lactation. Pharmaceutical Precaution Tablets should be stored below 25 oC and protected from light and moisture. Commercial Pack Bextrum Tablet : Plastic bottle containing 30 tablets. Each tablet contains multivitamin and multimineral.

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Bronkolax
Tablet/Syrup

Description Bronkolax (Salbutamol) is a synthetic sympathomimetic agent having 2adrenergic activity and selective action on receptors of bronchial smooth muscle. It is used for the treatment of reversible obstruction of the airways. Indications Bronkolax is indicated for the relief of bronchospasm in bronchial asthma, bronchitis, emphysema and also in bronchospasm where heart disease or hypertension is co-existing. Dosage and Administration Adults Recommended dose is 2-4 mg, 3-4 times daily; in some patients higher doses up to 8 mg may be given. Children Recommended dose for age group2-6 years : 1 mg, 3-4 times daily 6-12 years : 2 mg, 3-4 times daily Over 12 years : 2-4 mg, 3-4 times daily Contraindication It should not be prescribed with blocking drugs. Bronkolax should not be used for prevention of premature labour associated with toxemia of pregnancy or antepartum hemorrhage or for threatened abortion during the first and second trimester of pregnancy. Precautions Bronkolax should be given with caution to hypersusceptible patients or those with hyperthyroidism, in patients with diabetes mellitus, serious cardiovascular disorders or hypertension. In asthmatic patients, whose condition deteriorates despite Salbutamol therapy, alternative or additional therapy including corticosteroids should be instituted 89

promptly. Adverse metabolic effects of high doses of Salbutamol may be exacerbated by concomitant administration of high doses of corticosteroids. Hypokalemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias. Concomitant administration of Aminophylline may enhance the effects of Salbutamol. Long term treatment may increase the risk of dental caries and hence adequate dental hygiene should be maintained. Side Effects Salbutamol may cause fine tremor of skeletal muscle (particularly the hands), palpitations, and muscle cramps. Slight tachycardia, headache, and peripheral vasodilation have been reported after large doses. Salbutamol may cause hypokalemia and hypoglycaemia. Sometimes hypersensitivity reactions including paradoxical bronchospasm, urticaria and angioedema may occur. Treatment of Overdosage The preferred antidote for overdosage with Salbutamol is a cardioselective beta blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm. Commercial Pack Bronkolax-2 Tablet : Box containing 100 tablet in 10 x 10s blister strips, each contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol. Bronkolax-4 Tablet : Box containing 100 tablet in 10 x 10s blister strips, each contains Salbutamol Sulphate BP equivalent to 4 mg Salbutamol. Bronkolax Syrup : 100 ml in glass bottle, each 5 ml contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.

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Cardopril
Tablet Description Cardopril (Captopril) is the first of a new class of antihypertensive agents, a highly specific competitive inhibitor of angiotensin I converting enzyme. Cardopril is available in 25 mg and 50 mg, as double scored tablets for oral administration. Indications Hypertension : Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.

Severe hypertension : Where standard therapy has failed.

Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.

Congestive heart failure : It is also used as an adjunct to the treatment of severe congestive heart failure.

Dosage and Administration Hypertension : Treatment with Cardopril should be at the lowest effective dose, which should be titrated according to the need of the patient. Mild to moderate hypertension- In mild to moderate hypertension Cardopril therapy should be used as an adjunct to thiazide therapy. Starting dose is 12.5 mg twice daily. The usual maintenance dose is 25 mg twice daily. Severe hypertension- Starting dose is 12.5 mg twice daily and can be increased incrementally to a maximum of 50 mg thrice daily.

Heart failure : In congestive heart failure an initial dose of 6.25 mg to 12.5 mg is given under close medical supervision.

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The usual maintenance dose is 25 mg thrice daily and should not exceed 50 mg thrice daily. Side Effects Haematological : neutropenia, anaemia and thrombocytopenia. Renal : proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis. Cardiovascular : hypotension, tachycardia. Skin : rashes usually pruritic, may occur. Gastrointestinal : Reversible and usually self limiting taste impairment has been reported. Stomatitis resembling aphthous ulcers has also been reported. Drug Interactions Diuretics: Diuretics potentiate the antihypertensive effect of Captopril. Potassium sparing diuretics (Triamterene, Amiloride and Spironolactone) or potassium supplements may cause significant increase in serum potassium.

Vasodilators: Captopril has been reported to act synergistically with peripheral vasodilators such as Minoxidil. Non-steroidal anti-inflammatory agents: Concomitant therapy with Indomethacin and possibly other anti-inflammatory drugs may reduce the antihypertensive effect of Captopril. Others: Caution should be exercised in prescribing Captopril for patients receiving concomitant therapy with immuno-suppressant, procainamide, allopurinol and other drugs known to cause neutropenia especially in patients with impaired renal function.

Contraindication A history of previous hypersensitivity to Captopril.

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Precautions Captopril should be used with great caution in patients with impaired renal function particularly if reno-vascular disease is present or suspected and in patient with collagen vascular disorders such as systemic lupus erythematosus or scleroderma. Captopril should not be used during pregnancy. Commercial Pack Cardopril-25 Tablet : Box containing 100 tablets in 10 x 10s blister strip, each tablet contains 25 mg of Captopril USP. Cardopril-50 Tablet : Box containing 100 tablets in 10 x 10s blister strip, each tablet contains 50 mg of Captopril USP.

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Carocet
Tablet

Description Carocet is a chewable tablet which contains a combination of three antioxidant vitamins. Each tablet contains Carotene (pharma grade) 6 mg, Ascorbic Acid USP and Sodium Ascorbate USP equivalent to Ascorbic Acid (Vitamin C) 200 mg and Vitamin E preparation USP equivalent to dl-alpha-Tocopheryl Acetate (Vitamin E) 50 mg. Indications Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows: -carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E1, B- and T-lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with -carotene and vitamin C. Moreover, vitamin E is essential to protect us against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body. Dosage and Administration Dosage varies according to individuals need. The usual recommended dose is two tablets daily or as advised by the physician. The dose can be increased up to four tablets daily. Side Effects carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterized by a yellowish 94

colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids. Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation. Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure. Contraindication There is no absolute contraindication. Warning and Precautions There are some evidences that -carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs. Use in Pregnancy and Lactation carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women. Drug Interactions Cholestyramine, Colestipol, Neomycin cause decreased absorption of carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of certain drugs including oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug-induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K. Overdosage No cases have been reported. Commercial Pack Carocet Tablet : Bottle containing 20 tablets. 95

Carofol-Z
Capsule

Description Carofol-Z capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.50 mg and Zinc Sulphate Monohydrate USP 61.80 mg. Most ordinary iron products contain iron salts that may cause gastric irritation. But Carofol-Z capsule contains pure iron micro particles called carbonyl iron. This advanced formula is specially designed to be well absorbed, gentle on the stomach and offers enhanced safety in case of an accidental overdose. Folic Acid and Zinc supplementation are also important during pregnancy as because Folic Acid helps to prevent the risk of birth defects like neural tube defects (NTDs) and low birth weight (LBW). Zinc is an important factor to maintain a healthy immune system. Indications The capsule is indicated for the treatment of iron deficiency or iron deficiency anemia, folic acid and zinc deficiency. It is also indicated for prophylactic use when inadequate diet calls for supplementary Zinc, Folic Acid and Iron specially during pregnancy. Dosage and Administration Treatment 2 to 4 capsules a day or as prescribed by the physician. Prophylaxis Adult and elderly : Usually once daily. In severe cases, two capsules a day may be required as prescribed by the physician. Children aged over one year: One capsule a day, the capsule may be opened and the pellets may be mixed with soft, cool food but they must not be chewed. Contraindication It is contraindicated in patients with haemolytic anaemia and in condition with increased hypersensitivity to any of its components and increased body iron content. 96

Side Effects Side effects of Iron, Folic Acid and Zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea etc. The capsule is specially designed to reduce the possibility of gastrointestinal irritation. Drug Interactions Iron chelates with Tetracycline. Since oral Iron products interfere with absorption of oral Tetracycline antibiotics, these products should not be taken within hours of each other. Occasional gastrointestinal discomfort may be minimized by taking it with meals. Absorption of Iron may be impaired by concurrent administrations of Penicillamine and antacid. Overdosage Overdosage of Iron is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, vomiting may also be induced. Zinc Sulphate in gross overdosage is corrosive. Symptoms are those of gastrointestinal irritation, leading in severe cases to haemorrhagic corrosion of the mucosa and possible later stricture formation. Demulcent such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic acid have been recommended. The extended release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter measures. Precautions Care should be taken in patients who may develop Iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. In patients with renal failure, a risk of Zinc accumulation may exist. Pharmaceutical Precaution Store capsules in cool and dry place. Keep out of reach of children. Commercial Pack Carofol-Z capsule : Box containing 50 capsules in 5 x 10's blister strips. Each capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.05 mg and Zinc Sulphate Monohydrate USP 61.80 mg.

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Cephalen
Capsule/Suspension

Description Cephalen (Cefalexin) is a semisynthetic antibiotic of the cephalosporin group, intended for oral administration which has a bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Cephalen is acid stable and may be given regardless of meal. It is rapidly absorbed after oral administration and peak serum level is obtained after one hour. It is mainly excreted in the urine. Indications Cephalen is indicated for the treatment of the following infections when caused by susceptible organisms. Respiratory tract infections : Acute and chronic bronchitis and infected bronchiectasis. Genito-urinary tract infections : Acute and chronic nephritis, cystitis, urethritis and prostatitis, prophylaxis of recurrent urinary tract infections. Skin and soft tissue infections : Caused by staphylococci and/or streptococci. Ear, Nose and Throat infections : Otitis media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis. Bone infections : Caused by staphylococci and/or P. mirabilis. Dosage and Administration Adult : The usual dose is 250 mg to 500 mg every 6 hour. For skin and soft tissue infections, streptococcal pharyngitis and uncomplicated cystitis, in patients over 15 years of age, 500 mg of the drug may be administered every 12 hour. In severe or deep seated infections the dose can be increased up to 3 g to 6 g daily. Children : The dosage range is 25-100 mg/kg/day in divided doses to a maximum of 4 g daily (please note the table below ). 98

Childrens weight 10 kg ( 22 Ibs) 20 kg ( 44 Ibs) 40 kg ( 88 Ibs)

Recommended Dose 62.5 mg to 125 mg qid or 125 mg to 250 mg bid 125 mg to 250 mg qid or 250 mg to 500 mg bid 250 mg to 500 mg qid or 500 mg to 1 g bid

For streptococcal pharyngitis, skin and soft tissue infections and in patients over 1 year of age the total daily dose may be divided and administered every 12 hour. In the therapy of otitis media 75-100 mg/kg/day in four divided doses may be required. In the treatment of beta haemolytic streptococcal infections a therapeutic dosage of the drug should be given at least for 10 days. Contraindication Cephalen is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics. Side Effects Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Skin rash, angioedema, rise in serum aminotransferases, eosinophilia, neutropenia have been reported very rarely. Superinfection with resistant micro-organisms, particularly candida may follow the treatment. Precautions Cefalexin should be given with caution in patients with renal impairment. Under such condition, careful clinical observation should be made because safe dosage may be lower than the usually recommended. The urine of patients receiving Cefalexin may give a false positive reaction for glucose with copper reduction reagent. Positive results to Coombs test have been reported. Although there is no evidence of teratogenicity in animal tests, Cefalexin may be used during pregnancy when it is considered essential. Cefalexin is found in the milk of nursing mothers, hence caution should be taken when it is administered to nursing mothers. 99

Commercial Pack Cephalen-250 Capsule : Box containing 10 x 10s blister strips. Each capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 250 mg. Cephalen-500 Capsule : Box containing 5 x 10s blister strips. Each capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 500 mg. Cephalen Suspension : Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution each 5 ml contains Cefalexin BP equivalent to anhydrous Cefalexin 125 mg.

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Cerivin
Tablet

Description Cerivin (Vinpocetine) increases cerebral metabolism: it increases the glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels. Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte derformability; it also promotes O 2 transport into the tissues by reducing the O 2 affinity of erythrocytes. It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance), it does not elicit steal phenomenon, on the contrary, it primarily improves the blood supply of the injured, ischaemic area while it remains unchanged in the intact areas (inverse steal effect), it further increases blood flow which is already increased as a result of hypoxia. Indications All forms of acute and chronic cerebral circulatory insufficiency: TIA (Transient Ischaemic Attack), reversible ischaemic neurological deficiency, progressive stroke, completed stroke, post-apoplectic conditions, multiinfarct dementia, cerebral arteriosclerosis, post traumatic, hypertensive encephalopathy etc. For the reduction of psychic or neurological symptoms of cerebral insufficiency (e.g. memory disturbances, dizziness, headache, aphasia, apraxia, locomotor disorders etc.).

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Ophthalmology: It can be used for the treatment of vascular disorders of the choroid and retina due to arteriosclerosis, vasospasm, macular degeneration, arterial or venous thrombosis or embolism, and glaucoma secondary to the above mentioned disorders. Otology: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin, presbyacusis, Menieres disease, cochleovestibular neuritis, tinnitus and dizziness of labyrinth origin. For the treatment of vasovegetative symptoms of climacteric syndrome. Dosage and Administration Cerivin is taken 1-2 tablets three times daily with meals. The maintenance dose is 1 tablet three times daily over long periods. Side Effects Cerivin is well tolerated. In some cases transient fall of blood pressure and tachycardia may occur. Contraindication Cerivin is contraindicated in pregnancy and lactation. Precautions Because Cerivin can reduce the ability of blood to clot, those individuals with a tendency to bleed should avoid Vinpocetine. Drug Interactions Slight changes in prothrombin time have been noted in those adding Vinpocetine to Warfarin dosing. The changes appear minimal. There are no other interactions reported so far. Therefore, it can be applied in combinations. Commercial Pack Cerivin Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each tablet contains Vinpocetine INN 5 mg.

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Clobex
Capsule/Syrup

Description Clobex (Cloxacillin) is a beta-lactamase resistant antibacterial agent with bactericidal activity against most Gram-positive organisms and Neisseria spp. It is also effective against beta-lactamase producing Gram-negative organisms when given with Ampicillin. Indications Clobex is indicated for the treatment of infections caused by Grampositive organisms including infections caused by beta-lactamase producing Staphylococci such as :
Skin and soft tissue infections : Boils, Abscesses, Carbuncles,

Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis media and externa, Protection of skin graft and Skin infections like ulcer, eczema, acne, etc.
Respiratory tract infections : Pneumonia, Lung abscess, Empyema,

Sinusitis, Pharyngitis and Tonsillitis.

Other infections caused by sensitive organisms : Osteomyelitis,

Enteritis, Endocarditis, Urinary tract infection, Meningitis and Septicaemia.

Dosage and Administration Adult : Usual dose is 500 mg 6 hourly daily Children (2-10 years) Children (up to 2 years) : 250 mg 6 hourly daily : 125 mg (i.e. 1 measuring spoonful of Clobex Syrup) 6 hourly daily

Dose may be doubled in severe infection and should be taken at least 30 minutes before food. 103

Contraindication Clobex should not be given to patients known to be hypersensitive to penicillin. Precautions Clobex should be given with caution to patients with known history of allergy. Side Effects Common side effects are skin rash, transient diarrhoea, nausea, heartburn, pruritus and disturbance of blood electrolyte. Rarely anaphylactic shock. Commercial Pack Clobex Capsule : Box containing 100 capsules in 10 x 10s foil strips, each capsule containing Cloxacillin Sodium BP equivalent to 500 mg Cloxacillin. Clobex Syrup : Dry powder in glass bottle for reconstitution into 100 ml syrup. After reconstitution each 5 ml contains Cloxacillin Sodium BP equivalent to 125 mg Cloxacillin.

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Cosmotrin
Cream

Description Cosmotrin cream is a topical anti-acne preparation containing Tretinoin USP 0.025%. Each gram Cosmotrin cream contains Tretinoin USP 0.25 mg. Pharmacology Although the exact mode of action of Tretinoin is unknown, but current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules. Indications For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate. Dosage and Application Cosmotrin cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturisers and cosmetics may be used during treatment with Cosmotrin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided. Contraindication Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer). Use in Pregnancy and Lactation There is an inadequate evidence of the safety of topically applied Tretinoin cream during pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So, the cream should not be used during pregnancy and lactation. 105

Side Effects Initial external application of Tretinoin generally may cause burning or slight irritation. Erythema and peeling at the site of application. If irritation becomes severe and persists, discontinue application and consult physician, if necessary. Drug Interactions Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days. Precautions Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or other mucous membrane. If contact in these areas occur, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin. Pharmaceutical Precaution Keep out of the reach of children. Keep in a cool and dry place, protect from light. Commercial Pack Cosmotrin Cream : Tube containing 10 g cream, each gram contains Tretinoin USP 0.25 mg.

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Cox B
Capsule

Description Cox B (Celecoxib) is a selective cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme. Indications For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of rheumatoid arthritis. For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP). Dosage and Administration Osteoarthritis : The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily. Rheumatoid arthritis : The recommended oral dose is 100 to 200 mg twice daily. Familial adenomatous polyposis (FAP) : Usual medical care for FAP patients should be continued while on Cox B. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2 x 200 mg capsules) twice daily to be taken with food. Contraindication Cox B is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic-type reactions to Sulfonamides (Celecoxib contains a sulfonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic-type reactions after taking Aspirin or other 107

NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Adverse Reactions Adverse events occurring in 2% of patients at recommended doses- Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patientsGeneral : Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalized, face oedema, fatigue, fever, hot flushes, influenzalike symptoms, pain, peripheral pain. Gastrointestinal : Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting. Cardiovascular : Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction. Nervous system : Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis. Male reproductive system : Prostatic disorder. Resistance mechanism disorders : Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media. Hearing and vestibular : Deafness, ear abnormality, earache, tinnitus.

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Heart rate and rhythm : Palpitation, tachycardia. Respiratory : Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia. Liver and biliary system : Peptic function abnormal, increased AST and ALT. Musculoskeletal : Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis. Urinary system : Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection. Metabolic and nutritional : Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Body weight is also increased. Psychiatric : Anorexia, anxiety, increased appetite, depression, nervousness, somnolence. Haemic : Anaemia, ecchymosis, epistaxis, thrombocythaemia. Skin and appendages : Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria. Application site disorders : Cellulitis, contact dermatitis, skin nodule. Special senses : Taste perversion. Vision : Blurred vision, cataract, conjunctivitis, eye pain, glaucoma. Use in Special Population Geriatric : Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

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Paediatric : The safety and efficacy of Celecoxib is not established in paediatric patients. Hepatic Insufficiency : Cox B capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended. Pregnancy : Cox B should be used during pregnancy only if the potential benefit justifies the potential risk of the foetus. In late pregnancy (third trimester), Celecoxib should be avoided because it may cause premature closure of the ductus arteriosis. Precautions Cox B, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food. Co-administration of Cox B with an aluminium and magnesiumcontaining antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs. Drug Interactions ACE inhibitors : Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Cox B concomitantly with ACE inhibitors. Frusemide : NSAIDs can reduce the natriuretic effect of frusemide and thiazides in some patients. Aspirin : Cox B can be used with low dose Aspirin. However, concomitant administration of Aspirin with Cox B may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Cox B alone. Fluconazole : Concomitant administration of Fluconazole at 200 mg qid resulted in a two-fold increase in Celecoxib plasma concentration. Cox B should be introduced at the lowest recommended dose in patients receiving Fluconazole. Lithium : Patients on Lithium treatment should be closely monitored when Cox B is introduced or withdrawn. Warfarin : Caution should be used when administering Cox B with Warfarin since these patients are at increased risk of bleeding complications.

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Overdosage Symptoms following NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Pharmaceutical Precaution Store at temperature between 15C and 30C. Commercial Pack Cox B-100 Capsule : Box containing 50 capsules in 5 x 10s blister strips. Each capsule contains Celecoxib INN 100 mg. Cox B-200 Capsule : Box containing 50 capsules in 5 x 10s blister strips. Each capsule contains Celecoxib INN 200 mg.

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Curin
Tablet

Description Curin tablet is a preparation of Levocetrizine Dihydrochloride. Levocetrizine is the active (levo) isomer of Cetrizine. It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1-receptors than Cetirizine. Levocetirizine has a rapid and long-lasting action, allowing once-a-day administration. Indications Curin is indicated in the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. Dosage and Administration Adults & children over 6 years of age : One Curin tablet (Levocetrizine Dihydrochloride 5 mg) once daily. Patients with renal impairment : The recommended dose in patients with moderate renal impairment is one Curin tablet every two days. In those with sever renal impairment, the dose interval should be increased to every three days. Patients with end-stage renal disease should not be given Levocetirizine. Side Effects Generally Levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely. Contraindications Curin is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. Use in Pregnancy and Lactation: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the fetus. 112

Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the positive risk to the nursing infant. Pediatric Use Not recommended for use in children less than 6 years of age. Overdosage No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended. Pharmaceuticals Precautions Keep out of reach of children. Keep in a cool dry place. Commercial Pack Curin Tablet : Each box contains 10 blister strips of 10 tablets. Each film coated tablet contains Levocetrizine Dihydrochloride INN 5 mg.

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Decacycline
Capsule

Description Decacycline contains Tetracycline Hydrochloride BP. Tetracycline Hydrochloride is a broad spectrum antibiotic. It is active against a wide range of Gram-positive and Gram-negative bacteria and even some that are resistant to penicillins. It is primarily bacteriostatic in activity. Due to increasing bacterial resistance, Tetracycline use has been decreased. However, it remains the treatment of choice for infections caused by Chlamydia, Rickettsiae, Mycoplasma and Brucella. When penicillin is contraindicated, Tetracycline is an alternative drug in treatment of infections caused by Neisseria gonorrhoeae, Treponema pallidum and Treponema pertenue. Indications Decacycline is indicated in the infections caused by Tetracycline sensitive microorganisms. Respiratory tract infections: Acute and chronic bronchitis, lobar and bronchopneumonia, atypical pneumonia, lung abscess. Gastro-intestinal infections: Amoebic dysentery, bacillary dysentery, enteritis, hepatic infections, cholangitis, and cholecystitis. Genito-urinary infections: Pyelonephritis (acute and chronic), cystitis, urethritis, and epididymitis, non-gonococcal urethritis, gonorrhoea. Soft tissue infections: Mild to moderate acne, typhus fever. Other infections: Trachoma, psittacosis, whooping cough, brucellosis (in combination with other antibacterial drugs), rickettsial fevers, actinomycosis, anthrax, Rocky Mountain spotted fever etc. Dosage and Administration Adults : Usual dose is 250 mg every 6 hours and can be increased in severe infection to 500 mg every 6-8 hours. In case of primary, secondary or 114

latent syphilis : 500 mg every 6 hours for 14-21 days. Non-gonococcal urethritis : 500 mg every 6 hours for 7-14 days. Brucellosis : 500 mg 4 times/day for 3 weeks (accompanied by other antibacterial drugs). Severe acne (long term therapy) : Initially, 1 g/day in divided doses. For maintenance 125-500 mg/day should be given. Children (over 12 years of age) : Daily dose is 10-20 mg/lb (25-50 mg/kg) in 4 equal doses. Contraindication Decacycline is contraindicated in renal impairment, during pregnancy and lactation, children under 12 years of age, systemic lupus erythematosus and hypersensitivity to any other Tetracyclines. Side Effects Gastrointestinal side effects especially nausea, vomiting and diarrhoea are most frequently reported. Glossitis, stomatitis, vaginitis or Staphylococcal enterocolitis may occur. Anaphylaxis may occur on rare occasions. Pharmaceutical Precaution Store in a cool and dry place. Keep out of the reach of children. Use in Pregnancy and Lactation Tetracycline should be avoided in pregnant women, because of the risk of both staining of teeth and effect on bone growth in the foetus. Tetracycline has been found in the breast milk of lactating mothers. There is probably negligible absorption of Tetracycline by breasted infants, because of chelation by the calcium in milk. Commercial Pack Decacycline Capsule : Box containing 10 blister strips of 10 capsule, each capsule contains Tetracycline Hydrochloride BP 250 mg.

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Decomit
Inhaler

Description The active ingredient of Decomit Inhaler (Beclomethasone Dipropionate BP) is a synthetic halogenated corticosteroid with anti-inflammatory activity. Indications Decomit Inhaler (Beclomethasone Dipropionate BP) given by inhalation has a potent anti-inflammatory action within the lungs without the side effects observed when steroids are administered systemically. Decomit inhaler is indicated for the management of patients with bronchial asthma including :

Patients whose asthma is becoming worse and is inadequately controlled by bronchodilator therapy alone Patients whose asthma is not controlled by the combined use of bronchodilator and Sodium Cromoglycate Patients with severe asthma being treated with systemic corticosteroids or synthetic or actual adrenocorticotrophic hormone (ACTH)

Dosage and Administration It may take 1-3 months to achieve maximum therapeutic benefit from any corticosteroid inhalation therapy. Patients should be given a starting dose of inhaled Beclomethasone Dipropionate that is appropriate for the severity of their disease. The dose may then be adjusted until control is achieved or reduced to the minimum effective dose according to individual response. Adults : The usual recommended maintenance dose is 100-250 g given three or four times a day. Alternatively, 200-500 g given twice daily has been effective in some patients. In patients with severe asthma, it is advisable to start with 600 to 1000 g a day and reduce the dose according 116

to the response of the patients. High dose (up to 2000 g daily) may control asthmatics not adequately controlled with more conventional doses. In patients receiving doses of 1500 g or more, adrenal suppression (though may not be clinically significant) may occur which should be balanced against the therapeutic advantages. Children : The usual starting dose is 100 g twice daily. Some patients may require 100 g three to four times daily (or 200 g twice daily). Total dose for children should not exceed 500 g daily. Contraindication Hypersensitivity to Beclomethasone is a contraindication; and special care is necessary in patients with active or quiescent pulmonary tuberculosis. Precautions Patients should be instructed about proper use of the inhalers to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Beclomethasone inhaler has to be used regularly for optimum benefit. Patients should be made aware of the prophylactic nature of therapy with Beclomethasone inhaler and that it should be taken regularly, even when they are asymptomatic. The maximum daily administration of Beclomethasone inhaler should not exceed 1 mg. Significant reduction in plasma cortisone levels has been reported in patients who receive twice this amount. Side Effects Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 g Beclomethasone Dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Some patients may find it helpful to rinse their mouth thoroughly with water after using the inhaler. Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing the Beclomethasone inhaler. In some patients, inhaled Beclomethasone Dipropionate may cause hoarseness or throat irritation. It may be helpful to rinse mouth with water immediately after inhalation. 117

As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. Pharmaceutical Precaution Store below 30 C, keep out of the reach of children. Commercial Pack Decomit 100 Inhaler : Each canister contains 200 metered doses, each containing 100 g of Beclomethasone Dipropionate BP. Decomit 250 Inhaler : Each canister contains 200 metered doses, each containing 250 g of Beclomethasone Dipropionate BP.

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Decomit
Nasal Spray

Description Beclomethasone Dipropionate BP, the active ingredient of Decomit nasal spray, is an anti-inflammatory steroid having the chemical name 9-chloro11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione21dipropionate. Decomit nasal spray is a metered dose manual pump spray unit containing a microcrystalline suspension of Beclomethasone Dipropionate in a mixture of suspending agents. Indications Decomit nasal spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis. Beclomethasone Dipropionate nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Dosage and Administration Decomit nasal spray is for administration by the intranasal route only Adults and children : The recommended dosage is two applications into each nostril twice daily. For some patients, a dosage regimen of a single application into each nostril three or four times daily may be preferred. Total daily administration should not normally exceed eight applications. For full therapeutic benefit, regular usage is essential. The cooperation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum effect may not be obtained within the first few applications. For children under six years, there are insufficient clinical data to recommend its use. Contraindication Decomit nasal spray is contraindicated in patients with a history of hypersensitivity to any of its components.

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Precautions Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Decomit nasal spray. Care must be taken while transferring patients from systemic steroid treatment to Decomit nasal spray if there is any reason to suppose that their adrenal function is impaired. Systemic effects may rarely occur. These include hypothalamic-pituitaryadrenal (HPA) suppression and growth retardation in children. Although Decomit nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy particularly to control eye symptoms. Side Effects As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely. Rare cases of raised intra-ocular pressure or glaucoma in association with intranasal formulations of Beclomethasone Dipropionate have been reported. Pharmaceutical Precaution Decomit nasal spray should be stored at a temperature below 30C. Protect from frost and direct sunlight. Commercial Pack Decomit Nasal Spray : Each bottle contains 200 metered doses, each containing 50 g of Beclomethasone Dipropionate BP.

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Deflux
Tablet/Suspension/Paediatric Drops

Description Deflux (Domperidone) is a dopamine antagonist. As it does not enter the central nervous system, its effect is confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone. Indications Stimulation of gut motility in - Non-ulcer dyspepsia - Oesophageal reflux, reflux oesophagitis and gastritis - Diabetic gastroparesis - Functional dyspepsia - Speeding barium transit in follow through radiological studies
Prevention and symptomatic relief of acute nausea and vomiting from

any cause including cytotoxic therapy, radiotherapy and antiparkinsonism therapy

In the prophylactic treatment of migraine

Dosage and Administration The recommended oral dose for Adults: 10-20 mg every 4-8 hours daily; Children: 0.2-0.4 mg/kg every 4-8 hours daily. Note that Domperidone should be taken 15-30 minutes before meal. For acute vomiting and nausea, maximum period of treatment is 12 weeks. Use in children is restricted to nausea and vomiting following cytotoxic drugs or radiotherapy. Contraindication Deflux is contraindicated to the patients who have hypersensitivity to this drug and in case of neonates. Precautions Deflux should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood brain barrier. 121

Side Effects Domperidone may produce hyperprolactinaemia (1.3% frequency). This may result in galactorrhoea, breast enlargement, soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies. Use in Pregnancy and Lactation The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the foetus. Domperidone may precipitate galactorrhoea and improve post-natal lactation. It is secreted in breast milk but in very small quantities, insufficient to be considered harmful. Drug Interactions Domperidone may reduce the hypoprolactinaemic effect of bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Domperidone on gastrointestinal function. Overdosage There is no reported case of overdosage. Commercial Pack Deflux Tablet : Box containing 10 x 10s blister strips. Each tablet contains Domperidone Maleate BP equivalent to 10 mg Domperidone. Deflux Suspension : Bottle containing 100 ml of suspension. Each 5 ml contains Domperidone BP 5 mg. Deflux Paediatric Drops : Bottle containing 15 ml of drops. Each ml contains Domperidone BP 5 mg.

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Dextromethorphan
Syrup

Description Dextromethorphan Syrup is cherry flavoured liquid, containing in each 5 ml, 10 mg Dextromethorphan Hydrobromide BP. Dextromethorphan (d3-methoxy-N-methylmorphinan) is the d-isomer of the codeine analogue of levorphanol. It is a cough suppressant. Indications As antitussive. Dosage 1-3 teaspoonful 1-4 times daily or as advised by the physician. Warning Not for children use. Contraindication Liver disease. Precautions Should be administered with caution to asthmatic patient. Side Effects Occasionally Dextromethorphan hydrobromide may cause drowsiness, dizziness, excitation, mental confusion and gastrointestinal disturbance. Very high doses may produce respiratory depression. Abuses of Dextromethorphan have been reported in few cases, but there does not appear to be any evidence of dependence of the morphine type. Commercial Pack Dextromethorphan Syrup: 100 ml syrup in glass bottle, each 5 ml contains 10 mg of Dextromethorphan Hydrobromide BP.

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Diactin
Tablet

Description Diactin (Glipizide) is an oral blood glucose lowering drug of the sulfonylurea class which causes hypoglycaemia by stimulating release of insulin from pancreatic cells and by increasing the sensitivity of peripheral tissues to insulin. Indications Diactin (Glipizide) is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin. Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level. During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued. Dosage and Administration Like any other oral hypoglycaemic agent, dosage of Diactin is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet. In general, Diactin should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.

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Initial dose : The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg. Dosage adjustments : Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg. Maintenance : Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long-term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily. In elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions. Patients Receiving Insulin : Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so. Patients receiving other oral hypoglycaemic agents : As with other sulfonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects. Contraindication Diactin is contraindicated in the following conditions :

Patients who are hypersensitive to Glipizide or any component of the product Juvenile onset diabetes Severe or unstable brittle diabetes

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Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease

Precautions Hypoglycaemia : All sulfonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Renal and Hepatic Disease : The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted. Loss of Control on Blood Glucose : When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin. The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug. Side Effects The majority of side effects have been dose-related, transient, and responded to dose reduction or withdrawal of the medication. Hypoglycaemia : See "Precautions" and "Overdosage" section. Gastrointestinal : Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and 126

gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs. Dermatological : Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued. Haematologic : Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulfonylureas. Metabolic : Hepatic porphyria and disulfiram like reactions have been reported with sulfonylurea. Endocrine Reactions : Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas. Miscellaneous : Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy. Warning The administration of oral hypoglycaemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus Insulin. Although the study report was based on use of Tolbutamide only, but from a safety point of view this warning may also be applied for other oral hypoglycaemic agents. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake. Overdosage Overdosage of sulfonylurea including Glipizide can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should be continued until the physician is assured that 127

the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycaemia may recur after apparent clinical recovery. Clearance of Glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of Glipizide, dialysis is unlikely to be of benefit. Drug Interactions The hypoglycaemic action of sulfonylurea may be potentiated by certain drugs including non-steroidal anti-inflammatory agents and other drugs that are highly protein bound e.g. Salicylates, Sulfonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and -adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose. Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide. Use in Pregnancy and Lactation Glipizide was found to be mildly foetotoxic in rat reproductive studies at all dose levels (5-50 mg/kg) like other sulfonylureas. There are no adequate and well controlled studies in pregnant women. Glipizide should

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be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend to use Insulin during pregnancy to maintain blood glucose levels as close to normal as possible. Although it is not known whether Glipizide is excreted in human milk, some sulfonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication. Precautions Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulfonylurea (e.g. Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date. In children safety and effectiveness have not been established. Information for Patients Patients should be informed of the potential risks and advantages of Glipizide and of alternative modes of therapy. They should also be informed about the importance of adhering to dietary instructions, of a regular exercise programme, and of regular testing of urine and/or blood glucose. The risks of hypoglycaemia, its symptoms and treatment, and conditions those predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained. Pharmaceutical Precaution Store below 25 C. Commercial Pack Diactin Tablet : Box containing 10 aluminium strips of 10 tablets. Each tablet contains Glipizide BP 5 mg.

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Diaglit
Tablet

Description Diaglit (Pioglitazone) is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Pioglitazone decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin-dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferatoractivated receptor gamma (PPAR-). Indications Diaglit is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Diaglit is indicated for monotherapy and also indicated for use in combination with sulfonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control. Dosage and Administration Diaglit can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Diaglit monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered. Maximum recommended daily dose of Diaglit should not exceed 45 mg since doses higher than 45 mg have not been studied in placebocontrolled clinical studies. Besides, no placebo-controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy. Side Effects The overall incidence and types of adverse events reported in placebo controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg, 130

15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%). Precautions Pioglitazone exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type-1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly. Use in Pregnancy and Lactation There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women. Contraindication Diaglit is contraindicated in patients with known hypersensitivity to any of its components. Drug Interactions Administration of thiazolidinediones with an oral contraceptive containing ethinyl estradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception. Overdosage In the event of overdosage, appropriate supportive treatment should be initiated according to patients clinical signs and symptoms. Pharmaceutical Precaution Store at 25o C. Keep in a cool and dry place, away from direct sunlight. Keep out of the reach of children.

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Commercial Pack Diaglit 15 Tablet : Box containing 30 tablets in 3 x 10s blister strips, each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg. Diaglit 30 Tablet : Box containing 30 tablets in 3 x 10s blister strips, each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 30 mg.

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Diapro
Tablet

Description Diapro (Gliclazide) is a second generation sulfonylurea that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the influx of calcium ions into pancreatic cells and as a result increases Insulin secretion. Moreover, in vivo studies have demonstrated changes in thrombin-induced platelet aggregation in NIDDM patients treated with gliclazide. Indications Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed. Dosage and Administration Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily. Adverse Reactions Potentially life-threatening effects- All hypoglycaemic agents have the potential to cause severe hypoglycaemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than Glyburide to cause hypoglycaemia. Hypoglycaemia may be favoured by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency. Severe or irreversible adverse effects- Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycaemia (overdose effect), gastrointestinal disturbances and dermatological reactions. Symptomatic adverse effects- Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash,

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pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon. High Risk Group Neonates- The drug is not used in neonates. Nursing mothers- The drug should not be used by lactating mothers. Children- Gliclazide is contraindicated in children. Pregnant women- Gliclazide, as other sulfonylurea, is contraindicated for use in pregnant women. No teratogenic changes have been found in animals or human, but diabetes can be controlled more effectively in pregnancy by Insulin than by oral hypoglycaemic agents. Elderly- All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycaemia. Concurrent disease- Definite hepatic disease should contraindicate the use of Gliclazide, since it is almost completely metabolized in the liver. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when serum creatinine starts to rise. Drug Interactions Potentially hazardous interactions- These may be divided into those which will tend to increase the hypoglycaemic effect and those tending to oppose it. In the first category come drugs which displace the sulfonylurea from protein binding, such as Aspirin, non-steroidal antiinflammatory drugs, Phenylbutazone, Clofibrate, Sulfonamides and Coumarin anticoagulants; or which inhibit, hepatic microsomal enzymes, for example Cimetidine, sulfonamides, imidazole antifungal agents and the Monoamine Oxidase Inhibitors (MAOI), which may increase the hypoglycaemic effect of Gliclazide. Any effects, which result from protein-binding displacement, are transient, lasting from 12-24 h. Regular concomitant doses of these agents together with a constant dose of Gliclazide would not cause problems. The hypoglycaemic action of sulfonylureas may be opposed by the induction of hepatic enzymes, which metabolize the drug causing lower plasma concentrations and less hypoglycaemic effect. Common inducers include Rifampicin, barbiturates, Phenytoin and alcohol, or by drugs that 134

inhibit the release or action of Insulin, e.g. thiazide diuretics, dizoxide, glucocorticoids, oestrogens or sympathomimetic drugs. Early symptoms of hypoglycaemia such as tremor, sweating and tachycardia may be masked by -adrenoreceptor blocking drugs, such as Propranolol allowing severe hypoglycaemic episodes without preceding warning symptoms. If -adrenoreceptor blocking drugs are required the more selective types, such as Metoprolol or Atenolol, are preferred in the diabetic patient. Pharmaceutical Precaution Store below 250 C. Commercial Pack Diapro Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Gliclazide BP 80 mg.

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Diaryl
Tablet

Description Diaryl (Glimepiride) tablets are an oral blood-glucose-lowering drug of the sulfonylurea class. Chemically, glimepiride is identified as 1-[[p-[2-(3ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]3-(trans-4-methylcyclohexyl) urea. Pharmacology The primary mechanism of action of Glimepiride is lowering of blood glucose by stimulating the release of insulin from functioning pancreatic cells. In addition, extra-pancreatic effects may also play vital role in the activity of Glimepiride. Administration of Diaryl can lead to increase sensitivity of peripheral tissues to insulin. After oral administration. Glimepiride is completely (100%) absorbed from gastrointestinal tract. When Glimepiride is given with meals, the mean T max is slightly increased (12%) and the mean Cmax and AUC are slightly decreased. Glimepiride is completely metabolized by oxidative biotransformation after oral dose. When 14 C-Glimepride is given orally, approximately 60% of the total radioactivity is recovered in the urine in 7 days and 80-90% of the metabolites are recovered in the urine. Indications Non-insulin dependent (type-III) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction. Diaryl is also indicated for use in combination with Insulin to lower blood glucose in patients whose hyperglycaemia can not be controlled by diet and exercise or in conjunction with an oral hypoglycaemic agent. Dosage and Administration In principle, the dosage of Diaryl is governed by the desired blood sugar level. The dosage of Diaryl must be the lowest which is sufficient to achieve the desired metabolic control.

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The initial and the maintenance doses are set based on the results of regular checking of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy. Initial dose and dose titration : Usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks and carried out stepwise at follows: 1 mg-2 mg-3 mg-4 mg-6 mg. Dose range in patients with well controlled diabetes: Usual dose range in patients with well controlled diabetes is 1 to 4 mg daily. Distribution of doses : Timing and distribution of doses are decided by the physician, in consideration of the patient's current life style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or - if none is taken - immediately before the first main meals. It is very important not to skip meals after taking the drug. Secondary dosage adjustment : As the control of diabetes improves, sensitivity to insulin increases; therefore, Diaryl requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life style changes, or other factors arise which cause an increased susceptibility to hypo- or hyperglycaemia. Changeover from other oral antidiabetics to Diaryl : There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from the maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration.

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Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia. Administration : Diaryl tablet must be swallowed without chewing and with sufficient amount of liquid (approximately glass). Contraindication Glimepiride is not suitable for the treatment of insulin dependent (typeI) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride must not be used in patients hypersensitive to Glimepiride or other sulphonylureas. Precautions In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycaemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g. sugar sweetened fruit juice or sugar sweetened tea). Side Effects Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure. Drug Interactions Potentiation of the blood-sugar-lowering effect may occur with Insulin and other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolic steroids and male sex hormones, Chloramphenicol, coumarin derivatives, Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid, Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone, quinolones, salicylates, Sulfonamides, tetracyclines, blockers. Weakening of the blood-sugar-lowering effect may occur with Acetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics, Epinephrine and other sympathomimetic agents, laxative, oestrogens and progestogens, phenothiazines, Phenytoin, Rifampicin, and thyroid hormones. 138

H 2 -receptor antagonists, Clonidine and Reserpine may lead to either potentiation or weakening of the blood-sugar-lowering effect. Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Glimepiride unpredictably. Use in Pregnancy and Lactation Glimepiride must not be taken during pregnancy; a changeover to Insulin is necessary. Patients planning a pregnancy must inform their physician, and should changeover to Insulin. Ingestion of Glimepiride with breast milk may harm the child. Therefore, Glimepiride must not be taken by lactating women. Either a changeover or a complete discontinuation of breast-feeding is necessary. Commercial Pack Diaryl 1 Tablet : Each box contains 3 x 10s tablets in blister strips. Each tablet contains Glimepiride INN 1 mg. Diaryl 2 Tablet : Each box contains 3 x 10s tablets in blister strips. Each tablet contains Glimepiride INN 2 mg. Diaryl 1 Tablet : Each tablet contains Glimepiride INN 1 mg. Diaryl 2: Each tablet contains Glimepiride INN 2 mg

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Diavix
Tablet

Description Diavix Tablets are combination tablets containing Lamivudine INN 150 mg and Zidovudine USP 300 mg. Indications Diavix is indicated for the treatment of HIV infection. Dosage and Administration The recommended oral dose of Diavix for adults and adolescents (at least 12 years of age) is one tablet (containing 150 mg of Lamivudine and 300 mg of Zidovudine) twice daily. Dose Adjustment : As it is a fixed-dose combination, Diavix should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance <50 ml/min), those with low body weight (<50 kg or 110 lb), or those experiencing dose-limiting adverse events. Diavix is not recommended for patients with impaired hepatic function, as Diavix is a fixed-dose combination that cannot be adjusted for this patient population. Contraindication Diavix Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product. General : Reduction of doses of Lamivudine is recommended for patients with low body weight (less than 50 kg or 110 lb); therefore, patients with low body weight should not receive Diavix. Warning and Precautions Zidovudine, one of the two active ingredients in Diavix, has been associated with haematologic toxicity including neutropenia and severe 140

anaemia, particularly in patients with advanced HIV disease. Prolonged use of Zidovudine has been associated with symptomatic myopathy. Post-treatment Exacerbations of Hepatitis : In clinical trials in non-HIVinfected patients treated with Lamivudine for chronic hepatitis B, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of Lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of hepatitis B viral DNA (HBV DNA). Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from post-marketing experience after changes from Lamivudine-containing HIV treatment regimens to nonLamivudine-containing regimens in patients infected with both HIV and HBV. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. There is insufficient evidence to determine whether re-initiation of Lamivudine alters the course of post-treatment exacerbations of hepatitis. Ordinarily, Diavix should not be administered concomitantly with either Lamivudine or Zidovudine. Bone Marrow Suppression : Diavix should be used with caution in bone marrow compromised patients evidenced by granulocyte count <1,000 cells/mm 3 or haemoglobin <9.5 g/dl. Frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with Diavix. For HIV-infected individuals and patients with asymptomatic or early HIV disease, periodic blood counts are recommended. Lactic Acidosis/Severe Hepatomegaly with Steatosis : Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including Zidovudine and Lamivudine. A majority of these cases have been in women. Caution should be exercised when administering Diavix to any patient, and particularly to those with known risk factors for liver disease. Treatment with Diavix should be suspended in any patient who

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develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity. Patients with HIV and Hepatitis B Virus Co-infection : Safety and efficacy of Lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. In non-HIV-infected patients treated with Lamivudine for chronic hepatitis B, emergence of Lamivudine-resistant HBV has been detected and has been associated with diminished treatment response. Emergence of hepatitis B virus variants associated with resistance to Lamivudine has also been reported in HIV-infected patients who have received Lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. Post-treatment exacerbations of hepatitis have also been reported. Side Effects General : Headache, malaise, fatigue, fever or chills, weakness. Gastrointestinal : Nausea and vomiting, diarrhoea, anorexia and/or decreased appetite, abdominal pain or cramps, dyspepsia. Nervous system : Neuropathy, insomnia and other sleep disorders, dizziness, depressive disorders. Respiratory : Nasal signs and symptoms, cough. Skin : Skin rashes. Musculoskeletal : Musculoskeletal pain, myalgia, arthralgia. The following events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to Lamivudine and/or Zidovudine or a combination of these factors. Cardiovascular : Cardiomyopathy, vasculitis. Endocrine and Metabolic : Gynaecomastia, hyperglycaemia. Gastrointestinal : Oral mucosal pigmentation, stomatitis. Haemic and Lymphatic : Aplastic anaemia, anaemia, lymphadenopathy, pure red cell aplasia, spleenomegaly. Hepatic and Pancreatic : Lactic acidosis and hepatic steatosis, steatosis, pancreatitis, post-treatment exacerbation of hepatitis B infection. Hypersensitivity : Sensitisation reactions (including anaphylaxis), urticaria. Musculoskeletal : Muscle weakness, elevation of creatinephosphokinase (CPK), rhabdomyolysis. Nervous system : Paraesthesia, peripheral neuropathy, seizures. Respiratory system : Abnormal breath sounds/wheezing. Skin : Alopecia, erythema multiforme, StevensJohnson syndrome.

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Overdose There is no experience of overdosage with Lamivudine and Zidovudine combination. However, there are limited data available on the consequences of ingestion of acute overdoses of Lamivudine and Zidovudine in humans. No fatalities occurred, and all patients recovered. No special signs or symptoms have been identified following such overdosage. If overdosage occurs the patients should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Since Lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied. Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of Zidovudine, but enhance the elimination of the glucuronide metabolite. Pharmaceutical Precaution Store in a cool dry place. Protect from light. Keep out of reach of children. Commercial Pack Diavix Tablets : Each tablet contains Lamivudine INN 150 mg and Zidovudine USP 300 mg. Each box contains 1 x 10s tablets in blister strip.

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Dilapress
Tablet

Description Dilapress (Carvedilol) is a cardiovascular drug which mainly acts as neurohormonal antagonist consisting of non-selective -blockade, 1blockade and antioxidant properties. Indications Dilapress is indicated for the treatment of essential hypertension. It can be used alone or in combination with other antihypertensive agents, especially thiazide type of diuretics. Dilapress is also indicated for the treatment of mild to moderate heart failure, to reduce the progression of disease, to reduce mortality and cardiovascular hospitalization. Dilapress may be used in patients unable to tolerate an ACE inhibitor. Dilapress may be used in patients who are not receiving digitalis, hydralazine or nitrate therapy. Dosage and Administration In essential hypertension initially 12.5 mg once daily for 2 days is recommended. Thereafter the recommended dose is 25 mg once daily. If necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients the initial dose of 12.5 mg daily may provide satisfactory control. In heart failure, initially 3.125 mg twice daily may be given for 2 weeks, dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body weight and 50 mg twice daily in patients over 85 kg.

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In angina pectoris the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dose is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses. Contraindication Dilapress must not be used in patients with New York Heart Association (NYHA) class IV decompensated heart failure requiring intravenous inotropic support, Asthma, Chronic obstructive pulmonary disease (COPD) with a bronchospastic component, 2nd or 3rd degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia. Therapy is not to be initiated in severe heart failure. Side Effects Dizziness, headache, fatigue, gastrointestinal disturbances, postural hypotension, peripheral oedema, bradycardia, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms. Rarely angina, AV block, exacerbation of intermittent claudication or Raynauds phenomenon, allergic skin reactions, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leucopenia are also reported. Precautions Take precaution in hepatic impairment, and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating. Use in Pregnancy and Lactation Carvedilol should not be used during pregnancy as no studies have been performed in this group. Carvedilol and its metabolites are excreted in breast milk. Therefore, breastfeeding is not recommended during administration of Carvedilol. Drug Interactions As with other anti-hypertensive, there is a potential for pronounced hypotension during general anaesthesia. 145

As with other agents with -blocking activity, Carvedilol may potentiate the effect of other concomitant administered drugs that are antihypertensive in action or have hypotension as part of their adverse effect profile. As with other drugs with -blocking activity, caution should be exercised when administered Class I anti-arrhythmic drugs or calcium antagonists such as Verapamil. These drugs should be administered intravenously. Plasma Digoxin levels may be increased in patients to whom Carvedilol and Digoxin are co-administered. Increased monitoring of Digoxin levels is recommended when initiating, adjusting or discontinuing Carvedilol. Care should be required in those receiving inducers of mixed function oxidase e.g. Rifampicin, as serum levels of Carvedilol may be reduced. Pharmaceutical Precaution Store at temperature between 150 C to 300 C. Commercial Pack Dilapress 6.25 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Carvedilol BP 6.25 mg. Dilapress 12.5 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Carvedilol BP 12.5 mg. Dilapress 25 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Carvedilol BP 25 mg.

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Ecotrim
Cream

Description Ecotrim cream is a soft white cream containing 1% Econazole Nitrate BP and 0.1% Triamcinolone Acetonide BP. Indications Econazole Nitrate is a broad spectrum antifungal agent. It is effective against various dermatophytes, yeasts and moulds. Moreover, it has activity against Gram-positive bacteria. Triamcinolone Acetonide is a potent corticosteroid with anti-inflammatory, antipruritic and antiallergic activity. The more important indications of Ecotrim are dermatomycosis caused by dermatophytol yeast and fungus with clear inflammatory and allergic symptoms such as various eczematous mycosis, diaper dermatitis, eczema marginatum, intertrigo, folliculitis, tricophytica and sycosis barbae. Ecotrim is also indicated for the treatment of mycosis present in various folds of the body. Dosage and Application The cream should be applied by gently rubbing into the skin with the finger once or twice daily for 14 days or as directed by a registered physician. Contraindication Like all preparations containing corticosteroids, Ecotrim cream should not be used on tubercular skin infections or in viral diseases (e.g. herpes, vaccinia, and varicella). Use in Pregnancy The use of corticosteroids during pregnancy has not been established. Topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

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Precautions Long term continuous steroid therapy should be avoided since adrenal suppression can occur, particularly when infants or children are treated or when occlusive dressings are applied. Discontinuation of the medication is advised if hypersensitivity occurs. Side Effects Ecotrim cream is well tolerated, even to sensitive skin. Burning sensation, pruritis and redness of skin have rarely been reported. Additional Information The infected area should be kept clean and dry during treatment Keep the medication out of reach of children To be dispensed only upon the prescription of a registered physician Commercial Pack Ecotrim Cream : Tube containing 10 g cream, each gram contains Econazole Nitrate BP 10 mg and Triamcinolone Acetonide BP 1 mg.

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EfolER
Capsule

Description Each Efol extended release capsule contains 150 mg of Dried Ferrous Sulphate BP equivalent to 47 mg Iron, 500 g Folic Acid USP and 61.8 mg of Zinc Sulphate Monohydrate USP equivalent to 22.5 mg Zinc. It is a clear, transparent capsule filled with a mixture of red, pale yellow, pink and white pellets. This capsule is especially formulated for extended release of iron over a period of several hours and that of zinc over one to two hours. Indications Efol ER is indicated for the treatment of iron, folic acid and zinc deficiency. Efol ER is also indicated on prophylaxis of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy. Dosage and Administration Prophylaxis Adult One capsule a day. In more severe cases, two capsules a day may be required as prescribed by the physician.
Elderly

Dosage as above.
Children aged over 1 year

One capsule a day, the capsule may be opened and the pellets can be mixed with soft cool food but they must not be chewed. Treatment Recommended dose is 2 to 4 capsules a day or as prescribed by the physician. Contraindication It is contraindicated in patients with haemolytic anaemia and in conditions 149

with increased hypersensitivity to any of its components and increased body iron content. Use in Pregnancy Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required. Side Effects Side effects of iron, folic acid and zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea etc. The blended Efol ER capsule is especially designed to reduce the possibility of gastrointestinal irritation. Drug Interactions Iron chelates with Tetracycline. Since oral iron products interfere with absorption of oral Tetracycline, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. In patients with renal failure, a risk of zinc accumulation may exist. Overdosage Overdosage of iron is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, vomiting may also be induced. Zinc Sulphate in gross overdosage is corrosive. Symptoms are those of gastrointestinal irritation, leading in severe cases to haemorrhagic corrosion of the mucosa and possible later stricture formation. Demulcent such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic acid have been recommended. The extended release capsule presentation may delay excessive absorption of iron and zinc and allow more time for initiation of appropriate counter measures. Precautions Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia.

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Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Pharmaceutical Precaution Store in a dry place below 25C and protect from sunlight. Keep out of the reach of children. Commercial Pack Efol ER Capsule : Box containing 50 capsules in 5 x 10's blister strips. Each capsule contains Dried Ferrous Sulphate BP 150 mg equivalent to Iron 47 mg, Folic Acid USP 500 g and Zinc Sulphate Monohydrate USP 61.8 mg equivalent to Zinc 22.5 mg.

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Enaril
Tablet Description Enaril (Enalapril Maleate) is the maleate salt of Enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme (ACE) inhibitor, enalaprilat. It is highly effective in the management of hypertension and heart failure. Indications Enaril is indicated for the treatment of all grades of essential hypertension, renovascular hypertension and heart failure. Dosage and administration Essential and Renovascular Hypertension : Treatment should be initiated with 5 mg once a day. Where concomitant therapy is a diuretic, the recommended initial dose of Enaril is 2.5 mg. The dose should be titrated to give optimum control of blood pressure. The usual maintenance dose is 10-20 mg given once daily. In severe hypertension, the dosage may be increased incrementally to a maximum of 40 mg once daily. Heart Failure : Enaril can be used as an adjunctive therapy with nonpotassium-sparing diuretics and/or digitalis. The recommended starting dose of Enaril is 2.5 mg once daily. The dose of Enaril should be gradually increased depending upon tolerability to the recommended maintenance dose (10-20 mg) given as a single or twice daily dose. The absorption of Enaril is not affected by food. The maximum daily dose is 40 mg. Use in the elderly (over 65 years) : The starting dose should be 2.5 mg. Enaril is effective in the treatment of hypertension in the elderly. The dose should be titrated according to need for the control of blood pressure. Contraindication Pregnancy : Enalapril is contraindicated in pregnancy and treatment should be stopped if pregnancy is suspected, because it has been found to be foetotoxic in rabbits. Hypersensitivity : Enaril is also contraindicated in patients who are 152

hypersensitive to any component of this product and in patients with a history of angioneurotic oedema relating to previous treatment with an ACE inhibitor. Precautions Hypotension : Symptomatic hypotension has been reported mainly in patients with severe heart failure. In these patients, by discontinuing diuretic therapy or significantly reducing the diuretic dose for two to three days prior to initiating Enalapril, the possibility of this occurrence is reduced. By initiating therapy with a small dose (2.5 mg), the duration of any hypotensive effect may be lessened. If hypotension develops, the patient should be placed in a supine position. Volume repletion with oral fluids or intravenous normal saline may be required. Impaired renal function : Enalapril should be used with caution in patients with renal insufficiency as they may require reduced or less frequent doses. Renal failure has been reported in association with Enalapril and has been mainly in patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis. If recognized promptly and treated appropriately, renal failure is usually reversible. Angioneurotic oedema : Angioneurotic oedema has been reported with ACE inhibitors including Enalapril. In such cases, Enaril should be discontinued immediately and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. Where swelling is confined to the face, lips and mouth, the condition will usually resolve without further treatment, although antihistamines may be useful in relieving symptoms. However, where there is involvement of the tongue, glottis or larynx, likely to cause airways obstruction, appropriate therapy such as subcutaneous adrenaline 1:1000 (0.5 ml) should be administered promptly. Cough : Cough has been reported with the use of ACE inhibitors. Surgery/Anaesthesia : In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, Enalapril blocks 153

angiotensin II formation secondary to compensatory renin release. This may lead to hypotension which can be corrected by volume expansion. Lactating mothers : Enalapril and Enalaprilat are excreted in breast milk; caution should be exercised if Enaril is given to lactating mothers. Drug Interactions Combination with other antihypertensive agents such as -blockers, Methyldopa, calcium antagonists and diuretics may increase the antihypertensive efficacy. Adrenergic-blocking drugs should only be combined with Enalapril under careful supervision. Concomitant Propranolol may reduce the bioavailability of Enalapril, but this does not appear to be of any clinical significance. Concomitant therapy with Lithium may increase the serum Lithium concentration. Side Effects The commonly reported side effects are dizziness and headache. Other side effects occurring less frequently include orthostatic hypotension, nausea, rash, cough etc. Cardiovascular : Myocardial infarction or cerebrovascular accident, possibly secondary to severe hypotension in high-risk patients. Palpitation, rhythm disturbances. Gastrointestinal : Abdominal pain, dyspepsia, hepatitis, jaundice. Nervous system : Confusion, nervousness, insomnia, somnolence. Respiratory : Sore throat, hoarseness of voice. Skin : Urticaria, pruritus. Special senses : Blurred vision. Renal : Oliguria, renal dysfunction, renal failure are reported in rare cases. Overdosage Limited data are available for overdosage in humans. The most prominent feature of overdosage is hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Enaril can be removed from general circulation by haemodialysis. Pharmaceutical Precaution Store in a dry place below 25 C, protected from light. Commercial Pack Enaril Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains 5 mg of Enalapril Maleate USP. 154

Epilep
Tablet

Description Carbamazepine is an iminodibenzyl derivative with anticonvulsant properties and its structure is related to the tricyclic antidepressants. It is a white or yellowish-white, crystalline, almost odourless powder which is tasteless or with a slightly bitter taste. Indications Carbamazepine is indicated in all forms of epilepsy except myoclonic and absence seizures, trigeminal neuralgia, mood disorder, aggression and diabetes insipidus. Dosage and Administration Epilepsy : Dosage in adults : 100-200 mg once or twice daily and this is then gradually increased by 200 mg daily every week. The best response is often obtained with doses of 800-1200 mg daily. In some instances 1600 mg or even 2000 mg daily may be necessary. Dosage in children : The dose in children is determined on the basis of body weight (10-20 mg/kg) and age. Children up to 1 year of age : 100300 mg daily in two to four divided doses. Children between 1 to 5 years of age: 200-400 mg daily in two to four divided doses. Children between 6 to 10 years of age : 400-600 mg daily in two to four divided doses. Children between 11 to 15 years of age : 600-1000 mg daily in two to four divided doses. Trigeminal neuralgia : The initial dose is usually 200 mg daily. In some instances a dose of 1600 mg daily is necessary. Mood disorder : In patients unresponsive to Lithium therapy, a starting dose of 400-600 mg daily is used. Diabetes insipidus : 200 mg two to three times daily. In children the dose should be determined according to body weight (10-20 mg/kg).

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Side Effects
Potentially life-threatening Aplastic anaemia, Agranulocytosis, Fatal hepatitis, Severe exfoliative dermatitis, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Lupus erythematosus Severe or irreversible Generalized erythematous skin rashes, Transient leucopenia, Thrombocytopenia, Oliguria, Haematuria, Proteinuria, Renal failure, Bradycardia, Heart failure Symptomatic Dizziness, Ataxia, Headache, Diplopia, Drowsiness, Nausea, Vomiting, Asthenia

Precautions Carbamazepine should be used with caution in cardiovascular disease, hepatic or renal disorders, changing treatment from Carbamazepine to another antiepileptic drug, haematological disorder, glaucoma etc. Drug Interactions
Drugs Anticoagulants Oral contraceptive Propoxyphene Fluvoamine MAO Inhibitors Anticonvulsants Alcohol Doxycycline Salicylic Acid Vitamin D Lithium Effects Reduced anticoagulant effect Increased contraceptive effect Interference with the metabolism and clearance of Carbamazepine Provoked symptomatic Carbamazepine toxicity Increased incidence of cardiac arrhythmias Induction of hepatic microsomal enzyme CNS side effects of Carbamazepine possibly increased Shorter half-life of Doxycycline Increased free Carbamazepine concentration in plasma Interference with the metabolism of Vitamin D Neurotoxic reactions have been occurred.

Contraindication Previous sensitivity to Carbamazepine or structurally related drugs, atrioventricular conduction abnormalities, history of previous bone marrow depression or of intermittent porphyria.

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Use in Pregnancy and Lactation There is definite evidence of risk to the human foetus, but this may be overweighed by the therapeutic benefit for the mother. Pregnant women with epilepsy should be kept under close surveillance. Pregnancy decreased the plasma concentration of Carbamazepine. This is largely the result of an increase in the rate of metabolism. It may therefore be necessary to increase the dose of Carbamazepine during pregnancy in order to maintain a satisfactory clinical response. Carbamazepine and its main metabolite, Carbamazepine-10, 11-epoxide, are both present in breast milk of nursing mothers in concentrations of between 30-60% of those in plasma. Breast-feeding is not contraindicated, however, because the amount of drug ingested by the breasted infant is too small to cause any adverse pharmacological effects. Acute Overdosage Doses of up to 20 g are known to have been taken but no deaths have been reported. The symptoms of overdosage include erythema of the face, tremor, ataxia, psychomotor restlessness, changes in blood pressure, muscle hypotonia, and dilatation of the pupils, unconsciousness and convulsions. Pharmaceutical Precaution Store at 25 oC. Keep in a cool and dry place, away from direct sunlight. Commercial Pack Epilep Tablet : Each box contains 5 x 10s tablets in blister strips. Each tablet contains Carbamazepine BP 200 mg. Epilep CR Tablet : Each box contains 5 x 10s tablets in blister strips. Each CR tablet contains Carbamazepine BP 200 mg.

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Eplon
Capsule

Description Eplon (Zaleplon) is a newer non-benzodiazepine hypnotic from the pyrazolopyrimidine class. So, its chemical structure is unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with the gamma aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex. Indication Eplon is indicated for the short-term treatment of insomnia. Eplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical trials. Dosage and administration The dose of Eplon should be individualized. The recommended dose of Eplon for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Eplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for occasional patient who does not benefit from a trial of lower dose. Dosage above 20 mg has not been adequately evaluated and is not recommended. Eplon should be taken immediately before bedtime. Taking Eplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Eplon on sleep latency. Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotic, and respond to 5 mg of Eplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended. For patients with mild to moderate renal impairment no dose adjustment is necessary. An initial dose of 5 mg should be given to patients concomitantly taking Cimetidine because Zaleplon clearance is reduced in this population.

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Contraindication None known. Side Effects Side effects of Eplon appear to be dose related. So, it is important to use the lowest possible effective dose, specially in the elderly. The side effects are usually mild and transient, the most common are diarrhoea, nausea, vomiting, vertigo, headache, asthenia, nightmare etc. Precautions Timing of drug administration : Eplon should be taken immediately before bedtime or after the patient has gone to bed. Use in the elderly and/or debilitated patients : Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. A dose of 5 mg is recommended for elderly patients to decrease the possibility of side effects. Elderly and/or debilitated patients should be monitored closely. Use in patients with concomitant illness : Eplon should be used with caution in patients with diseases or conditions that could affect metabolism or haemodynamic responses. Although preliminary studies did not reveal respiratory depressant effects at hypnotic doses of Zaleplon in normal subjects, caution should be observed if Zaleplon is prescribed to patients with compromised respiratory function, because sedative/hypnotic have the capacity to depress respiratory drive. However, patients with compromised respiration due to preexisting illness should be monitored carefully. The dose of Eplon should be reduced to 5 mg in patients with mild to moderate hepatic impairment. It is not recommended for use in patients with severe hepatic impairment. No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.

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Use in patients with depression : As with other sedative/hypnotic drugs, Eplon should be administered with caution to patients exhibiting signs or symptoms of depression. Use in Pregnancy and Lactation There are no studies of Zaleplon in pregnant women; therefore, it is not recommended for use in women during pregnancy. Eplon has no established use in labour and delivery. A study in lactating mothers indicated that the clearance and half-life of Zaleplon is similar to that in young normal subjects. A small amount of Zaleplon is excreted in breast milk, with the highest excreted amount occurring during a feeding at approximately 1 hour after Zaleplon administration. Since the small amount of the drug from breast milk may result in potentially important concentrations in infants, and because the effects of Zaleplon on a nursing infant are not known, it is not recommended in nursing mothers. Paediatric Use The safety and effectiveness of Zaleplon in paediatric patients have not been established. Overdosage It is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death. Drug Interactions Zaleplon has been shown to have minimal effects on the kinetic of Warfarin, Imipramine, Ethanol, Ibuprofen, Diphenhydramine, Thioridazine, and Digoxin. Pharmaceutical Precaution Store at controlled room temperature, 20 C-25C.

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Commercial Pack Eplon 5 Capsule : Box containing 3 x 10s capsule in blister strips. Each capsule contains 5 mg Zaleplon INN. Eplon 10 Capsule : Box containing 3 x 10s capsule in blister strips. Each capsule contains 10 mg Zaleplon INN.

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Etrocin
Tablet/Suspension

Description Etrocin suspension is a preparation of Erythromycin Ethylsuccinate. After reconstitution each 5 ml contains Erythromycin Ethylsuccinate USP equivalent to 125 mg Erythromycin. Enteric-coated Etrocin tablet is a preparation of Erythromycin USP and is available in potencies of 250 and 500 mg. Antimicrobial Actions Its range of antimicrobial action is similar to that of penicillin. It is active against most Gram-positive and some Gram-negative bacteria including Neisseria species, Haemophilus influenzae and Bordetella pertussis, against spirochete and some rickettsiae and chlamydia. Micoplasma pneumoniae is very sensitive to Erythromycin, Streptococcus pneumoniae and haemolytic streptococci are highly sensitive but streptococci (including those resistant to penicillin) are rather less sensitive. Although the Enterobacteriaceae are generally resistant to Erythromycin, some strains of Escherichia coli and Klebsiella species have been reported to be sensitive at an alkaline pH. The Gram-negative bacterium responsible for legionnaires disease known as Legionella pneumophila is reported to be sensitive to Erythromycin. Indications Etrocin is highly effective in the treatment of a great variety of clinical infections caused by Erythromycin sensitive organisms. Upper Respiratory Tract infections : Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in cold and influenza. Lower Respiratory Tract infections : Tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, broncho-pneumonia, primary atypical pneumonia), bronchiectasis, legionnaires disease. Ear infection : Otitis media and otitis externa, mastoiditis. Oral infection : Gingivitis, Vincents angina. Eye infection: Blepharitis. Skin and Soft Tissue infections : Boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas. Gastrointestinal infections : Cholecystitis, staphylococcal enterocolitis. Prophylactic use : Pre- and post-operative trauma, burns, rheumatic fever. Other 162

infections: Osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever. Dosage and Administration In case of suspension, optimum blood levels are obtained, when doses are given on an empty stomach. Etrocin tablet can be given before, during or after meal. Adults and children over 8 years : 250-500 mg every 6 hours or 0.5 -1 g every 12 hours. This may be increased up to 4 g per day according to the severity of infection. Elderly : Same as for adults. Children : Age, weight and severity of infection are important factors in determining the correct dosage. The usual regimen is 30-50 mg/kg/day in divided doses or as directed by the physician. For more severe infections this dosage may be doubled. If administration on a twice daily schedule is desirable, one half of the total daily dose may be given every 12 hours, one hour before meal. Amoebic dysentery : Adult- 250-500 mg four times daily for 10 to 14 days. Children- 30-50 mg/kg/day in divided doses for 10-14 days. Pertussis : Although optimum dosage and duration of treatment have not been established, doses of Erythromycin utilized in reported clinical studies were 40-50 mg/kg/day given in divided doses for 5-14 days. Streptococcal infections : In the treatment of group A beta haemolytic streptococcal infections, therapeutic dosage of Erythromycin should be administered for at least 10 days. Prophylaxis : In continuous prophylaxis of streptococcal infections in persons with a history of rheumatic heart disease, the dosage is 250 mg twice daily. When Etrocin is used prior to surgery to prevent endocarditis caused by -haemolytic streptococci, a recommended schedule for children- 20 163

mg/kg 1.5-2 hours pre-operatively and 10 mg/kg every six hours for eight doses post-operatively. For adults the dose is 1 g, 1.5-2 hours preoperatively and 500 mg every six hours for eight doses post-operatively. Contraindication It is contraindicated in patients hypersensitive to Erythromycin. Warning Since Erythromycin is metabolized principally by the liver, caution should be exercised in administering the antibiotic to patient with impaired hepatic function. There have been reports of hepatic dysfunction with or without jaundice occurring in patients taking oral Erythromycin. Use in Pregnancy and Lactation Clinical and laboratory studies have no evidence of teratogenecity or toxicity. However, caution should be exercised when prescribing for the pregnant women. Erythromycin is readily excreted in breast milk. Precautions The use of Erythromycin in patients who are receiving concomitant high doses of Theophylline may be associated with Theophylline toxicity due to increase level of Theophylline in the serum. If symptoms of toxicity develop, the dose of Theophylline should be reduced. Side Effects Serious side effects are rare. The most frequent side effects of Erythromycin preparation are gastrointestinal (e.g. abdominal cramping and discomfort) and these are dose related. Nausea, vomiting and diarrhoea occur infrequently with usual oral doses. Mild allergic reactions such as urticaria and other skin rashes, have occurred. Serious allergic reactions, including anaphylaxis have been reported. Overdosage Symptoms are mainly confined to nausea, vomiting and diarrhoea. General management may consist of supportive therapy.

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Pharmaceutical Precaution Keep the container tightly closed and protected from light. Store in a cool and dry place. Suspension should be shaken well before use. Commercial Pack Etrocin Tablet : Box containing 100 enteric-coated tablets in 10 x 10s blister strips, each tablet contains 250 mg Erythromycin USP. Etrocin-500 Tablet : Box containing 50 enteric-coated tablets in 5 x 10s blister strips, each tablet contains 500 mg Erythromycin USP. Etrocin Suspension : Bottle containing dry powder for 100 ml suspension. After reconstitution each 5 ml contains Erythromycin Ethylsuccinate USP equivalent to 125 mg Erythromycin.

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Evo
Tablet Description Evo (Levofloxacin) is a synthetic, broad-spectrum antibacterial agent. Chemically Levofloxacin is a chiral fluorinated carboxyquinolone. Indications Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae or Moraxella catarrhalis. Community acquired pneumoniae due to Staphylococcus aureus , Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae. Complicated urinary tract infections due to E. coli, Klebsiella pneumoniae or Staphylococcus saprophyticus. Acute pyelonephriits caused by E. coli. Uncomplicated and complicated skin and skin structure infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis. Dosage and Administration Acute sinusitis : 500 mg once daily for 10-14 days. Exacerbation of chronic bronchitis : 250-500 mg daily for 7-10 days. Community acquired penumonia : 500 mg once or twice daily for 7-14 days. Complicated urinary- tract infections and acute pyelonephritis : 250 mg daily for 7-10 days. Uncomplicated skin and soft-tissue infections : 500 mg once daily for 7-10 days. Complicated skin and soft-tissue infections : 750 mg once daily for 7-14 days. Contraindication Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this products. Precaution While taking Levofloxacin adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be taken during 166

Levofloxacin ingestion in presence of renal insufficiency and hepatic insufficiency. Side Effects Levofloxacin is generally well tolerated. However, a few side effects can usually be seen. Side effects include nausea, vomiting, diarrhoea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side effects that may be seen very rarely include tremors, depression, anxiety, confusion etc. Use in Pregnancy and Lactation Levofloxacin is not recommended for use during pregnancy or during lactation, as the effects on the unborn child or nursing infant are unknown. Use in Children Not recommended for children. Drug Interactions Antacids, Iron and multivitamin preparations with Zinc- reduce absorption of Levofloxacin. NSAIDs may increase the risk of CNS stimulation and convulsive seizures. Warfarin may increase the risk of bleeding. Overdosage Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained. Pharmaceutical Precaution Store in a cool and dry place, away from sunlight. Commercial Pack Evo 250 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each film coated tablet contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin-250 mg. Evo 500 Tablet : Box containing 20 tablets in 2 x 10s blister strips. Each film coated tablet contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 500 mg. 167

Fertil
Tablet

Description Fertil (Clomiphene Citrate USP) is an orally administered, non-steroidal, ovulatory stimulant. Each tablet contains Clomiphene Citrate USP 50 mg. Clomiphene Citrate is the first non-steroid preparation that in many patients induces ovulation which has failed. Clomiphene Citrate stimulates the increased secretion of both gonadotropins (FSH and LH), which induce the maturation of the ovarian follicle, ovulation and the subsequent normal function of the corpus luteum. It is most probably that Clomiphene Citrate stimulates the production of the releasing factor for gonadotropins in the hypothalamus, that induce the increasing secretion of FSH and LH. After oral administration, Clomiphene Citrate is readily absorbed from the gastrointestinal tract. Biological half-life in the plasma is 5-7 days. It is partly metabolized in the liver, and through the bile is excreted in the faeces. A part is reabsorbed and enters the enterohepatic recirculation pool. Indications Fertil is indicated for the treatment of ovulatory failure in women desiring pregnancy whose partners are fertile and potent. The following syndromes are most commonly associated with ovulatory failure: polycystic ovary syndrome, amenorrhoea with galactorrhoea, psychogenic amenorrhoea, some forms of secondary amenorrhoea of undetermined etiology, and post-oral-contraceptive amenorrhoea. Other possible causes of infertility should be excluded before giving Clomiphene Citrate. Fertil is indicated in the treatment of menorrhagia caused by hyperplastic endometrium. Dosage and Administration The usual dose for the first course of Fertil is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does 168

not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Fertil are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined. Contraindication Fertil is contraindicated during pregnancy, in patients with liver disease, ovarian cysts, bleeding of undetermined origin, and in patients with neoplasms of endometrium. Side Effects Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued. Precautions Clomiphene Citrate is not to be used for longer maintenance therapy. If ovarian enlargement occurs, the next Fertil course is not to be given until the ovaries return to their pretreatment size and the dosage of the next course may be reduced. Fertil should be used with caution with alcoholic drinks and antidepressants. There is a minimal chance of multiple pregnancies, about which the patient should be warned. Drug Interactions There are no significant drug interactions with Clomiphene Citrate. Use in Pregnancy and Lactation Fertil should not be administered during pregnancy. It is not known whether Fertil is excreted in human milk. Because many drugs are

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excreted in human milk, caution should be exercised if Fertil is administered to a nursing woman. In some patients, Fertil may reduce lactation. Pharmaceutical Precaution Tablets should be stored below 25 oC and protected from light and moisture. Commercial Pack Fertil Tablet : Box containing 50 tablets in blister strip. Each tablet contains Clomiphene Citrate USP 50 mg.

170

Fibril
Capsule

Description Fibril containing Gemfibrozil is an antilipemic agent. Gemfibrozil decreases serum triglycerides in healthy individuals and in patients with hypertriglyceridemia. It decreases very low density lipoprotein (VLD)triglyceride concentration. HDL-triglyceride usually decreases slightly. Gemfibrozil usually increases the HDL-cholesterol fraction in healthy individuals and in patients with hyperlipoproteinemia, an action that may be beneficial in slowing the progression of atherosclerosis and in reducing the risk of coronary heart disease. Gemfibrozil also inhibits synthesis of VLDL carrier apolipoprotein B, leading to a decrease in VLDL production. The drug inhibits lipolysis of fat in adipose tissue and decreases the hepatic uptake of plasma free fatty acids, thereby reducing hepatic triglyceride production. Gemfibrozil is rapidly and completely absorbed from the Gastrointestinal tract. Peak concentration in plasma occurs within 1 to 2 hours; the half-life is about 1.5 hours. About 70% of a dose is excreted in the urine little is excreted in the faeces. Indications Fibril is used as a hypolipidaemic agent in conjunction with dietary modification. It is recommended in the treatment of type IIa, type III, type IV, and type V hyperlipoproteinaemia. Dosage and Administration The usual dose, by mouth is 1.2g daily in 2 divided doses given 30 minutes before morning and evening meal. The dosage range may vary between 0.9-1.5g daily or as advised by the physician. Contraindication It is contraindicated in case of alcoholism, hepatic impairment, gallstone, pregnancy and in patients hypersensitive to Gemfibrozil.

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Precaution Risk benefit must be considered in case of lactating mother. Before initiating long term treatment lipid profile, blood counts, renal activity, annual eye examination and liver function test should be done. Side Effects The most frequent adverse effect involves the Gastro-intestinal tract. Abdominal pain and epigastric pain or dyspepsia are common adverse Gastro-intestinal effects. Other adverse reactions include pruritus, rash, headache, dizziness, blurred vision, painful extremities and rarely myalgia. Commercial Pack Fibril Capsule : Box containing 3x10 capsules in strip pack. Each capsule contains Gemfibrozil USP 300 mg.

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Filmet
Tablet/Suspension

Description Filmet is the brand of Metronidazole in 200, 400 and 800 mg film coated tablets and lemon flavoured suspension. The special film coating is to mask the characteristic bitterness of Metronidazole which may sometimes cause nausea. Filmet has antiprotozoal action and is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia intestinalis and anaerobic bacteria. Indications - Urogenital trichomoniasis in the female and male - Intestinal and extra-intestinal amoebiasis - Giardiasis - Anaerobic bacterial infections - Non-specific vaginitis - Anaerobically-infected ulcers and pressure sores Dosage and Administration
Indications Amoebic dysentery Asymptomatic amebiasis Hepatic and extraintestinal amebiasis Giardiasis Trichomoniasis consort treatments recommended Vincents infection Anaerobic infection Non-specific vaginitis Leg ulcer and pressure sore Duration Adults and Children Children in days over 10 years 7-10 yrs. 5 to 10 or 2 5 to 10 5 to 10 or 2 3 7 or 2 or 1 3 7 7 1 7 800 mg tid 2 g once daily 400-800 mg tid 400-800 mg tid 2-2.4 g once daily 2 g once daily 200 mg tid 800 mg-morning and 1.2 g-evening 2 g single dose 200 mg tid or 400 mg bid 400 mg tid 400 mg tid 2 g single dose 400 mg tid 400 mg tid 200-400 mg tid 200-400 mg tid Children 3-7 yrs. 200 mg qid 100-200 mg qid. 100-200 mg tid Children 1-3 yrs. 200 mg tid 100-200 mg t.i.d 100-200 mg t.id

1 g once daily 100 mg t.id

600 mg once daily 100 mg bid

500 mg once daily 50 mg tid

100 mg tid

100 mg tid

50 mg tid

7.5 mg/kg body weight in divided doses

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Side Effects Side effects of Metronidazole include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy. Precautions Metronidazole should not be used in patients with blood dyscrasia. It is suggested that it should not be given in the first three months of pregnancy. When given in conjunction with alcohol, Metronidazole may provoke a disulfiram like effect. Contraindication Filmet is contraindicated in patients with prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives. Commercial Pack Filmet 200 Tablet : 10 blister strips of 10 film coated tablets, each tablet contains 200 mg Metronidazole BP. Filmet 400 Tablet : 10 blister strips of 10 film coated tablets, each tablet contains 400 mg Metronidazole BP. Filmet DS Tablet : 10 blister strips of 10 film coated tablets, each tablet contains 800 mg Metronidazole BP. Filmet Suspension : 60 ml suspension in amber glass bottle, each 5 ml contains Metronidazole Benzoate BP 320 mg equivalent to 200 mg Metronidazole.

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Flatameal-DS
Tablet/Suspension

Description Flatameal -DS is an antacid and antiflatulent containing a combination of Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and Simethicone USP. Indications Flatameal-DS is indicated for dyspepsia, hyperacidity, gastric and duodenal ulcer, gastritis; also indicated for the relief of flatulence, abdominal distention and windy colic. Dosage and Administration 1-2 tablets of Flatameal-DS to be chewed or 1-2 teaspoonful of Flatameal-DS Suspension to be taken one hour after meals and at bed time or as directed by the physician. Precautions - Drugs containing Aluminium Hydroxide should not be taken concomitantly with any form of Tetracycline, as the absorption of the later may be affected. - Aluminium Hydroxide may also reduce the absorption of Digoxin. Commercial Pack Flatameal-DS Tablets : Box containing 20 blister strips of 10 tablets, each tablet contains 400 mg dried Aluminium Hydroxide Gel USP, 400 mg Magnesium Hydroxide BP and 30 mg Simethicone USP. Flatameal-DS Suspension : 200 ml suspension in glass bottle, each 5 ml contains Aluminium Hydroxide Gel USP equivalent to 200 mg Aluminium Oxide, 400 mg Magnesium Hydroxide BP and 30 mg Simethicone USP.

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Flubex
Capsule/Syrup

Description Flubex is a preparation of Flucloxacillin. It acts in similar way to Penicillin by inhibiting bacterial cell wall synthesis. Indications Flubex is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by -lactamase producing staphylococci. Typical indications include: Respiratory tract infections : Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis. Skin and soft tissue infections : Boils, abscesses, carbuncles, furunculosis, infected skin conditions e.g. ulcer, eczema, acne, cellulitis, infected wounds, infected burns etc. Other infections caused by Flucloxacillin-sensitive organisms : Osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia. Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures where appropriate; for example, cardiothoracic and orthopaedic surgery. Dosage and Administration Doses should be administered half an hour before meals. Adult (including elderly patients) : 250 mg four times daily. Dose may be increased in severe infections. In osteomyelitis, endocarditis- up to 8 g daily, in divided doses six to eight hourly. Children : 2-10 years- half of adult dose; Under 2 years- one fourth of adult dose.

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Contraindication Flucloxacillin is contraindicated for those who have hypersensitivity to penicillins. Use in Pregnancy and Lactation Animal studies with Flucloxacillin have shown no teratogenic effects. The use of Flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician. Side Effects Side effects, as with other penicillins, are uncommon and mainly of mild and transitory in nature. Gastrointestinal upsets (e.g. nausea, diarrhoea) and skin rashes have been reported. If a skin rash occurs, treatment should be discontinued. Hepatitis and cholestatic jaundice have been rarely reported. Overdosage Problems of overdosage with Flucloxacillin are unlikely to occur. In case of overdosage patient should be treated symptomatically. Pharmaceutical Precaution Store in a cool and dry place. Keep out of the reach of children. Commercial Pack Flubex-250 Capsule : Box containing 5 strips of 10 capsules. Each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg. Flubex-500 Capsule : Box containing 3 strips of 10 capsules, each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg. Flubex Powder for Syrup : Dry powder in amber glass bottle for reconstitution into 100 ml syrup. After reconstitution, each 5 ml contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 125 mg.

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FormulaE
Tablet

Description Formula-E (Vitamin E) is a crackable tablet with chocolate taste. Each tablet contains Vitamin E USP (dl-alpha tocopheryl acetate) 200 mg. Indications As a dietary supplement and for prophylactic use : To meet raised requirements (e.g. pregnancy and lactation period, high dietary intake of polyunsaturated fatty acids, etc).

For prevention of vitamin E deficiency due to malabsorption syndromes caused by pancreatic, hepatobiliary and gastrointestinal disorders.

Therapeutic use : Haemolytic anaemia due to vitamin E deficiency (in premature infants).

Intermittent claudication.

Also Formula-E has been found to be effective in preventing and alleviating the symptoms of the following conditions :In internal medicine : Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency, fibrositis, Dupuytrens contracture, Peyronies disease, male infertility, dyslipoproteinaemia with low HDL cholesterol and high LDL cholesterol. In gynaecology and obstetrics : Habitual abortion, tendency to premature delivery, habitual stillbirth, threatened abortion, menopausal disorders, pruritus vulvae, kraurosis vulvae. In dermatology : Lupus erythematosus, granuloma annulare, acrodermatosis, atrophicans progressiva, scleroderma. Dosage and Administration Dosage varies according to individuals need. The following dosages are recommended in different indications. 178

As a supplement or prophylactic use: Increased requirements: 100-300 mg daily Malabsorption syndromes: 100-300 mg daily Haemolytic anaemia in premature infants: 100-200 mg/kg body weight Intermittent claudication: 300-600 mg daily. Other indications and dosages are the following: Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency : 300-600 mg daily Fibrositis, Dupuytrens contracture, Peyronies disease, dyslipoproteinaemia with low HDL cholesterol and high LDL cholesterol. : 200-300 mg daily Male infertility : 100-200 mg daily Habitual abortion, tendency to premature delivery, habitual stillbirth : 100 mg daily from the beginning of pregnancy as a prophylaxis, with hormone therapy if required Threatened abortion : 100 mg every 6 hours until the crisis is over Menopausal disorders, pruritus vulvae, kraurosis vulvae : 100-200 mg daily Lupus erythematosus, granuloma annulare, acrodermatosis, dermatitis atrophicans diffuse progressiva, scleroderma : 100-300 mg daily. Side Effects Vitamin E is very well tolerated. As a rule, daily doses of up to 800 mg do not induce any adverse reactions. Only a dose approaching 1 g may give rise to transient gastrointestinal symptoms like nausea, flatulence, diarrhoea, etc. There have so far been no reports of any changes in laboratory parameters as a result of vitamin E administration. Contraindication There is no absolute contraindication. Warning and Precautions Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. Use in Pregnancy and Lactation Vitamin E may be used in pregnancy in the normally recommended dose, 179

but the safety of high-dose therapy has not been established. There appears to be no contraindication to breast feeding by mothers taking the normally recommended dose. Drug Interactions In animal studies very high doses of vitamin E were shown to limit the absorption of vitamin A and K. Overdosage Vitamin E hypervitaminosis is unknown. Commercial Pack Formula-E Tablet : Bottle containing 15 tablets. Each tablet contains Vitamin E USP (dl-alpha tocopheryl acetate) 200 mg.

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Frelax
Powder

Description Frelax (Polyethylene Glycol USP) is a powder for solution and is a synthetic polyglycol having an average molecular weight of 3350. Below 55C it is a free flowing white powder freely soluble in water. It is an osmotic agent for the treatment of constipation. Indications Frelax is indicated for the treatment of constipation. This product should be used for 2 weeks or less or as directed by a physician. Dosage and Administration The usual dose of Frelax is 17 g (about 1 heaping tablespoon) of powder per day (or as directed by physician) in 8 ounces (approximately 240 ml, one glass) of water, juice, coke, coffee, or tea. Side Effects Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhoea and excessive stool frequency, particularly in elderly patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction. Contraindication Frelax is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol. Precautions General: Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defaecating and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary

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fiber and fluid intake, regular exercise) which may produce more regular bowel habits. Polyethylene glycol should be administered after being dissolved in approximately 8 ounces of water, juice, coke, coffee, or tea. Pediatric : Safety and effectiveness in pediatric patients has not been established. Geriatric : There is no evidence for special considerations when Polyethylene glycol is administered to elderly patients. In geriatric nursing home patients a higher incidence of diarrhoea occurred at the recommended 17 g dose. If diarrhoea occurs Polyethylene glycol should be discontinued. Use in Pregnancy and Lactation Pregnancy Category C : Animal reproductive studies have not been performed with polyethylene glycol. It is also not known whether Frelax can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. Frelax should only be administered to a pregnant woman if clearly needed. There is no information on the use of polyethylene glycol while nursing. Consultation with a physician is necessary in case of breast feeding. Drug Interactions No specific drug interactions have been demonstrated. Overdosage There have been no reports of accidental overdose. In the event of overdose diarrhoea would be the expected major event. Dehydration may occurred. Medication should be terminated immediately and plenty of fluids should be administered. Information to the Patient Frelax is a prescription only laxative that has been prescribed by physician to treat constipation. The person for whom it is prescribed should only use this product.

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How to take? The dose of Frelax is 17 g each day or as directed by physician. It should always be taken by mouth. Measure the dose using the supplied cap, stir and dissolve in a glass (8 ounces or 240 ml) of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhoea. Each bottle is supplied with a measuring cap that is used to measure 17 g or 8.5 g of laxative powder when filled up to the indicated line. How long should it be taken? Frelax achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating or diarrhoea occur, consultation with physician is needed. Frelax is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the Frelax therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise). Commercial Pack Frelax Powder : Each bottle contains 85 g of Polyethylene Glycol 3350 USP NF powder for solution. The cap on each bottle is marked with a measuring line and may be used to measure a single dose of 17 g or 8.5 g of powder for reconstitution into solution. After reconstitution 240 ml solution contains 17 g of Polyethylene Glycol.

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Frenxit
Tablet

Description Frenxit is a preparation of Flupentixol and Melitracen. Flupentixol- is a neuroleptic with anxiolytic and antidepressant properties when given in small doses, and Melitracen- a bipolar thymoleptic with activating properties in low doses. In combination the compound renders a preparation with antidepressant, anxiolytic and activating properties. Indications Anxiety Depression Apathy. Others are- Psychogenic depression, Depressive neuroses, Masked depression, Psychosomatic affections accompanied by anxiety and apathy, Menopausal depression. Dysphoria and depression in alcoholics and drug addicts. Dosage and Administration Adults: Usually 2 tablets daily (morning and noon). In severe cases the morning dose may be increased to 2 tablets. Elderly patients: 1 tablet in the morning. Maintenance dose: Usually 1 tablet in the morning. In cases of insomnia or severe restlessness additional treatment with a sedative in the acute phase is recommended. Second dose should not be taken after 4 pm. Contraindication The immediate recovery phase after myocardial infarction. Defects in bundle-branch conduction. Untreated narrow angle glaucoma. Acute alcohol, barbiturate and opiate intoxication. Flupentixol and Melitracen should not be given to patients who have received a MAO-inhibitor within two weeks. Not recommended for excitable patient since its activating effect may lead to exaggeration of these characteristics. Precautions If previously the patient has been treated with tranquilizers with sedative effects these should be withdrawn gradually.

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Use in Pregnancy and Lactation Flupentixol and Melitracen should preferably not be given during pregnancy and lactation. Side Effects In the recommended doses side effects are rare. These could be transient restlessness and insomnia. Drug Interactions Flupentixol and Melitracen may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crisis. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline. Overdosage Symptoms : In cases of overdosage the symptoms of intoxication by Melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to Flupentixol occur. Treatment : It should be symptomatic and supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with Diazepam and extrapyramidal symptoms with Biperiden. Commercial Pack Frenxit Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each film coated tablet contains Flupentixol Dihydrochloride BP equivalent to 0.5 mg Flupentixol and Melitracen Hydrochloride INN equivalent to 10 mg Melitracen.

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Fungistin
Suspension

Description Fungistin oral suspension is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Fungistin oral suspension is banana flavoured, ready to use suspension containing 100,000 units of Nystatin BP per ml. Indications Suspension for the prevention and treatment of candidal infection of the oral cavity, oesophagus and intestinal tract caused by Candida albicans (monilia) it provides effective prophylaxis against oral candidiasis in those born of mothers with vaginal candidiasis. Dosage and Administration Adults: Dosage range: 1-6 ml four times daily. For the treatment of denture sores, and oral infections, in adults caused by C. albicans, 1-2 ml of the suspension should be dropped into the mouth four times daily, it should be kept in contact with the affected area as long as possible. Older people with intestinal candidiasis may be given 5 ml of the suspension four times a day. Children: Dosage range:

1-6 ml four times daily in children 1-2 ml four times daily infants

In intestinal and oral candidiasis (thrush) in infants and children, 1-2 ml should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater will be its effect. 186

For prophylaxis of oral candidiasis in the newborn the suggested dose is 1 ml once daily. Administration should be continued for 48 hours after clinical cure to prevent relapse. Contraindication There are no known contraindication to the use of Nystatin except hypersensitivity to the drug. Precautions Use in pregnancy: Absorption of Fungistin from the gastrointestinal tract is negligible, therefore no special precautions apply in pregnancy. Side Effects Nausea, vomiting and diarrhoea have occasionally been reported with doses of Nystatin exceeding 4 to 5 million units daily. No systemic effects or allergic reactions have been associated with its oral use. Overdosage Since the absorption of Nystatin from the gastro-intestinal tract is negligible, overdosage causes no systemic toxicity. Pharmaceutical Precaution Dilution : Not recommended as this may reduce therapeutic efficacy. Commercial Pack Fungistin Oral Suspension : 12 ml suspension in amber glass bottle with graduated dropper, each ml contains 100,000 units of Nystatin BP.

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Furasep
Cream

Description Furasep cream is a preparation of 0.2% Nitrofurazone. Nitrofurazone is a broad spectrum topical antibacterial agent indicated for the treatment of mixed skin infections of superficial wounds and diseases of the skin. Indications Furasep is indicated in the infectious conditions of the skin such as burns, wounds, ulcers, skin infections and skin grafting. Dosage and Application To be applied directly to the lesion or on gauze first; 2-3 times daily or as advised by the physician. Side Effects Sensitization and generalized allergic skin reactions may be produced after few days of initial application. Cross sensitization to other Nitrofurazone derivatives may occur. Intolerance to Nitrofurazone necessitating withdrawal has been encountered. Contraindication and Warning Furasep is contraindicated to patients with known sensitivity to Nitrofurazone. It is not advisable to use Furasep after the infection is cured. It should be used with caution in patients with known or suspected renal impairment. Commercial Pack Furasep Cream : Tube containing 20 g cream, each gram contains Nitrofurazone USP 2 mg.

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Fusidic Plus
Ointment

Description Fusidic Plus is a topical steroid-antibiotic ointment. It contains Sodium Fusidate BP 2% and Hydrocortisone Acetate BP 1%. Indications Eczema and dermatitis with secondary bacterial infections, including atopic eczema, primary irritant dermatitis and allergic and seborrhoeic dermatitis where the organisms are known to be or believed to be sensitive to Fusidic Acid. Dosage and Application Adults and Children : Uncovered lesions- apply gently 3 to 4 times daily. Covered lesions - less frequent applications may be adequate. Contraindication Contraindicated in patients with hypersensitivity to Fusidic Acid or its salts. Also contraindicated in cases of primary bacterial, viral and fungal infections. Precautions As with all topical antibiotics, bacterial resistance and contact sensitization may occur. These risks may increase with extended or recurrent application. Caution should be exercised when used near the eye. Steroidantibiotic combinations should not be used for more than seven days without clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions. Long-term continuous use should be avoided in infants, and adrenal suppression can occur. Use in Pregnancy and Lactation There is inadequate evidence of safety in pregnancy and nursing mothers. Use requires benefit to be weighed against possible hazards to the foetus.

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Side Effects Hypersensitivity reactions in the form of skin rashes and mild stinging irritation on application have been reported rarely. Commercial Pack Fusidic Plus Ointment : It is supplied in aluminium tube of 10 g and 20 g capacity. Each gram of Fusidic Plus ointment contains Sodium Fusidate BP 20 mg and Hydrocortisone Acetate BP 10 mg.

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Gastalfet
Tablet

Description Gastalfet tablet contains 500 mg of Sucralfate (basic aluminium salt of sucrose octa sulphate). Indications For the treatment of duodenal ulcer, gastric ulcer and chronic gastritis. Dosage and Administration Adult: Usual dose 1 gram 4 times daily to be taken 1 hour before meals and at bed time. Maximum daily dose is 8 grams. Four to six weeks treatment is usually needed for ulcer healing but up to twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Gastalfet. Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used. Safety and efficacy in children have not been established. Contraindication There are no known contraindication. Precautions The product should only be used with caution in patients with renal dysfunction. Use in Pregnancy and Lactation Although animal studies show no evidence of foetal malformation, safety in pregnant women has not been established and Gastalfet should be used in pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be taken when Sucralfate is administered to nursing mothers.

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Drug Interaction Concomitant use of Sucralfate may reduce the bioavailability of certain drugs as has been observed in animal studies with Tetracycline, Phenytoin and Cimetidine and in human studies with Digoxin. Administration of Gastalfet with any of these drugs should be separated by two hours. Since Sucralfate may hinder Warfarin absorption, caution should be taken when these two drugs are used together. Side Effects The incidence and severity of side effects from Sucralfate are very low. Mild side effect like constipation has been reported in some patients. Overdosage There is no experience in human with overdosage. Commercial Pack Gastalfet Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains Sucralfate USP 500 mg.

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Gentosep
Cream

Description Gentosep is a preparation of Gentamicin Sulphate which is a water soluble antibiotic of the aminoglycoside group, active against a wide variety of pathogenic Gram-positive and Gram-negative microorganisms. Indications Gentosep cream is indicated for the topical treatment of the primary and secondary bacterial infections of the skin caused by the organisms sensitive to Gentamicin. Gentosep may clear infections that have not responded to other topical antibiotics. Dosage and Application A small amount of Gentosep should be applied gently to the affected areas three to four times daily. The area treated may be covered with a gauze dressing if desired. Before applying the medication the affected area should be properly cleaned. Side Effects Gentosep cream is well tolerated. There has been no evidence of irritation and sensitization after using Gentosep cream. Contraindication Gentosep is contraindicated in individuals with a history of hypersensitivity to any of its components. Precautions Use of topical antibiotics occasionally cause overgrowth of nonsusceptible organisms including fungi. If this occurs or if irritation, sensitisation or super infection develops, treatment with Gentosep should be discontinued and appropriate therapy should be instituted. Commercial Pack Gentosep Cream : Each gram contains Gentamicin Sulphate BP equivalent to 3 mg Gentamicin base in sealed tubes of 15 grams. 193

HefolinSR
Capsule

Description Each Hefolin sustained release capsule contains 150 mg Ferrous Sulphate BP equivalent to 47 mg Iron and 500 g of Folic Acid BP. Hefolin SR is a transparent capsule filled with colourful pellets. The iron is specially formulated for sustained release over a period of several hours. Indications Hefolin SR capsule is a haematinic preparation indicated in the treatment of iron and folic acid deficiency states. Hefolin SR is used as a prophylaxis of iron deficiency in pregnancy and after subtotal or total gastrectomy. Dosage and Administration As a Prophylaxis Adult : One capsule daily. In more severe cases, two capsules a day may be required or as prescribed by the physician. In Elderly patient same as adult dose. Children aged over 1 year : One capsule a day, the capsule may be opened and the pellets mixed with soft cool food but they must not be chewed. As a Treatment 2 to 4 capsules a day or as prescribed by the physician. Contraindication It is contraindicated in patients with hypersensitivity to any of its components. Precautions Caution should be taken in patients with haemochromatosis, haemolytic anaemia or red cell aplasia as they may cause high blood iron concentrations. In case of pregnant women and lactating mothers, it is better to seek the advice of a health professional before using this product.

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Drug Interactions Iron chelates with Tetracycline. Since oral Iron products interfere with absorption of oral tetracycline antibiotics, these product should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. Side Effects Although Hefolin SR capsule is designed to minimize gastrointestinal side effects, in some cases anorexia, nausea, abdominal discomfort, constipation may be encountered. Overdosage Gastric lavage should be carried out in the early stages and vomiting may also be induced if needed. Oral Desferrioxamine (2 g for a child and 5 g for an adult) should be given. If the patient is in shock or coma Desferrioxamine should be administered by IV or IM route. Pharmaceutical Precaution Keep in a cool and dry place below 25o C and protect from sunlight. Keep out of reach of children. Commercial Pack Hefolin SR Capsule : Box containing 10 x 10s blister strips. Each capsule contains 150 mg Ferrous Sulphate BP equivalent to 47 mg Iron and 500 g Folic Acid BP.

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Inarzin
Tablet

Description Inarzin is a preparation of Cinnarizine which acts as an antihistamine, labyrinthine sedative and a peripheral antivasoconstrictor. Each tablet contains Cinnarizine BP 15 mg. Mode of Action Inarzin (Cinnarizine) is a selective calcium antagonist, inhibiting the influx of Ca2+ intracellularly. It prevents the Ca 2+-dependent contraction of arterial smooth muscle by inhibiting Ca 2+ influx through smooth muscle calcium channels and thereby, improves vestibular symptoms and prevents peripheral arterial disease. Indications Inarzin is indicated for : - The control of vestibular symptoms such as vertigo, tinnitus, nausea and vomiting as seen in Menieres disease - The prophylaxis and control of motion sickness - The long-term treatment of peripheral arterial disease Dosage and Administration The recommended dose for treatment of vestibular symptoms in adults and children over 12 years is 30 mg (2 tablets) three times daily. For children from 5 to 12 years half the adult dose is recommended, i.e. 15 mg (1 tablet) three times daily. For prophylaxis of motion sickness, 30 mg (2 tablets) should be taken 2 hours before travel and then 15 mg (1 tablet) every 8 hours during the journey. Children from 5 to 12 years, should take half the adult dose. In the management of peripheral arterial disease, the recommended starting dose is 75 mg (5 tablets) three times daily. Maintenance dose is 75 mg (5 tablets) two to three times daily depending upon the therapeutic response. Inarzin should preferably be taken after meals.

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Contraindication - Known hypersensitivity to Cinnarizine - Parkinsons disease - Hypotension Side Effects Drowsiness and gastrointestinal disturbances may occur. These are usually transient. In rare cases, headache, dry mouth, etc. may occur. Drug Interaction Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Cinnarizine. Therefore, it is advisable to avoid these drugs while taking Cinnarizine. Use in Special Population Neonates : Cinnarizine is not indicated in neonates Pregnant women : The safety of Cinnarizine in human pregnancy has not been established. Therefore, it is not advisable to administer Cinnarizine in pregnancy. Nursing mothers : It is not known if Cinnarizine is excreted in human breast milk. Use of Cinnarizine during breast-feeding is not advised. Overdosage Vomiting, drowsiness, tremor, etc. may occur. There is no specific antidote to Cinnarizine, but in the event of overdosage, gastric lavage and the administration of activated charcoal may help. Pharmaceutical Precaution Store at room temperature. Commercial Pack Inarzin Tablet : Box containing 100 tablets in 10 x 10s blister strips, each tablet containing Cinnarizine BP 15 mg.

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Informet LA
Tablet Description Informet LA (Metformin Hydrochloride) belongs to biguanide class of oral antidiabetic drugs. It decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity. Unlike sulfonylureas, Metformin does not produce hypoglycaemia. It is the drug of first choice in obese patients. Indications Metformin Hydrochloride, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycaemia cannot be satisfactorily managed on diet alone. Metformin Hydrochloride may use concomitantly with a sulfonylurea when diet and Metformin Hydrochloride or sulfonylureas alone do not result in adequate glycaemic control. Dosage and Administration The usual starting dose of Informet LA (Metformin Hydrochloride long acting) is 500 mg once daily with the evening meal. Dose increments should be made 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycaemic control is not achieved on Informet LA 2000 mg once daily, a trial of Informet LA 1000 mg twice daily should be considered. When transferring patients from standard oral hypoglycaemic agents other than Chlorpropamide to Metformin HCl, no transition period generally is necessary. When transferring patients from Chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of Chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycaemia. Side Effects Diarrhoea, nausea, vomiting, abdominal bloating, flatulence, and anorexia are the most common side effects to Metformin Hydrochloride. Lactic acidosis also rarely occurs.

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Contraindication Metformin Hydrochloride is contraindicated in patients with renal disease or renal dysfunction, congestive heart failure, known hypersensitivity, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Precautions Metformin Hydrochloride therapy should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids) and should not be restarted until the patients oral intake has resumed and renal function has been evaluated as normal. It should be used with caution in case of excessive alcohol intake and hepatic insufficiency. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. Use in Special Population Pregnancy : Safety in pregnant women has not been established. Any decision to use this drug should be balanced against the benefits and risks. Nursing Mothers : It is not known whether Metformin Hydrochloride is secreted in human milk. Paediatric and Geriatric use : Safety and effectiveness in paediatric patients have not been established. Dosage adjustment should be based on a careful assessment of renal function in elderly patients. Drug Interactions Nifedipine : Nifedipine appears to enhance the absorption of Metformin. Metformin has minimal effects on Nifedipine. Others : Certain drugs tend to produce hyperglycaemia and may lead to loss of glycaemic control. These drugs include thiazide and other diuretics, corticosteroids, phenothiazines, oestrogens, oral contraceptives, Phenytoin, Nicotinic acid, sympathomimetics, calcium channel blocking drugs, and Isoniazid. When such drugs are administered to a patient receiving Metformin HCl, the patient should be closely observed to maintain adequate glycaemic control.

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Overdosage Hypoglycaemia has not been seen even with ingestion of up to 85 grams of Metformin HCl, although lactic acidosis has occurred in such circumstances. Haemodialysis may be useful for removal of accumulated drug from patients in whom Metformin overdosage is suspected. Pharmaceutical Precaution Store at 15 0-25 0 C. Keep in a cool and dry place. Keep out of the reach of children. Commercial Pack Informet LA Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each long acting tablet contains Metformin Hydrochloride BP 500 mg.

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Intracef
Capsule/Suspension/Paediatric Drops

Description Intracef (Cephradine) is a semisynthetic first generation cephalosporin antibiotic that works in a similar way to penicillin by inhibiting bacterial cell wall synthesis. The chemical name of Cephradine is [6R-[6 , 7 (R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid. Indications Intracef is a broad spectrum bactericidal antibiotic active against both Gram-positive and Gram-negative bacteria. It is also highly active against most strains of penicillinase-producing staphylococci. Intracef is indicated for the treatment of the following infections when caused by susceptible organisms.

The upper and lower respiratory tract infections - pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronic bronchitis, lobar pneumonia Gastrointestinal tract infections Urinary tract infections- cystitis, urethritis, pyelonephritis Skin and soft tissue infections- abscess, cellulitis, furunculosis and impetigo Prophylaxis for surgical procedures associated with high risk of disastrous consequences of infection.

Intracef is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection. Protection is best ensured by achieving adequate local tissue concentrations at the time of contamination is likely to occur. Thus, Intracef should be administered immediately prior to surgery and continued during the postoperative period. 201

Dosage and Administration Intracef may be given regardless of meals. Adults : For urinary tract infections the usual dose is 500 mg four times daily or 1 g twice daily; severe or chronic infections may require larger dose. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections and skin and soft tissue infections the usual dose is 250 mg or 500 mg four times daily or 500 mg or 1g twice daily depending on the severity and site of infection. Children : The usual dose is from 25 to 50 mg/kg/day total, given in two or four equally divided doses. For otitis media daily dose from 75 to 100 mg/kg body weight in divided doses every 6 to 12 hours are recommended. Maximum dose is 4 g per day. Elderly : There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic function. Dosage in renal impairment : A modified dosage schedule is necessary in patients with decreased renal function. Each patient should be considered individually; the following modified dosage schedule is recommended as a guideline, based on the creatinine clearance (ml/min/1.73m2 ). In adults, the initial loading dose is 750 mg of Intracef and the maintenance dose is 500 mg at the time intervals listed below : Creatinine clearance More than 20 ml/min 15-19 ml/min 10-14 ml/min 5-9 ml/min Less than 5 ml/min Time interval 6-12 hours 12-24 hours 24-40 hours 40-50 hours 50-70 hours

Further modification of the dosage schedule may be necessary in children.

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Side Effects Rarely Cephradine may induce a hypersensitivity reaction and gastrointestinal disturbances which include nausea, vomiting, diarrhoea, glossitis, heartburn, dizziness, abdominal pain, candidal overgrowth, vaginitis, urticaria, skin rashes, joint pain and oedema. As with other cephalosporins, mild transient eosinophilia, leucopenia and neutropenia, rarely positive direct Coombs test and pseudomembraneous colitis have been reported. Drug Interactions The cephalosporins are potentially nephrotoxic (particularly Cephaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as Gentamicin and Tobramycin. One should be cautious about the use of any cephalosporin with Frusemide and Ethacrynic Acid. Use in Pregnancy and Lactation No teratogenicity has been demonstrated in animals, but safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Contraindication Patients with known hypersensitivity to cephalosporin antibiotics. Warning and Precautions There is evidence of partial cross-allergenicity between penicillins and the cephalosporins. Therefore Cephradine should be used with caution in patients with known hypersensitivity to penicillins. Commercial Pack Intracef 250 Capsule : Box containing 5 x 10s blister strips. Each capsule contains Cephradine BP 250 mg. Intracef 500 Capsule : Box containing 4 x 10s blister strips. Each capsule contains Cephradine BP 500 mg. Intracef Suspension : Each amber glass bottle contains dry powder for 100 ml suspension. After reconstitution each 5 ml contains Cephradine BP 125 mg. Intracef Paediatric Drops : Each amber glass bottle contains dry powder for 15 ml paediatric drops. After reconstitution each 1.25 ml contains Cephradine BP 125 mg. 203

Intracef
Injection

Description Intracef (Cephradine) is a semisynthetic first generation cephalosporin antibiotic that works in a similar way to penicillin by inhibiting bacterial cell wall synthesis. The chemical name of Cephradine is [6R-[6 , 7 (R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid. Indications Intracef is indicated for use primarily in the treatment of infections of the respiratory tract, genitourinary tract, soft tissue and skin, blood stream, and bones, caused by susceptible organisms as listed below: Staphylococcus aureus (penicillin sensitive and penicillinase producing strains); Group-A Beta-haemolytic streptococci; Pneumococci; Haemophilus influenzae; Escherichia coli and other coliform bacteria; Klebsiella species; Proteus mirabilis. Intracef is also effective in cases of peritonitis. Bacteriology studies to determine the causative organisms and their sensitivity to Cephradine should be performed. Therapy may be instituted prior to receiving the results of the sensitivity test. Intracef is effective prophylactically, to avoid infections due to susceptible organisms in patients about to undergo ceasarian section or vaginal hysterectomy. Intracef is primarily indicated for those patients unable to tolerate oral medication. It is also indicated for intravenous use either by direct intravenous injection or by intravenous infusion for the treatment of serious and life threatening infections. Intracef is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection. Thus, Intracef should be administered immediately prior to surgery and continued during the postoperative period.

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Dosage and Administration Adults: The usual dose of Intracef for injection is 2 to 4 g daily in four equally divided doses intramuscularly or intravenously (e.g. 500 mg to 1 g four times daily). A dosage of 500 mg four times a day is adequate in uncomplicated pneumonia, furunculosis with cellulitis, and most urinary tract infections. In severe infections, the dose may be increased by giving injections every four hours or by increasing the dose. The maximum dose should not exceed 8 g per day. The recommended dose for surgical prophylaxis is either a single 2 g dose given 1 hour before surgery or a regimen of 1 g given one hour before surgery followed by a second dose 4 hours later. Additional doses of 1 g may be given every 4 hours until vital signs are stabilized. Infants and Children: The usual dose range is 50 to 100 mg/kg/day in equally divided doses four times a day and should be regulated by age, mass of the patient, and severity of the infection being treated. Elderly : There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic function. Dosage in renal impairment : A modified dosage schedule is necessary in patients with decreased renal function. Each patient should be considered individually; the following modified dosage schedule is recommended as a guideline, based on the creatinine clearance (ml/min/1.73m2 ). In adults, the initial loading dose is 750 mg of Intracef (Cephradine) and the maintenance dose is 500 mg at the time intervals listed below : Creatinine clearance More than 20 ml/min 5-20 ml/min Less than 5 ml/min Dose 500 mg 250 mg 250 mg Time interval 6 hours 6 hours 12 hours

Further modification of the dosage schedule may be necessary in children

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Side Effects Rarely Cephradine may induce a hypersensitivity reaction and gastrointestinal disturbances which include nausea, vomiting, diarrhoea,glossitis, heartburn, dizziness, abdominal pain, candidal overgrowth, vaginitis, urticaria, skin rashes, joint pain and oedema. As with other cephalosporins, mild transient eosinophilia, leucopenia and neutropenia, rarely positive direct Coombs test and pseudomembraneous colitis have been reported. Drug Interactions The cephalosporins are potentially nephrotoxic (particularly cephaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramycin. One should be cautious about the use of any cephalosporin with frusemide and ethacrynic acid. Use in pregnancy and lactation No teratogenicity has been demonstrated in animals, but safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Contraindication Patients with known hypersensitivity to cephalosporin antibiotics. Warning and Precautions There is evidence of partial cross-allergenicity between penicillins and the cephalosporins. Therefore Cephradine should be used with caution in patients with known hypersensitivity to penicillins. Commercial Pack Intracef 250 Injection: Each box contains 10 combipacks. Each combipack contains 1 vial of Cephradine with Arginine equivalent to Cephradine USP 250 mg and 1 ampoule of 5 ml Water for Injection BP. Intracef 500 Injection: Each box contains 10 combipacks. Each combipack contains 1 vial of Cephradine with Arginine equivalent to Cephradine USP 500 mg and 1 ampoule of 5 ml Water for Injection BP.

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Ipramid
Inhaler Description Ipratropium Bromide BP, the active ingredient in Ipramid Inhaler, is an anticholinergic (parasympatholytic) agent that appears to inhibit vagallymediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. The bronchodilation following inhalation of Ipratropium Bromide is primarily a local, site-specific effect and not a systemic one. Indications Ipratropium Bromide inhaler administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Dosage and Administration Adults : 20-40 g, in early treatment up to 80 g at a time, 3-4 times daily. Children : up to 6 years 20 g 3 times daily, 6-12 years 20-40 g 3 times daily. Contraindication Ipratropium Bromide inhalation aerosol is contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soya bean and peanut. Ipratropium Bromide is contraindicated in known or suspected cases of hypersensitivity to Ipratropium Bromide, or to atropine and its derivatives.

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Precautions Ipratropium Bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Use in Pregnancy and Lactation Pregnancy Category B : Because animal reproduction studies are not always predictive of human response, Ipratropium Bromide should be used during pregnancy only if clearly needed. Nursing Mothers : It is not known whether Ipratropium Bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipratropium Bromide would reach the infant to a significant extent, especially when taken by inhalation since Ipratropium Bromide is not well absorbed systematically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when Ipratropium Bromide is administered to a nursing woman. Pediatric Use : Safety and effectiveness in children below the age of 12 have not been established. Side Effects General : Headache, pain, influenza-like symptoms, back pain, chest pain; Cardiovascular : Hypertension may be aggravated; Central and Peripheral Nervous System: Dizziness, insomnia, tremor, nervousness; Gastrointestinal : Mouth dryness, nausea, constipation; Musculo-skeletal System : Arthritis; Respiratory System (Upper) : pharyngitis, rhinitis, sinusitis; Respiratory System (Lower) : Coughing, dyspnoea, bronchitis, bronchospasm. Additional adverse reactions reported in less than three percent of the patients treated with Ipratropium Bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. A single case of anaphylaxis thought to be possibly related to Ipratropium Bromide has been reported. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported.

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Lower respiratory adverse reactions (bronchitis, dyspnoea and bronchospasm) were the most common events leading to discontinuation of Ipratropium Bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of Ipratropium Bromide equals or exceeds 2,000 g. Pharmaceutical Precaution Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30 0 C. Keep away from eyes. Keep away from children. Commercial Pack Ipramid Inhaler : Each canister contains 200 metered doses, each containing 20 g Ipratropium Bromide BP.

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Isofloxin
Tablet

Description Isofloxin is a film coated tablet. Each tablet contains Pefloxacin Mesilate BP equivalent to 400 mg Pefloxacin. Indications Isofloxin is indicated for the treatment of single or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including aminoglycoside, penicillin and cephalosporin. Isofloxin is indicated for the treatment of the following infections caused by sensitive bacteriaSevere systemic infection : Septicaemia, bacteraemia, peritonitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns. Urinary tract infection : Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis. Respiratory tract infection : Lobar and bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema. Gastrointestinal infection : Enteric fever, infective diarrhoea. Infections of the biliary system : Cholangitis, cholecystitis, empyema of the gall bladder. Skin and soft tissue infection : Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns. Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis, tonsillitis. 210

Intra abdominal infection : Peritonitis, intra abdominal abscesses. Bone and joint infection : Osteomyelitis, septic arthritis. Pelvic infection : Salpingitis, endometritis, pelvic inflammatory diseases. Gonorrhoea : Including urethral, rectal and pharyngeal gonorrhoea caused by -lactamase producing organisms or organisms moderately sensitive to penicillin. Dosage and Administration The usual dose is 400 mg twice daily (morning and evening) by mouth in most infections. Dosage should be adjusted for adults with hepatic insufficiency. Patients should take the drug with meals to avoid gastrointestinal disturbances. Contraindication Pefloxacin is contraindicated in patients who have shown hypersensitivity to Pefloxacin or other quinolones. Pefloxacin is also contraindicated in children and growing adolescents except where the benefits of treatment exceed the risks, in pregnant women, nursing mothers and in patients with glucose-6-phosphate dehydrogenase deficiency. Side Effects Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia, abdominal pain. Disturbance of the central nervous system (CNS) e.g. dizziness, headache, tiredness, confusion, convulsions. Hypersensitivity reactions e.g. skin rashes, pruritus. The other reactions have also been reported are joint pain, mild photosensitivity and thrombocytopenia (at doses of 1600 mg daily). Drug Interactions Antacids may interfere with absorption of Pefloxacin resulting in serum and urine levels lower than desired, so concurrent administration of these agents with Pefloxacin should be avoided.

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Precautions Avoid exposure to sunlight and ultraviolet radiation during treatment with Pefloxacin because of the risk of photosensitivity reactions. Dosage readjustment is required in severe hepatic insufficiency. Commercial Pack Isofloxin Tablet : Box containing 5 aluminium strips of 10 film coated tablets. Each tablet contains Pefloxacin Mesilate BP equivalent to Pefloxacin 400 mg.

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Keolax
Tablet

Description Keolax contains Clobazam, an active ingredient which is a benzodiazepine derivative with actions and uses similar to those of Diazepam. Each tablet contains Clobazam BP 10 mg. Indications Keolax is indicated for the relief of acute or chronic anxiety, tension and agitation. Physical symptoms associated with an underlying anxiety state, phobias and psychosomatic disorders may all respond to treatment with Clobazam. Keolax may be used together with antidepressants in the treatment of anxiety associated with depression. Keolax has also been shown to have a beneficial effect in the treatment of sleep disturbances associated with anxiety and may be used as adjunctive therapy in epilepsy. Dosage and Administration The usual anxiolytic dose for adult is 20-30 mg daily in divided doses or as a single dose given at night. Doses of up to 60 mg daily have been used in the treatment of adult in patients with severe anxiety. Elderly : Doses of 20 mg daily may be used in the elderly patients with anxiety. Children : In children aged 3 years or over, doses should not exceed half the recommended adult dose. There is insufficient experience of the use of Clobazam under three years of age to enable any doses recommendation to be made. Contraindication Clobazam should not be used in patients known to be hypersensitive to benzodiazepines. Precautions Clobazam is a benzodiazepine derivative and in common with other members of this group, may potentiate the effect of central nervous

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system depressant drugs such as alcohol, analgesics, hypnotic and neuroleptics. Addition of Clobazam to anticonvulsant medication may cause a change in plasma levels of these drugs. The ability to drive or operate machinery may be impaired in individuals who are particularly sensitive to the effects of Clobazam or in patients taking high doses of the drug. Clobazam should be used in reduced doses in patients with impaired renal or hepatic function. Use in Pregnancy and Lactation There is a little information on the use of Clobazam in early pregnancy but no untoward effects have been found in animal studies. However, there are reports of a possible malformations in infants due to the administration of other benzodiazepines in early pregnancy. Clobazam has been detected in the breast milk of nursing mothers, but the effect on the neonate is not known. Overdosage Muscle weakness, ataxia, drowsiness and sedation may occur after ingestion of very high doses, the patient may lose consciousness. The treatment of overdosage is symptomatic, stomach should be emptied as soon as possible by gastric lavage and general supportive measures should be undertaken as necessary. Side Effects Keolax is generally well tolerated. Side effects such as drowsiness or dryness of mouth have been reported. These are more likely to occur at the beginning of treatment or a reduction in dose. Pharmaceutical Precaution Keolax should be stored in a cool and dry place. Commercial Pack Keolax Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each tablet contains Clobazam BP 10 mg.

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Lactameal
Tablet/Suspension

Description Lactameal is an antacid containing a combination of Aluminium Hydroxide Gel USP and Magnesium Hydroxide BP. Indications Hyperacidity, gastric and duodenal ulcer, gastritis. Dosage and Administration 2 Lactameal tablets or 2 teaspoonful of Lactameal suspension one hour after meals and at bed time or as directed by the physician. Commercial Pack Lactameal Tablet : Box containing 20 blister strips of 10 tablets, each tablet contains 250 mg Dried Aluminium Hydroxide Gel USP and 400 mg Magnesium Hydroxide BP. Lactameal Suspension : 200 ml suspension in glass bottle, each 5 ml contains Aluminium Hydroxide Gel USP equivalent to 175 mg Aluminium Oxide and 225 mg Magnesium Hydroxide BP.

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Larnox LA
Tablet

Description Larnox LA (Aminophylline) is a stable mixture or combination of Theophylline and Ethylenediamine. Ethylenediamine confers greater solubility in water. Indications It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure. Dosage and Administration Larnox LA tablet possess a slow release mechanism, in which Aminophylline is released to give an effective therapeutic blood levels, lasting up to 12 hours. The recommended initial dose is 1 tablet (350 mg Aminophylline) every 12 hours. The dosage may be gradually increased to a maximum of 2 tablets (700 mg Aminophylline) twice a day depending on the patients response. Note: Tablets should be swallowed whole and not chewed because of the structure of the tablet. Contraindication Aminophylline should not be administered to patients with hypersensitivity to xanthines or ethylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions. Side Effects The most common adverse effects are gastric irritation, nausea, vomiting, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear. Adverse reactions include: Gastrointestinal- nausea, vomiting, epigastric pain, haematemesis, diarrhoea, anorexia, intestinal 216

bleeding and reactivation of peptic ulcer. Central Nervous System- headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability. Cardiovascular- palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing. Renalalbuminuria, diuresis and haematuria. Others- hyperglycaemia, tachypnoea and inappropriate ADH syndrome. Precautions Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given with caution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, neonates and the elderly. Use in Pregnancy and Lactation Theophylline crosses the placental barrier and also passes freely into breast milk, where concentrations are similar to plasma levels. Safe use in pregnancy has not been established. Therefore, use of Aminophylline in pregnant women should be balanced against the risk. Drug Interactions -blockers (e.g., Propranolol) may oppose the effects of Aminophylline. barbiturates, Phenytoin and smoking may decrease Theophylline levels in blood or circulation. Overdosage Toxic effects of overdosage are frequent vomiting, anorexia, unusual thirst, maniacal agitation leading in the most severe cases to convulsions, shock and death. After Aminophylline overdosage by mouth the stomach may be emptied by lavage if within 2 hours of the overdose. Elimination may be enhanced by repeated oral doses of activated charcoal regardless of the route of Theophylline overdose. An osmotic laxative may also be considered, especially if modified-release preparations have been taken. Treatment should be symptomatic and supportive. Serum Theophylline concentrations should be monitored, and if modified release preparations have been taken monitoring should be prolonged.

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Pharmaceutical Precaution Store at 25o C. Keep in a cool and dry place, away from direct sunlight. Keep out of the reach of children. Commercial Pack Larnox LA Tablet : Box containing 50 tablets in 5 x10s blister strips; each tablet contains Aminophylline BP 350 mg.

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Lucidol
Capsule

Description Lucidol (Tramadol Hydrochloride) is a centrally acting analgesic. Tramadol is a synthetic analog of codeine. However, Tramadol has a lower affinity for opioid receptor than codeine. It is less potential for abuse or respiratory depression than other opiate agonist, but both may occur. Indications Lucidol is indicated for the management of moderate to severe pain. Dosages and Administration For the treatment of painful conditions, Lucidol 50 mg to 100 mg can be administered as needed for relief every four to six hours, not to exceed 400 mg per day. For moderate pain, Lucidol 50 mg may be adequate as the initial dose, and for more severe pain, Lucidol 100 mg is usually more effective as the initial dose. Contraindication Lucidol should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product, or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotic, centrally acting analgesics, opioids or psychotropic drugs. Side Effects Most common side effects (Incidence 1% to less than 5% in clinical trails) are malaise, vasodilatation, anxiety, confusion, coordination disturbance, euphoria, nervousness, sleep disorder, abdominal pain, anorexia, flatulence, hypertonia, skin rash, visual disturbance, urinary retention, urinary frequency, and menopausal symptoms. Other infrequently reported side effects are abnormal ECG, hypertension, myocardial ischaemia, palpitations, migraine, gastrointestinal bleeding etc.

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Precautions Lucidol should be administered cautiously in patients at risk for respiratory depression. When large doses of Lucidol are administered with anesthetic medications or alcohol, respiratory depression may result. Lucidol should be used with caution in patients with increased intracranial pressure or head injury. Pupillary changes (miosis) from Tramadol may obscure the existence, extent, or course of intracranial pathology. Lucidol is not recommended for patients who are dependent on opioids. Patients who have recently taken substantial amounts of opioids may experience withdrawal symptoms. Impaired renal function results in a decreased rate and extent of excretion of Tramadol and its active metabolite. In patients with creatinine clearances of less than 30 ml/min, dosing reduction is recommended Overdosage Serious potential consequences of overdosage are respiratory depression and seizure. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. Haemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period. Use in Pregnancy and Lactation Tramadol should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Tramadol is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Paediatric Use The paediatric use of Tramadol is not recommended because safety and efficacy in patients under 16 years age have not been established.

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Commercial Pack Lucidol Capsule : Box containing 3 x 10s capsules in blister strips. Each capsule contains Tramadol Hydrochloride BP 50 mg.

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Megadox
Capsule

Description Megadox contains Doxycycline Hydrochloride BP. Doxycycline Hydrochloride is a semisynthetic tetracycline antibiotic with broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against Staphylococcus aureus and Nocardia. The drug is often active against penicillin-resistant strains of Staphylococcus aureus and against strains of those organisms that are resistant to other Tetracyclines. Certain gram-negative strains of E. coli, Proteus mirabilis and Klebsiella, which are often resistant to Tetracycline, may be sensitive to Doxycycline. In addition, 70-90% of the various anaerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines. Doxycycline is active against most strains of Haemophilus influenzae and is particularly useful for infections with H. ducreyi, Actinomyces, Brucella and Vibrio cholerae. It is also active against Nocardia, Chlamydia, Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema pertenue. It is also active against Plasmodium falciparum. Indications Megadox is indicated in the following infections caused by susceptible microorganisms:

Pneumonia and other respiratory tract infections caused by Klebsiella, Pneumococci and Mycoplasma pneumoniae Gastrointestinal infections Genitourinary tract infections Soft tissue infections Ophthalmic infections (trachoma) caused by Chlamydia trachomatis Acne

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Prophylaxis of Plasmodium falciparum malaria Miscellaneous group of infections : Prostatitis, Psittacosis, Trigonitis, Louse borne typhus, Plague etc.

Dosage and Administration Adults : Usual dose is 200 mg on first day, then 100 mg daily for 7-10 days. Severe infections (including refractory urinary tract infections) 200 mg daily for 10 days. Acne : 100 mg daily. Uncomplicated genital chlamydia, non-gonococcal urethritis : 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease). Contraindication Doxycycline Hydrochloride is contraindicated in pregnancy, nursing mother, children under 12 years of age and in patients with known hypersensitivity to any of the Tetracyclines. Side Effects Since Megadox is virtually completely absorbed, side effects of the lower bowel particularly diarrhoea have been infrequent. Gastrointestinal effects e.g., anorexia, nausea, diarrhoea, vomiting, glossitis, dysphagia, enterocolitis and anogenital inflammatory lesions have been reported occasionally. Hypersensitivity reactions e.g., urticaria, angioneurotic oedema, anaphylactic purpura, pericarditis and exacerbation of systemic lupus erythematosus may occur. Haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have also been reported. On rare occasions, anaphylaxis may occur. In case of overdose, discontinue medication, treat symptomatically and institute supportive measures. Pharmaceutical Precaution Store in a cool and dry place. Keep out of the reach of children. High Risk Groups Neonates and children : Tetracycline may cause permanent discoloration of the teeth and so is contraindicated for neonates and children under 12 years. Nursing Mother : Tetracyclines enter breast milk, and mothers taking these drugs should not breastfeed their child.

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Pregnant women : Tetracycline should be avoided in pregnant women, because of the risk of both staining and effect on bone growth in the foetus. Elderly : No special precautions are necessary in the elderly. Commercial Pack Megadox Capsule : Box containing 10 blister strips of 10 capsules, each capsule contains Doxycycline Hydrochloride BP equivalent to 100 mg Doxycycline.

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MegatrimDS
Tablet

Megatrim
Suspension

Description Megatrim is a broad spectrum antibacterial drug containing Trimethoprim BP and Sulfamethoxazole BP in a 1:5 fixed combination. Each Megatrim DS tablet contains 160 mg Trimethoprim BP and 800 mg Sulfamethoxazole BP. Each 5 ml of Megatrim Suspension contains 40 mg Trimethoprim BP and 200 mg Sulfamethoxazole BP. Indications Megatrim is bactericidal in vitro to a wide range of Gram-positive and Gram-negative organisms, including Streptococcus, Staphylococcus, Pneumococcus, Neisseria, B. catarrhalis, Escherichia coli, Klebsiella, Proteus spp., Haemophilus, Salmonella, Shigella, Vibrio cholerae, Brucella, Pneumocystis carinii, Nocardia and Bordetella. A particularly high degree of activity is exhibited against Haemophilus influenzae, E. coli and Proteus spp., making Megatrim particularly suitable for the treatment of chronic bronchitis and urinary tract infections. Megatrim exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganisms. The synergy thus produced accounts for the high degree of bactericidal activity. Indications Respiratory tract infections, including acute and chronic bronchitis (treatment and prophylaxis), bronchiectasis, lung abscess, lobar and broncho-pneumonia, Pneumocystis carinii pneumonitis, sinusitis and otitis media.

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Genito-urinary tract infections, including urethritis, acute and chronic cystitis, pyelonephritis, prostatitis and gonorrhoea. Gastro-intestinal tract infections, caused by Salmonella typhi and Salmonella paratyphi, including the chronic carrier state. Other infections, caused by a wide range of organisms confirmed to be susceptible to Megatrim and where the therapeutic benefits are considered to outweigh the possible occurrence of adverse events. Such infections include acute and chronic osteomyelitis, acute brucellosis, skin infections including pyoderma, abscesses and wound infections, septicaemia, bacillary dysentery and cholera (as an adjuvant to fluid and electrolyte replacement), nocardiosis and mycetoma. Dosage and Administration Dosage Guideline Megatrim-DS tablet :
Adults and children over 12 years Usual dosage High dosage for severe infections and septicaemia Uncomplicated gonorrhoea Minimum dosage for longterm treatment (>14 days) One Megatrim-DS tablet twice daily 1 Megatrim-DS tablets, twice daily 2 Megatrim-DS tablets 12 hourly for 2 days or 2 Megatrim DS tablets with 8-12 hours intervals between the doses Megatrim-DS tablet twice daily

Megatrim Suspension
Children 6-12 years 2-5 years up to 2 years 1-2 teaspoonful twice daily -1 teaspoonful twice daily teaspoonful twice daily

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Duration of therapy : In acute infections, apart from gonorrhoea, Megatrim DS should be given for at least 5 days or until the patient has been symptom-free for 2 days. Treatment for prostatitis and acute brucellosis should be maintained for a period of at least 4 weeks, whilst in nocardiosis and mycetoma, dosage guideline requires long-term therapy. Contraindication - Hypersensitivity to Trimethoprim or Sulphonamides. - Patients with documented megaloblastic anaemia due to folate deficiency. - Patients showing marked liver parenchymal damage, blood dyscrasia, severe renal insufficiency, glucose 6-phosphate dehydrogenase deficiency. - Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus. Side Effects The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulfamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment. Precautions Prolonged full dose treatment with Sulfamethoxazole-Trimethoprim combination is associated with the risk of macrocytic anaemia due to the drugs interference in the conversion of folic acid into folinic acid. If this occurs, it can be reversed by giving folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.

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Commercial Pack Megatrim-DS Tablet : Box containing 10 blister strips of 10 tablets. Each Megatrim DS tablet contains 160 mg Trimethoprim BP and 800 mg Sulfamethoxazole BP. Megatrim Suspension : 60 ml suspension in amber glass bottle. Each 5 ml of Suspension contains 40 mg Trimethoprim BP and 200 mg Sulfamethoxazole BP.

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Melphin
Tablet/Suspension

Description Melphin contains Pyrantel Pamoate USP. It is an anthelmintic effective against Ascaris lumbricoides (roundworm). Enterobius vermicularis (pinworm), Ancylostoma duodenale/Necator americanus (hookworm) and Trichostrongylus. Indications Melphin is specifically indicated for the treatment of infestations caused by Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale/Necator americanus and Trichostrongylus. Melphin may be used for the treatment of infestations with one or more of these parasites in both adults and children. Dosage and Administration Melphin is given orally at anytime without regard to ingestion of food or beverages. A single dose of 11 mg/kg body weight, to a maximum of 1 g, should be given to treat infestations caused by the parasites mentioned above. In the case of Pinworm, it is often wise to repeat the dose after an interval of 2 weeks. Contraindication Since Pyrantel Pamoate has not been studied in pregnant women, use of Melphin in such patients is normally contraindicated. Melphin is not recommended for children below 1 year of age. Side Effects Melphin is well tolerated in recommended dosage. When given in large dosage, Melphin may cause gastrointestinal upset such as anorexia, nausea, vomiting and diarrhoea. Other side effects that may occur in rare occasions are headache, dizziness and rash. Precautions Since Pyrantel Pamoate and Piperazine appear to be mutually antagonistic, Melphin should not be given together with Piperazine. Melphin should be kept out of the reach of children.

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Commercial Pack Melphin Tablets : Box containing 100 tablets in 10 x 10s aluminium strips, each tablet contains Pyrantel Pamoate USP equivalent to 125 mg Pyrantel. Melphin Suspension : 10 ml suspension in amber glass bottle, each ml contains Pyrantel Pamoate USP equivalent to 50 mg Pyrantel.

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Modipran
Capsule

Description Modipran is a preparation of Fluoxetine Hydrochloride BP containing 20 mg of Fluoxetine per hard gelatin capsule. Fluoxetine Hydrochloride is a selective inhibitor of serotonin reuptake in presynaptic neurons and is used as an antidepressant with very long half life. Indications Modipran (Fluoxetine Hydrochloride) is indicated for the treatment of depressive illness, bulimia nervosa and obsessive compulsive disorder. Dosage and Administration Initial treatment : Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to obtain satisfactory antidepressant response. Consequently, a dose of 20 mg/day administered in the morning is recommended as the initial dose. A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment. A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day. Maintenance Treatment : It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. 231

Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa. Contraindication Modipran (Fluoxetine Hydrochloride) is contraindicated in patients known to be hypersensitive to it. Monoamine Oxidase Inhibitors : There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued fluoxetine and are then started on an MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Modipran should not be used in combination with a MAOI, or within 14 days of discontinuing therapy with an MAOI. Since fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine and before starting an MAOI. Warning A small percentage (4%) of patients have been found to develop rash and/or urticaria associated with fever, leukocytosis, arthralgia, oedema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria and mild transaminase elevation. Most patients improved promptly with discontinuation of the drug and/or adjunctive treatment with antihistamines or steroids. There were also rare cases of serious cutaneous systemic illness and serum sickness. Other events include bronchospasm, angioedema, fibrosis, vasculitis with rash, and involvement of lung, kidney and liver. Use in Pregnancy and Lactation In animal studies, no teratogenicity or harmful effect was found. Because animal reproductive studies are not always predictive of human responses, fluoxetine should be used in pregnancy only if clearly needed.

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As Fluoxetine is excreted in human milk, caution should be exercised when Fluoxetine is administered to nursing women. Precautions As Fluoxetine undergoes hepatic metabolism and renal excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycaemic control and therefore caution is also warranted in diabetic subjects. Depressed patients with suicidal tendencies should be carefully supervised during treatment. Fluoxetine is not usually considered a suitable form of therapy for the depressive component of bipolar (manic depressive) illness as mania may be precipitated. Use in Children: Safety and effectiveness in children have not been established. Side Effects Gastrointestinal : Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea. Neurological : Anxiety, nervousness, insomnia/drowsiness and fatigue. Others : Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that fluoxetine therapy should be discontinued in any patient who develops a skin rash. Overdosage In overdosage nausea, vomiting and excitation of the central nervous system are considered to be prominent features; death has been reported. Treatment involves emesis induction or gastric lavage followed by symptomatic and supportive therapy. Forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit. Commercial Pack Modipran Capsule : Box containing 10 aluminium strips of 10 capsules. Each capsule contains Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20 mg. 233

Momento
Tablet/Syrup

Description Momento (Desloratadine) is a potent, rapidly effective, long-acting, nonsedative antihistamine with selective H receptor histamine antagonist 1 activity. It is an orally administered drug. Each film-coated Momento tablet contains Desloratadine INN 5 mg. Each 5 ml Syrup contains Desloratadine INN 2.5 mg. Indications Allergic Rhinitis : Momento is indicated for the relief of the nasal and non-nasal symptoms of allergic rhinitis (Both seasonal and perennial) in patients 12 years of age and older. Chronic Idiopathic Urticaria : Momento is also indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older. Dosage and Administration Adult and Children over 12 years : One 5 mg tablet or 2 teaspoonful once daily Child 6-11 years : tablet or 1 teaspoonful once daily Child 2-5 years : teaspoonful daily In patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Adverse Effects In general it is well tolerated. Clinical trials suggest a very low rate of adverse effects associated with Desloratadine administration. Among the very few adverse effects commonly reported by small percentage of 234

patients are dry mouth, fatigue, myalgia, and somnolence. Less common side effects may include headache, nausea, dizziness, dyspepsia, pharyngitis etc. Contraindication Momento is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. Precautions Pregnancy Category C : Desloratadine was not teratogenic in rats or rabbits at doses higher enough to produce an AUC, which is 210-230 times the AUC in human at the recommended daily oral dose. There are, however, no adequate and well-controlled studies of Desloratadine in pregnant women. Because animal reproduction studies are not always predictive of human response, Desloratadine should be used during pregnancy only if clearly needed. Nursing Mothers : Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Momento, taking into account the importance of the drug to the mother. Paediatric Use : The safety and effectiveness of Desloratadine in pediatric patients under 12 years of age have not been established. Geriatric Use : In general, dose selection for an elderly patient should be cautious, taking into account of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Drug Interaction Concomitant administration of Erythromycin, Ketoconazole, Azithromycin, Fluoxetine, and Cimetidine with Desloratadine increased the plasma concentration of Desloratadine. But there were no clinically relevant changes in the safety profile of Desloratadine. Overdosage No clinically relevant adverse events were reported. In the event of overdose, consider standard measures to remove any unabsorbed drug.

235

Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by haemodialysis. Pharmaceutical Precaution Store at a temperature between 2 C and 25C. It is heat sensitive, so avoid exposure at or above 30C. Commercial Pack Momento Tablet : Each box contains 10 blister strips of 10 tablets. Each tablet contains Desloratadine INN 5 mg. Momento Syrup : 60 ml syrup in amber glass bottle, each 5 ml contains Desloratadine INN 2.5 mg.

236

Monate
Tablet

Description Isosorbide Mononitrate is an organic nitrate. It is a vasodilator, active on both arteries and veins. Each tablet contains Isosorbide Mononitrate BP 20 mg. Dosage and Administration Adults : The recommended dosage is from 20 to 120 mg daily in divided doses. The majority of patients will require a dosage in the range of 40 to 60 mg daily in divided doses. The tablets should be taken with fluid and swallowed whole without chewing. Elderly : There is no evidence to suggest an adjustment of dose. However, caution may be required in elderly patients who are known to be susceptible to the effects of hypotensive medication. Children : The safety and efficacy of Isosorbide Mononitrate in children has not been established. Indications Monate tablets are indicated for prophylaxis of angina pectoris and as an adjunct to treatment of heart failure. Contraindication Isosorbide Mononitrate is contraindicated in patients with a known hypersensitivity to Isosorbide Mononitrate or Isosorbide Dinitrate. It is also contraindicated in cases of marked low blood pressure, shock and acute myocardial infarction with low left ventricular filling pressure. Adverse Reactions A number of nitrate-related adverse effects may occur during treatment including headache and feelings of dizziness. The incidence of such effects is normally highest at the commencement of treatment and tends to decline with time. In highly sensitive patients hypertension may occur, especially after a high dose. Other reactions, including feelings of 237

weakness, nausea or vomiting may occur occasionally. Side effects that have been associated with Isosorbide Dinitrate (e.g. flushing, postural hypotension, dry rash, exfoliative dermatitis) may also occur. Precautions Isosorbide Mononitrate tablet is not indicated for the relief of an acute attack when sublingual or buccal Glyceryl Trinitrate tablets or spray should be used. In the case of acute myocardial infarction, Isosorbide Mononitrate tablets should be continued only under strict medical supervision. Since a rebound phenomenon cannot be excluded, therapy with Isosorbide Mononitrate should be terminated gradually rather than stopping abruptly. Use in Pregnancy and Lactation No data have been reported which would indicate the possibility of adverse effects resulting from the use of organic nitrates in pregnancy. However, safety in pregnancy has not been established. There is no information on excretion of Isosorbide Mononitrate in breast milk. Use in pregnancy and lactation is not recommended unless considered essential by the physician. Drug Interactions Orthostatic hypotension may occur with combined use of calcium channel blockers, antihypertensive agents, phenothiazines or tricyclic antidepressants. Use of alcohol with Isosorbide Mononitrate may produce severe hypotension and collapse. Pharmaceutical Precaution Store at a temperature between 15o and 30o C. Commercial Pack Monate Tablet : Box containing 100 tablets in 10 x 10s blister strips. Each tablet contains Isosorbide Mononitrate BP 20 mg.

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Monocast
Tablet

Description The active ingredient of Monocast tablet is Montelukast Sodium INN. Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Each Monocast 10 film coated tablet contains Montelukast Sodium INN equivalent to 10 mg Montelukast. Each Monocast 5 chewable tablet contains Montelukast Sodium INN equivalent to 5 mg Montelukast. Each Monocast 4 chewable tablet contains Montelukast Sodium INN equivalent to 4 mg Montelukast. Mechanism of Action The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotrienemediated effects include airway oedema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early and late-phase reactions and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction. Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or -adrenergic receptors). Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.

239

Indications Monocast is indicated for the prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older. Monocast is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and paediatric patients 2 years of age and older. Dosage and Administration General Information : Monocast should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patients needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening. Adults and Adolescents 15 years of age and older with asthma or seasonal allergic rhinitis : The dosage is one 10 mg tablet daily. Paediatric patients 6 to 14 years of age with asthma or seasonal allergic rhinitis : The dosage is one 5 mg chewable tablet daily. No dosage adjustment within this age group is necessary. Paediatric patients 2 to 5 years of age with asthma or seasonal allergic rhinitis : The dosage is one 4 mg chewable tablet daily. Paediatric patients 12 to 23 months of age with asthma : The dosage is one 4 mg chewable tablet daily to be taken in the evening. Safety and effectiveness in paediatric patients younger than 12 months of age have not been established. Contraindication Hypersensitivity to any component of this product. Side Effects Adolescents and Adults 15 years of age and older : In placebo-controlled clinical trials, Montelukast has been evaluated for safety in approximately 2600 adolescent and adult patients of 15 years and older, the following adverse experiences reported with Montelukast occurred in greater than or equal to 1% of patients. General : Asthenia/fatigue, Fever, Pain;

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Gastrointestinal: Dyspepsia, Gastroenteritis; Nervous System/Psychiatric : Dizziness, Headache; Respiratory System: Congestion, Cough, Influenza; Skin: Rash; Laboratory adverse experiences : ALT increase, AST increase, Pyuria. Paediatric patients 6 to 14 years of age : In paediatric patients receiving montelukast, the following events occurred with a frequency 2% are diarrhoea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viral infection. With prolonged treatment, the adverse profile did not change significantly. Precautions General : Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued during acute exacerbation of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbation of asthma after exercise should continue to use their usual regimen of inhaled -agonist as prophylaxis and have available for rescue a short-acting inhaled -agonist. Patients with known Aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Although montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other nonsteroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients. Eosinophilic Conditions : In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians

241

should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between montelukast and these underlying conditions has not been established. Paediatric Use Safety and efficacy of Montelukast has been established in adequate and well-controlled studies in paediatric patients with asthma and allergic rhinitis between age 1 to 14 years. Long-term trials evaluating the effect of chronic administration of Montelukast on linear growth in paediatric patients have not been conducted. Geriatric Use Of the total number of subjects in clinical studies of Montelukast, 3.5% were 65 years of age and over and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. But greater sensitivity of some older individuals cannot be ruled out. Use in Pregnancy and Lactation Montelukast crosses the placenta following oral dosing in rats and rabbits. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Montelukast should be used during pregnancy only if clearly needed. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother. Drug Interactions Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug-interaction studies, the recommended clinical dose of montelukast did not have clinically

242

important effects on the pharmacokinetics of the following drugs: Theophylline, Prednisolone, oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35 g), Terfenadine, Digoxin, and Warfarin. Although additional specific interaction studies were not performed, Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without clinically evident adverse interactions. These medications included thyroid hormones, sedative hypnotic, non-steroidal anti-inflammatory agents, benzodiazepines, and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10 mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast. Overdosage There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed were thirst, somnolence, hyperkinesia, and abdominal pain. It is not known whether Montelukast is removed by peritoneal dialysis or haemodialysis. Commercial Pack Monocast 10 Tablet : Box containing 1 blister strip of 10 film coated tablets. Each tablet contains Montelukast Sodium INN equivalent to 10 mg Montelukast. Monocast 5 Tablet : Box containing 2 blister strips of 20 chewable tablets. Each tablet contains Montelukast Sodium INN equivalent to 5 mg Montelukast. Monocast 4 Tablet : Box containing 2 blister strips of 20 chewable tablets. Each tablet contains Montelukast Sodium INN equivalent to 4 mg Montelukast.

243

Napa
Tablet/Syrup/Drops/Suppository

Description Napa (Paracetamol) is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics. Indications All conditions requiring relief from pain and fever such as neuritis, neuralgia, headache, earache, toothache, pain due to rheumatic disorder, cold, influenza, dysmenorrhoea, post-vaccination pain and fever of children etc. Napa suppositories are used for rapid symptomatic management of pain and fever. It is given as rectal suppository for mild to moderate pain and for pyrexia. Dosage and Administrations Tablets : Adults- 1-2 tablets 3-4 times daily; Syrup : Adults- 4-8 measuring spoonful 3-4 times daily; Children- 6-12 years- 2-4 measuring spoonful 34 times daily, 1-5 years- 1-2 measuring spoonful 3-4 times daily. Up to 1 year- -1 measuring spoonful 3-4 times daily. Paediatric drops : Neonates and children- 0-3 months- 0-5 ml, 4-11 months- 1 ml, 12-23 months- 1.5 ml, 2-3 years- 2 ml 4-5 years- 3 ml four times daily or as directed by physicians. Suppositories : Children- 1-5 years- 125-250 mg, 6-12 years- 250500 mg, up to 4 times daily. Contraindication Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Precautions Paracetamol should be given with care to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver. Side Effects Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, 244

neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally. Overdosage Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Commercial Pack Napa Tablet : Box containing 50 blister strips of 10 tablets, each contains 500 mg Paracetamol BP. Napa Syrup : Bottle containing 60 ml syrup, each 5 ml contains 120 mg Paracetamol BP. Napa Paediatric Drops : Bottle containing 15 ml drops, each ml contains 80 mg Paracetamol BP. Napa 125 Suppository : Box containing 4 foils of 5 suppositories (4 x 5s), each containing 125 mg Paracetamol BP. Napa 250 Suppository : Box containing 4 foils of 5 suppositories (4 x 5s), each contains 250 mg Paracetamol BP.

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Nazolin
Nasal Spray

Description Oxymetazoline Hydrochloride, the active ingredient of Nazolin nasal spray, is a sympathomimetic amine of the imidazoline class. The chemical name of the active ingredient is 3-[(4,5-Dihydro-1 H-imidazole-2yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol hydrochloride. Indications As a nasal decongestant in allergic rhinitis, with or without the addition of topical antihistamines or sodium cromoglycate. As a nasal decongestant in sinusitis where there is evidence of obstruction of osteal opening to the sinuses. As nasal decongestant in otitis media where there is evidence of obstruction of eustachian tube, especially in subacute serous otitis media ('glue ear') and otitic barotrauma. As a decongestant in an infective rhinitis(e.g. an acute viral upper respiratory tract infection). Where there is a secondary bacterial infection, there is no evidence of benefit. Dosage and Administration For nasal use, 2-3 sprays should be instilled into each nostril twice daily. The nasal spray can be used with the patient in the upright position. Sprays are generally unsuitable for young children because of the small size of their nostril. A treatment course should not normally exceed three to five days, and on no account should it be continued for longer than two weeks because of the risk of developing rhinitis medicamentosa'. Contraindication As a sympathomimetic, oxymetazoline should not be used in patients being simultaneously treated with monoamine oxidase inhibitor therapy. Narrow-angle glaucoma. The safety of use in pregnancy has not fully been established and administration of oxymetazoline during that time should be avoided unless absolutely essential. 246

Precautions The drug should be used with caution in patients suffering from Coronary artery disease, Hypertension, Hyperthyroidism and Diabetes mellitus. Side Effects Used correctly (as an intranasal application), the local vasoconstriction produced by the drug inhibits the absorption and a systemic action is unlikely. If, however, some of the drops are swallowed, they can be absorbed from the gastrointestinal tract and a systemic effect can be produced. In children an overdose, if swallowed and absorbed, has been reported to cause sedation. As oxymetazoline is an 2 adrenergic agonist, it might be expected to produce effects similar to those of clonidine, with a short-lived rise in pressure caused by a peripheral action, followed by more prolonged hypotension and sedation as a result of inhibition of sympathetic outflow from brain. Overuse is associated with a more persistent rhinitis related to the rebound phenomenon- the condition known as rhinitis medicamentosa. It is claimed that, because of its more prolonged action, oxymetazoline is less likely to cause rebound congestion than other decongestants. Stinging, discomfort or a dryness locally in the nose or eye is encountered infrequently. If the symptoms persist, the discomfort from the use of the drops probably outweighs any advantage they may confer. Headache has been reported, albeit infrequently, as has tachycardia. Pharmaceutical Precaution Nazolin nasal spray should be stored at a temperature below 30o C. Protect from frost and direct sunlight. Commercial Pack Nazolin Nasal Spray : Each bottle contains 200 metered doses of 0.05% aqueous nasal preparation of Oxymetazoline Hydrochloride USP in a total volume of 10 ml. Each actuation delivers 0.05 ml containing 25 g of Oxymetazoline Hydrochloride.

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Nebactil
Suspension

Description Nebactil contains Nalidixic Acid BP. Nebactil is available in suspension form. Each 5 ml suspension contains 300 mg of Nalidixic Acid BP. It is a bactericidal DNA gyrase inhibitor. Indications Nalidixic Acid is indicated inw Urinary tract infections caused by susceptible Gram-negative microorganisms, including the majority of Proteus strains, Klebsiella, Enterobacter spp. and E. coli. w Gastrointestinal infections caused by Salmonella and Shigella. Dosage and Administration Adult : Initial therapy : 1 g 4 times/day (Total dose 4 g/day) for 1 or 2 weeks. Prolonged therapy : May be reduced to 2 g/day after the initial treatment period. Children : 3 months to 12 years of age: Initial therapy : 55 mg/kg/day in 4 equally divided doses. Prolonged therapy : May be reduced to 33 mg/kg/day Contraindication Nebactil is contraindicated to known hypersensitivity to Nalidixic Acid, history of convulsive disorders and patients with porphyria. Relative Contraindication Should be used with caution in patients with liver and renal disease. Also in glucose 6-phosphate dehydrogenase deficiency. Side Effects Central Nervous System : Drowsiness, weakness, headache, dizziness, vertigo, toxic psychosis, brief convulsion (rare). Ophthalmic : Reversible subjective visual disturbances occur infrequently (generally with each dose during the first few days) and over brightness of lights, change in colour

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perception, focusing difficulty, decrease in visual acuity and double vision. Gastrointestinal : Abdominal pain, nausea, vomiting, diarrhoea. Hypersensitivity : Rash, pruritus, urticaria, angioedema, arthralgia with joint stiffness and swelling, anaphylactoid reaction (rare). Haematologic : Thrombocytopenia, leucopenia or haemolytic anaemia, sometimes associated with glucose 6-phosphate dehydrogenase deficiency (rare). Miscellaneous : Cholestatic jaundice, cholestasis, paraesthesia, metabolic acidosis (rare), photosensitivity reactions (eg. erythema and painful bullae on exposed skin surfaces). Precautions General : Should be used with caution in liver disease, epilepsy or severe cerebral arteriosclerosis patients. Periodic blood counts and renal and liver function test should be performed if treatment is continued for >2 weeks. If bacterial resistance emerges, rapid change of drug should be made. Children : Should not be used to infants <3 months of age. Use in Pregnancy and Lactation Nalidixic Acid is DNA-gyrase inhibitor which is capable of causing DNA damage, and there is possibility that it may cause cartilage damage. Thus, it is best to avoid using in pregnancy. Commercial Pack Nebactil Suspension : Bottle contains 50 ml of oral suspension. Each 5 ml contains 300 mg of Nalidixic Acid BP.

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Neo Kit

Description Helicobacter pylori is implicated in the etiology of gastritis and peptic ulceration in humans. It is found in 90% cases of duodenal ulcer, 90% cases of chronic antral gastritis and 70% cases of gastric ulcer. Conventional H2 receptor antagonists do not suppress or eradicate H. pylori and has a high rate of ulcer recurrence. The standard triple therapy regimens have proved to be effective for eradicating H. pylori. Each Neo Kit containsClarithromycin Omeprazole Metronidazole

USP BP BP

500 mg : 20 mg : 400 mg :

1 Tablet 1 Capsule 1 Tablet

Indications Neo Kit is indicated in the eradication of H. pylori in active chronic gastritis, duodenal and gastric ulcers. Dosage and Administration One Neo Kit (2 tablets and 1 capsule in one blister strip) twice daily (12 hourly) for 7 days. Contraindication Neo Kit is contraindicated in patients with known hypersensitivity to Clarithromycin, Omeprazole and Metronidazole. Side Effects The drugs of the Neo Kit are well tolerated. Side effects may be that of Clarithromycin, Omeprazole and Metronidazole which include nausea, vomiting, diarrhoea and abdominal pain. Other side effects include unpleasant metallic or bitter taste, headache, drowsiness, vertigo, constipation, abdominal colic and flatulence but are rare.

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Precautions Caution should be exercised in administering Clarithromycin in patients with impaired hepatic and renal functions. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. Proton pump inhibitors should be used in caution in patients with liver disease, during pregnancy and lactation. Metronidazole should not be used in patients with blood dyscrasia. It is suggested that Metronidazole should not be given in the first three months of pregnancy. Use in Pregnancy and Lactation Neo Kit should be used with caution during pregnancy and lactation only if the potential benefit justifies the risk. Use in Children Safety and effectiveness in children have not been established. Drug Interactions Clarithromycin: Concomitant administration with Theophylline has been associated with increased serum Theophylline level. Effects of Digoxin and Warfarin may be potentiated with concomitant administration of Clarithromycin. Omeprazole: Effects of Warfarin enhanced and absorption of Ketoconazole reduced by Omeprazole. Metronidazole: The effect of Warfarin enhanced by Metronidazole. Commercial Pack Neo Kit : Box containing 14 kits. Each kit contains one tablet of Clarithromycin USP 500 mg , one capsule of Omeprazole BP 20 mg and one tablet of Metronidazole BP 400 mg.

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Neocard
Tablet

Description Neocard (Diltiazem Hydrochloride) tablet is available in potencies of 30 mg and 60 mg for oral administration. Indications Neocard is a calcium antagonist. It is indicated for the prophylaxis and treatment of classical and vasospastic angina pectoris and hypertension, myocardial infarction, coronary artery spasm, hypertension, cardiac arrhythmias, Raynauds phenomenon, oesophagal motility disorder, and migraine. Dosage and Administration General: Usual dose is 60 mg three times daily. However patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the divided dose may be increased to 180360 mg/day. Dosage may also be started as 30 mg four times daily and increasing at 1 to 2 days intervals until the optimum response is achieved. Higher doses up to 480 mg/day have been used with benefit in some patients especially in unstable angina. There is no evidence of any decrease in efficacy at these high doses. Neocard has not been reported to precipitate angina. Elderly and patients with impaired hepatic or renal function: The recommended starting dose is 60 mg twice daily. The heart rate should be measured regularly in these groups of patients and the dose should not be increased if the heart rate falls below 50 beats per minute. Children: Not recommended. Contraindication Diltiazem Hydrochloride is contraindicated in pregnant women or those of child bearing potential, patients with sick sinus syndromes, patients with second or third degree AV block, patients with severe bradycardia and patients who demonstrated hypersensitivity to the drug. 252

Precautions Patients with mild bradycardia or a prolonged PR interval should be observed closely. Neocard does not have a significant myocardial depressant effect and is well tolerated in patients with poor left ventricular function. The drug should be used with caution in patients with impaired hepatic or renal function. Drug Interactions Diltiazem Hydrochloride should be carefully administered in case of concomitant use with the following drugs. Anti-hypertensive agents : effects of anti-hypertensive agents are enhanced Propranolol : concentration of propranolol may be increased Carbamazepine : plasma level of Carbamazepine may be increased and it may cause Carbamazepine induced toxic symptoms such as sleepiness, nausea, vomiting, vertigo etc. Digoxin preparations : plasma level of Digoxin is increased Cyclosporin: may increase serum cyclosporin concentration by 75% or more. Side Effects Diltiazem Hydrochloride produces few side effects and these are usually mild. Oedema, nausea, headache, finger swelling, skin rash, dizziness and asthenia have been reported. Other adverse effects include bradycardia, AV block, hypotension, gastrointestinal symptom, hyperactivity with associated psychiatric symptoms and mild elevation of liver function tests. Overdosage Experience of overdosage in man is limited and spontaneous recovery has been seen in reported cases. However, observation in coronary care unit (CCU) is advisable with corrective measures available for possible hypotension and conduction disturbances. Commercial Pack Neocard-30 Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains Diltiazem Hydrochloride USP 30 mg. Neocard-60 Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains Diltiazem Hydrochloride USP 60 mg. 253

NeoceptinR
Tablet/Syrup

Description The active ingredient of Neoceptin R is Ranitidine. Neoceptin R is a histamine H2 receptor antagonist. It inhibits basal and stimulated secretion of gastric acid. Neoceptin R is rapidly absorbed after oral administration. Food or antacid does not interfere its absorption. Indications Neoceptin R is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison Syndrome and in other conditions where reduction of gastric acidity is beneficial. Dosage and Administration Duodenal and Gastric Ulcer : The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks. Reflux Oesophagitis : 150 mg twice daily or 300 mg at bed time for up to 8 weeks. Zollinger-Ellison Syndrome : 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated. Episodic Dyspepsia : 150 mg twice daily or 300 mg at bed time for up to 6 weeks. Maintenance : 150 mg at night for preventing recurrences. Child (peptic ulcer) : 2-4 mg/kg twice daily, maximum 300 mg daily. Side Effects Neoceptin R is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported. 254

Precautions Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function. Use in Pregnancy and Lactation Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Neoceptin R should only be used during pregnancy if considered essential. Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother. Pharmaceutical Precaution Store in a cool and dry place. Protect from light. Commercial Pack Neoceptin R-150 Tablet : Box containing 100 tablets in 10 x 10s Alu-Alu form packs. Each round, bi-convex, film coated tablet contains Ranitidine Hydrochloride USP equivalent to Ranitidine 150 mg. Neoceptin R-300 Tablet : Box containing 100 tablets in 10 x 10s aluminium strips. Each round, bi-convex, film coated tablet contains Ranitidine Hydrochloride USP equivalent to Ranitidine 300 mg. Neoceptin R Syrup : Bottle containing 100 ml sugar free syrup. Each 5 ml contains Ranitidine Hydrochloride USP equivalent to Ranitidine 75 mg.

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Neodrop
Drops

Description Neodrop (Simethicone) is used as an antiflatulent to relieve symptoms commonly referred to gas including upper gastrointestinal bloating, fullness or stuffed feeling. The clinical use of Neodrop is based on its antifoam properties. Its defoaming action relieves flatulence by dispensing and preventing the formation of mucous surrounded gas pockets in the gastrointestinal tract. Neodrop acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Neodrop aids in the elimination of gas from the gastrointestinal tract and can be used to reduce postoperative gas pains. Neodrop can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows. Indications Flatulence, abdominal distention, fullness, gas and windy colic : Neodrop (Simethicone) is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods that disagree. Neodrop is especially acts in the stomach and intestines of infants and child. Thus Neodrop enables freeing and eliminating the gas more easily by belching or passing flatus. Large bowel preparation : Addition of Neodrop to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in patients undergoing colonoscopy. Treatment of poisoning : Neodrop has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents. Dosage and Administration Take after meals and at bedtime. Can be given with infants feeds. Children less than 2 years of age- 20 mg (0.3 ml Neodrop drops) 4 times

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daily up to 240 mg (3.6 ml Neodrop drops)/day. Children: 2-12 years of age- 40 mg (0.6 ml Neodrop drops) 4 times daily. Adults: 40-80 mg (0.6 ml-1.2 ml Neodrop drops) 4 times daily, up to 500 mg (7.5 ml Neodrop drops)/day. Side Effect Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion. Precautions Do not exceed 12 doses per day except under the advice and supervision of a physician. Drug Interaction There is no evidence that simethicone modifies the effect of other drugs. The defoaming effect of simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone. Use in Pregnancy and Lactation No data are available to suggest any harmful effects on pregnant women. Pharmaceutical Precaution Should be stored in well-closed bottle, protected from light, and at a temperature not exceeding 30oC. Keep the medicine out of the reach of children. Commercial Pack Neodrop Paediatric Drops : Bottle containing 15 ml Simethicone drops with a plastic dropper. Each ml drop contains Simethicone USP 67 mg.

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Neofloxin
Tablet

Description Ciprofloxacin, a fluoroquinolone, is an extremely broad spectrum DNA gyrase inhibitor antimicrobial agent. The active ingredient of Neofloxin is Ciprofloxacin Hydrochloride USP. Indications Neofloxin is indicated for the treatment of single infection or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including aminoglycosides, penicillins and cephalosporins. As antibacterial concentrations of Ciprofloxacin are obtained in serum and body tissues as well as in the urine following administration by mouth, Ciprofloxacin has been suggested for use in the treatment of a wide range of infections caused by susceptible organisms including infections of the urinary, respiratory and gastrointestinal tracts, gonorrhoea and septicaemia. The extensive tissue penetration of Neofloxin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Ciprofloxacin to be used alone (pending sensitivity results) or in combination with an aminoglycoside or with beta-lactam antibiotics for instance when severe neutropenia is present or with an antibiotic active against anaerobes where the presence of Bacteroides fragilis is suspected. Neofloxin is indicated for the treatment of the following infections caused by sensitive bacteria : Severe systemic infections : Septicaemia, bacteraemia, peritonitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns. Respiratory tract infections : Lobar and bronchopneumonia, acute, and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyaema. Urinary tract infections : Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis. 258

Skin and soft tissue infections : Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns. Gastro-intestinal infections : Enteric fever, infective diarrhoea. Infection of the biliary tract : Cholangitis, cholecystitis, empyaema of the gall bladder. Intra abdominal infections : Peritonitis, intra-abdominal abscesses. Bone and joint infections : Osteomyelitis, septic arthritis. Pelvic infections : Salpingitis, endometritis, pelvic inflammatory diseases. Eye, ear, nose and throat infections : Otitis media, sinusitis, mastoiditis, tonsillitis. Genito-urinary tract infection : Gonorrhoea (urethral, rectal and pharyngeal) caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin. In vitro studies have shown that the antibacterial action of Ciprofloxacin results from the inhibition of bacterial DNA gyrase. This mode of action differs from that of penicillins. Organisms resistant to cephalosporins, aminoglycosides and tetracyclines are generally sensitive to Ciprofloxacin. Dosage and Administration General dosage recommendations The dosage of Ciprofloxacin is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient. Adults : The dosage range for adults is 100-750 mg twice daily. In infections of the urinary tract : 250-500 mg twice daily. In respiratory tract infections : 250-750 mg twice daily for both upper and lower respiratory tract infections. For the treatment of known Streptococcal pneumoniae infection, the recommended dosage is 750 mg twice daily. In gonorrhoea : a single dose of 250 or 500 mg. In the majority other infections, 500-750 mg twice daily should be administered. Cystic fibrosis : In adults with pseudomonal infections of the lower respiratory tract, the normal dose is 750 mg twice

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daily. As the pharmacokinetics of Ciprofloxacin remain unchanged in patients with cystic fibrosis, the low body weight of these patients would be fallen into consideration when determining dosage. Impaired renal function : Dosage adjustment are not usually required except in patients with severe renal impairment (serum creatinine >265 mol/l or creatinine clearance <20 ml/minute). If adjustment is necessary, this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provide the most reliable basis for dose adjustment. Dose adjustment Elderly : Although higher Ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary. Adolescents and children : As with other drugs in its class, Ciprofloxacin has been shown to cause arthropathy in weight bearing joints of immature animals. Although the relevance of this to man is unknown, its use in children, growing children and growing adolescents is not recommended. However, where the benefit of using Ciprofloxacin is considered to out weigh this potential risk, the dosage should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses. Duration of treatment The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days with Neofloxin tablets. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have disappeared. Contraindication Ciprofloxacin is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other quinolones. Ciprofloxacin is also contraindicated in children and growing adolescents except where the benefits of treatment exceed the risks. Warning and Precautions Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. Patients receiving Ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.

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Drug interactions Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated plasma concentrations of Theophylline and prolongation of its elimination half-life. This may result in increased risk of Theophylline related adverse reactions. If concomitant use cannot be avoided plasma levels of Theophylline should be monitored and dosage adjustments made as appropriate. Antacids containing Magnesium Hydroxide or Aluminium Hydroxide may interfere with the absorption of Ciprofloxacin resulting in serum and urine levels lower than desired, concurrent administration of these agents with Ciprofloxacin should be avoided. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly. As with other broad spectrum antibiotics prolonged use of Ciprofloxacin may result in overgrowth of nonsusceptible organism. Repeated evaluation of the patients condition and microbial susceptibility testing is essential. If superinfection occurs during therapy, appropriate measures should be taken. Information for Patients Patients should be advised that Ciprofloxacin may be taken with or without meals. The preferred time of dosing is two hours after a meal. Patients should also be advised to drink fluids liberally and not take antacids containing magnesium or aluminium concomitantly or within two hours after dosing. Ciprofloxacin may cause dizziness and lightheadedness, therefore patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination. Use in Pregnancy and Lactation Reproduction studies performed in mice, rats and rabbits using parenteral and oral administration did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri/post natal development. However as with other quinolones, Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mothers is thus not recommended. 261

Overdosage No information on overdosage is available. Routine measures such as gastric lavage should be performed as soon as possible after ingestion of Neofloxin tablets. Serum levels of Ciprofloxacin are reduced by dialysis. Side Effects Gastrointestinal : Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain. Central nervous system : Dizziness, headache, tiredness, confusion, convulsions. Hypersensitivity reactions : Skin rashes, pruritus and possible systemic reactions. The following other reactions have also been reported, joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage) serum bilirubin, urea or creatinine levels. Commercial Pack Neofloxin Tablet : Box containing 5 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 mg. Neofloxin-500 Tablet : Box containing 4 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg. Neofloxin-750 Tablet : Box containing 3 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 750 mg.

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Neopril
Tablet

Description Neopril is a preparation of Lisinopril USP. Neopril is available in potencies of 5 mg and 10 mg tablet. Indications Neopril (Lisinopril) is indicated for treatment of all grades of essential hypertension and renovascular hypertension, where standard therapy is ineffective or inappropriate because of adverse events. Neopril may be used alone or with other antihypertensive agents. Neopril is also indicated in the treatment of congestive heart failure as adjunctive therapy with non-potassium sparing diuretics and, where appropriate, with digitalis. Dosage and Administration Since absorption of Lisinopril is not affected by food, Neopril may be administered before, during or after meal. Essential Hypertension The usual recommended starting dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual effective maintenance dose is 20 mg administered in a single daily dose. The maximum dose used in long term, controlled clinical trial was 80 mg/day, but does not appear to give a greater effect. A lower starting dose is required in presence of renal impairment, in patients in whom diuretic therapy cannot be discontinued, patients who are volume and/or salt-depleted for any reason, and in patients with renovascular hypertension. Diuretic Treated Patients Symptomatic hypotension may occur occasionally following initial dose of Neopril. The diuretic should be discontinued, if possible, for two or three days before starting therapy with Lisinopril to reduce the likelihood of hypotension. 263

If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least 2 hours and until the blood pressure has stabilized for at least an additional hour. Use in Elderly Blood pressure response and adverse experiences were similar in younger and older patients. Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustment should be made with particular caution. Dosage Adjustment in Renal Impairment : Dosage adjustment should be based on creatinine clearance in case of renal impairment " Renal status Creatinine clearance ml/min mg/day 30 ml/min Initial dose

Normal Renal Function to mild impairment Moderate to severe impairment Dialysis Patients

10 mg

10-30 ml/min

5 mg

<10 ml/min

2.5 mg

Renovascular Hypertension Some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, may develop an exaggerated response to the first dose of Neopril. Therefore, a lower starting dose of 2.5 or 5 mg is recommended. Thereafter, the dosage may be adjusted according to the blood pressure response. Congestive Heart Failure In patients, not adequately controlled by digitalis and/or diuretics, Neopril may be added with a starting dose of 2.5 mg once a day. The

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usual effective dosage range is 5 to 20 mg per day administered in a single daily dose. Contraindication Neopril is contraindicated in pregnancy and treatment should be stopped if pregnancy is suspected, because it has been shown to be foetotoxic in rabbits. Neopril is also contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioneurotic oedema relating to previous treatment with an angiotensinconverting enzyme (ACE) inhibitor. Precautions Hypotension : Excessive hypotension was rarely seen in uncomplicated hypertensive patients. However, because of the potential fall in blood pressure in patients with severe congestive heart failure with or without associated renal insufficiency, therapy should be started under very close medical supervision. Such patients should be followed closely for the first two weeks of treatment and whenever the dose of Neopril and/or diuretic is increased. Similar considerations should be applied to patients with ischaemic heart disease or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. If hypotension occurs, the patient should be placed in supine position and if necessary receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses which usually can be given without difficulty once the blood pressure has increased after volume expansion. Renal Function Impairment : In patients with congestive heart failure, hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function. Reversible acute renal failure has been reported in this situation. Reversible increase of blood urea and serum creatinine have been reported in some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. 265

Hypersensitivity/Angioneurotic Oedema : Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with ACE inhibitors, including Neopril. In such cases lisinopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissal of the patient. In those instances where swelling is confined to the face and lips, the condition generally resolves without treatment, although antihistamines have been useful in relieving symptoms. Angioneurotic oedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis and larynx, likely to cause airway obstruction, appropriate therapy such as subcutaneous adrenaline solution 1:1000 (0.3 ml to 0.5 ml) should be administered promptly. Cough : Cough has been reported with the use of ACE inhibitors. Surgery/Anaesthesia : In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, Neopril may block angiotensin II formation, secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion. Paediatric Use : Safety and effectiveness of Lisinopril have not been established. Diuretics : When a diuretic is added to the therapy of a patient receiving Lisinopril, the antihypertensive effect is usually additive. Patients already on diuretics and especially those in whom diuretic therapy was recently instituted may occasionally experience an excessive reduction of blood pressure when Lisinopril is added. The possibility of symptomatic hypotension with Lisinopril can be minimized by discontinuing the diuretic prior to initiation of treatment with Lisinopril. Other Agents : Indomethacin may diminish the antihypertensive efficacy of concomitantly administered Lisinopril.

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Lisinopril has been used concomitantly with nitrates without evidence of clinically significant adverse interactions. Use in Pregnancy and Lactation There is no adequate and well controlled studies of Lisinopril in pregnant women. However, data are available that indicate that ACE inhibitors can cause foetal and neonatal morbidity and mortality when administered to pregnant women; therefore, the use of Lisinopril during pregnancy is not recommended unless needed in a situation where other drugs cannot be used or are ineffective. Lisinopril crosses the human placenta. Infants whose mothers have taken Lisinopril should be closely observed. It is not known whether exposure, limited to the first trimester, can adversely affect foetal outcome. However, complications including foetal hypotension, renal failure and oligohydramnios have been reported when Lisinopril was used during the later stages of pregnancy. Hyperkalaemia and/or skull hypoplasia has occurred with the use of other ACE inhibitors during the second and third trimesters. Maternal oligohydramnios, presumably representing decreased renal function in the foetus may result in limb contracture and craniofacial deformations. If oligohydramnios is observed Lisinopril should be discontinued unless it is considered life saving for the mother. It is not known whether Lisinopril is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if Lisinopril is given to nursing mother. Overdosage There is no data on overdosage in human. The most likely manifestation of overdose would be hypotension, for which the usual treatment would be intravenous infusion of normal saline. Lisinopril may be removed from the general circulation by haemodialysis. Side Effects The most frequent clinical side-effects of Lisinopril in controlled trials were dizziness, headache, diarrhoea, fatigue, cough and nausea. Other side effects occurring less frequently were orthostatic effects (including hypotension), rash etc.

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Cardiovascular : Myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients. Palpitation and tachycardia may be developed. Gastrointestinal tract : Abdominal pain, dry mouth, hepatitis, jaundice. Nervous system : Mood alteration, mental confusion. Respiratory tract : Bronchitis, pharyngeal pain. Special senses : Blurred vision. Urogenital tract : Uraemia, oliguria/anuria renal dysfunction, acute renal failure in rare cases. A symptom complex with Lisinopril has been reported which may include fever, vasculitis, myalgia, arthralgia/arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity or other dermatological manifestations may also occur. Pharmaceutical Precaution Store at room temperature. Commercial Pack Neopril-5 Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains Lisinopril USP equivalent to 5 mg anhydrous Lisinopril. Neopril-10 Tablet : Box containing 5 blister strips of 10 tablets, each tablet contains Lisinopril USP equivalent to 10 mg anhydrous Lisinopril.

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Neosten
Cream

Description Neosten (Clotrimazole) has a reliable action on dermatophytes, yeasts and other fungi. Neosten cream contains 1.0% Clotrimazole BP. Indications The confirmed indications for Neosten include : all dermatomycoses due to dermatophytes (e.g. Trichophyton species) all dermatomycoses due to yeasts (Candida species) dermatomycoses due to moulds and other fungi skin diseases showing superinfections with these fungi. The above mentioned dermatomycoses include interdigital mycoses (e.g. Athletes foot), paronychias (associated with nail mycoses), mycoses in skin folds, candida vulvitis, candida balanitis, pityriasis versicolour, erythrasma. Application and Usage Wash skin with soap and water and dry thoroughly. Apply a thin layer of the cream 2-3 times daily and gently massage over affected area as directed by the doctor. For Athletes foot, pay special attention to the spaces between the toes. Best results in Athletes foot and ringworm are usually obtained with 4 weeks use of this product. The cream should be applied two or three times daily for one month or for at least two weeks after the disappearance of all signs of infection. If satisfactory results have not occurred within these times consultation with doctor is essential. For best results, follow directions and continue treatment for length of time indicated. The duration of treatment varies; it depends among other factors on the extent and localization of the disease. Recommended duration of treatment : Dermatomycoses : Candida vulvitis and candida balanitis : Erythrasma and pityriasis versicolor (approx.) : 269 3-4 weeks 1-2 weeks 3 weeks

In fungal infection of the feet, to prevent relapses, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. Neosten cream is odourless, can be washed off and does not stain. Tolerance When applied topically Neosten cream is well tolerated. With external application systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful. Commercial Pack Neosten Cream : Tube containing 20 g cream, each gram contains Clotrimazole BP 10 mg.

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NeostenVT
Vaginal Tablet

Description Neosten VT acts reliably on dermatophytes, yeasts and other fungi; it is also effective against Trichomonas vaginalis and Gram-positive microorganisms (streptococci/staphylococci) and Gram-negative microorganisms (Bacteroides/Haemophilus vaginalis). Each Neosten vaginal tablet contains Clotrimazole BP 0.2 g. It has broad-spectrum antimycotic with fungicidal and trichomonacidal action. Indications Infectious vaginal discharge Vaginitis due to fungi (mainly Candida and/or Trichomonas) Superinfections with Neosten VT-sensitive bacteria Dosage and Application In general, a 3-day treatment is sufficient for candida vaginitis. On three consecutive nights, one Neosten vaginal tablet is inserted as deeply as possible into the vagina. This is best achieved when lying on ones back with the knees slightly bent. If necessary, one Neosten vaginal tablet daily can be used unhesitatingly for 6-12 days. Treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation. To avoid reinfection, the partner should undergo local treatment with Neosten cream at the same time. Tolerance Since there is practically no Neosten absorption through the vaginal skin, no systemic effects are expected. The local tolerance of Neosten vaginal tablets is generally good. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful. Experimental and clinical studies on the use of Neosten vaginal tablets during pregnancy gave no indication of harmful effect on mother and

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child. The use of Neosten VT during the last 4-6 weeks of pregnancy is recommended for the purpose of sanitation of the birth canal. Commercial Pack Neosten VT : Pack containing 3 vaginal tablets of Clotrimazole BP 0.2 g, each sealed in aluminium strip with applicator.

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Nightus
Tablet

Description Nightus tablet contains Bromazepam BP 3 mg. It is a global anxiolytic with smooth and superior efficacy. Unlike other benzodiazepines it has least side effects. Bromazepam reaches peak plasma concentrations within two hours after oral administration. Bromazepam is metabolized in the liver. It effectively removes anxiety and anxiety related various physiological problems. Indications Nightus is indicated for the following indications :

Emotional disturbance such as anxiety and tension states, for anxiety in depressed patients, nervous tension, restlessness anxiety and tension related insomnia. Functional disturbances of the cardiovascular and respiratory systems such as pseudo angina pectoris, tachycardia, hypertension, hyperventilation. Functional disturbances of the gastrointestinal tract such as irritable bowel syndrome, ulcerative colitis, epigastric pain, spasm. Other psychosomatic disturbances such as psychogenic headache.

Dosage and Administration Recommended dose is 1.5-12 mg three times daily. The dose depends on according to condition or patient response, and also side effect profile. Average outpatient dosage : 1.5-3 mg three times a day. Severe cases/hospital 5-12 mg two to three times daily. Reduce dose in half for elderly. Contraindication Bromazepam is contraindicated in patients with known hypersensitivity to benzodiazepines. It is also contraindicated in severe respiratory failure, myasthenia graves and severe liver failure.

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Precautions Bromazepam should be used cautiously in respiratory diseases, muscle weakness, and history of alcohol or drug abuse. Side Effects Drowsiness, lightheadedness in the next day, confusion, ataxia and amnesia may occur. Use in Pregnancy and Lactation The administration of Bromazepam is rarely justified in women and child bearing potential. Bromazepam should be avoided during breast feeding. Drug Interaction Phenothiazines, barbiturates, MAO inhibitors and psychoactive drugs may potentiate the action of Bromazepam and should not be given concurrently. Commercial Pack Nightus Tablet : Box containing 10 x 10 tablets in a blister pack. Each tablet contains Bromazepam BP 3mg.

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Noscab
Cream

Description Noscab cream is a preparation of 5% (w/w) Permethrin INN. Permethrin is a photo stable synthetic pyrethroid that possesses a broad spectrum of insecticidal activity and is generally rated as the safest insecticide because of its low primary toxicity. Along with the pediculicidal activity Permethrin has ovicidal and scabicidal activity. The insect rapidly absorbs Permethrin via mouth, respiratory tract or the intact cuticle. Although the primary target tissue is the nervous system, insects are killed by a complex series of reactions in various organs such as metabolic exhaustion and paralysis of the nervous system. Permethrin induces electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability in coordination and prostration. Indications Noscab is indicated for the treatment of scabies. Dosage and Application Adults and children (over 12 years)- A full tube Children aged 6-12 years- up to half of a tube Children aged 1-5 years- up to one fourth of a tube Children aged 2 months to 1 year- up to one eighth of a tube Patients of >2 months of age can use Noscab cream. Cream should be applied to clean, dry and cool skin. If the body is hot due to warm bath or any other reason, skin should be allowed to cool down. It should be applied to the whole body excluding head. The whole body should be washed thoroughly 8-12 hours after treatment. Adults and children above 12 years will use a full tube as a single dose. If necessary maximum two tubes can be used as a single dose. The cream should not be applied to the vicinity of mouth and areas close to the eyes. 275

Contraindication Permethrin is contraindicated in patients with known hypersensitivity to the product, its components, other pyrethroids or pyrethrins. Precautions Noscab is not an eye irritant, but the cream itself may cause marked irritation. Nursing staff who routinely apply Noscab, may wear gloves to avoid any possible irritation to the hands. Side Effects In scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Other transient effects are erythema, numbness, rash and pruritus. Overdosage There is no reports of overdosage with Permethrin. It is possible that excessive application of Permethrin might result in localized adverse reactions or more severe skin reactions. Drug Interactions The treatment of eczematous like reactions with corticosteroids should be withheld prior to treatment with Permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. Use in Pregnancy and Lactation There are limited data on the use of Permethrin in pregnancy which provide no indication of any risk to the foetus. Furthermore, the amount of Permethrin absorbed systemically following a whole body application is extremely low. The negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with Permethrin is minimal. Consideration should be given to discontinuing nursing temporarily or to withholding the drug while the mother is nursing, although drug levels in breast milk following topical application are likely to be very low. Commercial Pack Noscab Cream : Each pack has a tube containing 25 g of Noscab cream. Each gram contains Permethrin INN 50 mg. 276

Nuprafen
Tablet

Description Nuprafen (Naproxen), a non-steroidal anti-inflammatory agent, is a preparation of (+)-6-Methoxy-a-methyl-2-naphthalene acetic acid. It has analgesic, anti-inflammatory and antipyretic properties. It is an inhibitor of prostaglandin synthetase. Indications Nuprafen is indicated in mild to moderate pain such as dysmenorrhoea, migraine and for the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout, and acute musculoskeletal disorders. Dosage and Administration Adults : For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, the usual dose is 500 mg to 1 g per day taken in two divided doses at 12 hour intervals. For mild to moderate pain such as primary dysmenorrhoea, acute tendinitis and bursitis, the usual initial dose is 500 mg followed by 250 mg every 6 or 8 hours. The total daily dose should not exceed 1250 mg. In acute gout an initial dose of 750 mg followed by 250 mg every 8 hours has been suggested until the attack subsides. For juvenile arthritis : A dose of 10 mg/kg body weight daily in 2 divided doses in children over 5 years of age has been recommended. In the acute phase of the following cases a loading dose of 750 mg per day is recommended.

In patients reporting severe night time pain and morning stiffness. In patients being switched to Nuprafen (Naproxen) from a high dose of another anti-rheumatic compound. In osteo-arthrosis where pain is the predominant symptom.

277

Contraindication The drug is contraindicated in patients who are allergic to Naproxen or Naproxen Sodium. It is also contraindicated in patients in whom Aspirin or other non-steroidal anti-inflammatory/analgesic drug induce the symptoms of asthma, rhinitis and nasal polyps. Drug Interactions Due to the high plasma protein binding of Naproxen, patients simultaneously receiving Hydantoin, anti-coagulants or a highly protein bound sulphonamide should be observed for signs of overdosage of these drugs. Naproxen and other non-steroidal anti-inflammatory drugs (NSAIDs) can reduce the antihypertensive effect of Propranolol and other - blockers. Probenecid given concurrently, increases the plasma level of Naproxen and extends its plasma half life considerably. Side Effects Occasional skin rashes and angioedema have been reported. The following additional occurrences have been reported with Naproxen : nausea, vomiting, abdominal discomfort, epigastric distress, headache, inability to concentrate, insomnia, tinnitus and vertigo. Thrombocytopenia, jaundice, aplastic anaemia, haemolytic anaemia, peptic ulceration, fatal hepatitis, hearing impairment, cognitive dysfunction, anaphylactic reactions to Naproxen and Naproxen sodium formulations and nephropathy may occur rarely. Mild peripheral oedema has been observed in a few patients receiving Naproxen. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking Naproxen. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Naproxen should be used during pregnancy only if the potential benefits justify the potential risks to the foetus. The Naproxen anion has been found in the milk of lactating women. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers should be avoided. 278

Overdosage Significant overdosage of the drug may be characterized by drowsiness, heartburn, indigestion, nausea or vomiting. No evidence of toxicity has been reported 5-15 months after ingestion of the drug for three to seven days with doses up to 3 g/day. Pharmaceutical Precaution Protect from heat and direct sunlight. Commercial Pack Nuprafen 250 Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains 250 mg of Naproxen USP. Nuprafen 500 Tablet : Box containing 5 blister strips of 10 tablets, each tablet contains 500 mg of Naproxen USP.

279

Odrel
Tablet

Description Odrel (Clopidogrel) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Each tablet contains Clopidogrel Bisulfate INN equivalent to 75 mg Clopidogrel. Indications Odrel is indicated for the reduction of atherosclerotic events (myocardial infarction, stroke and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction or established peripheral arterial disease. Dosage and Administration The recommended dose of Odrel is 75 mg once daily with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease. Contraindication The use of Odrel is contraindicated in the following conditions : i) Hypersensitivity to any component of the product and ii) Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. Side Effects The most common clinically important side effects are pruritus, purpura, diarrhoea and rash. Infrequent events include intracranial haemorrhage (0.4%) and severe neutropaenia (0.04%). Use in Special Population Hepatic impaired patients : Odrel should be used with caution in this population. Paediatric patients : Safety and effectiveness in the paediatric population have not been established. 280

Pregnancy : Animal studies revealed no evidence of impaired fertility or foetotoxicity due to Clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of a human response, Odrel should be used during pregnancy only if clearly needed. Precautions As with other antiplatelet agents, Odrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions. If a patient is to undergo surgery and an antiplatelet effect is not desired, Odrel should be discontinued 7 days prior to surgery. Odrel prolongs the bleeding time. Patients should be told that it might take them longer than usual to stop bleeding when they take Odrel and that they should report any unusual bleeding to their physician. Drug Interactions Concomitant administration of Clopidogrel with NSAIDs, Warfarin or Heparin should be undertaken with caution. Overdosage No adverse events were reported after single oral administration of 600 mg (equivalent to 8 standard 75 mg tablets) of Clopidogrel in healthy volunteers. The bleeding time was prolonged by a factor of 1.7, which is similar to that typically observed with the therapeutic dose of 75 mg of Clopidogrel per day. If quick reversal is required, platelet transfusion may be appropriate to reverse the pharmacological effects. Pharmaceutical Precaution Store at temperature between 15o C and 30o C. Commercial Pack Odrel Tablet : Box containing 10 tablets in 1 x 10s blister strip. Each tablets contains Clopidogrel Bisulfate INN equivalent to 75 mg of Clopidogrel.

281

Omastin
Capsule/Suspension

Description Omastin (Fluconazole) is a triazole antifungal agent. It is a potent and selective inhibitor of fungal cytochrome P450 dependent enzymes necessary for the synthesis of ergosterol. Indications Vaginal Candidiasis Oropharyngeal Candidiasis Oesophageal Candidiasis Systemic Candidiasis and Cryptococcal infection Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea Kerion Pityriasis versicolor Onychomycosis Dosage and Administration Recommended dosages are given below, and this regimen is recommended from early infection to severe infections. 150 mg as a single dose or 200 mg in 1st day followed by 100 mg daily for 14 days
200 400

mg in 1st day followed by 100 mg daily for 14-30 days.

mg in 1st day followed by 200 mg daily for 28 days or longer based on clinical response mg weekly for 4-6 weeks mg as a single dose mg weekly for 12 months. mg daily for 20 days

150 50

400 150

Child over 1 year In Superficial Candidiasis- 1-2 mg/kg daily In Systemic Candidiasis and Cryptococcal infection- 3-6 mg/kg daily 282

In serious life threatening infections up to 12 mg/kg daily has been given to children aged 5-13 years (Maximum 400 mg daily) Age 1 year 1-2 years 2-3 years 3-4 years 4-6 years Average weight 9 kg 12 kg 14 kg 16 kg 20 kg Dose/Day spoonful 1 spoonful 1 spoonful 2 spoonful 2 spoonful

The daily dose of Omastin should be based on the nature and severity of the fungal infection. Most cases of fungal infections require multiple dose therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Immuno-compromised patients usually require maintenance therapy to prevent relapse. Other indications Fungal urinary tract infections Disseminated candidiasis Prophylaxis for fungal infection in neutropenic cancer patients. Acute treatment of other systemic fungal infections such as coccidioidomycosis and histoplasmosis Use in the Elderly The normal dose should be used if there is no evidence of renal impairment. Use in Renal Impairment No adjustment in single dose therapy is required. In multiple dose therapy of patients with renal impairment, normal doses should be given on days 1 and 2 of treatment and thereafter the dosage intervals should be modified as follows: Creatinine clearance Dosage interval (ml/min) (hours) >41 24 21-40 48 10-20 72 Patients receiving regular One dose after every dialysis dialysis session 283

Paediatric Use Few formal studies have been done in children. Doses of 3-6 mg/kg daily have been used without serious adverse reactions being reported. Renal clearance in children may be proportionately more rapid than in adults and doses up to 12 mg/kg is recommended. Effects on Liver For the liver as a potential target organ, the available data indicate that, Fluconazole is not predictable hepatotoxic drug in man. In man, including those with existing hypercholesterolaemia, serum cholesterol is not adversely affected by Fluconazole. Use in Pregnancy and Lactation Adverse foetal effects have been seen in animals only at doses ranging from 80 mg/kg to 320 mg/kg with maternal toxicity. These levels are 2060 times the recommended therapeutic use. Still Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the foetus. Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore, the use of fluconazole in nursing mother is not recommended. Contraindication Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds. Drug Interactions Fluconazole acts by inhibiting fungal cytochrome P450 enzymes. It is much less active against mammalian P450 enzymes, still potential exists for interaction with drugs that are metabolized by P450. Cyclosporin Some data suggest that Fluconazole increases cyclosporin levels. Phenytoin Fluconazole significantly increases Phenytoin levels. Anticoagulants Fluconazole has shown to prolong prothrombin time in subjects receiving Warfarin.

284

Oral hypoglycaemics Fluconazole has been shown to prolong the serum half life of concomitantly administered Tolbutamide. However no adverse effect on serum glucose levels was seen. Rifampicin Decreases levels of Fluconazole. Oral contraceptives No clinically significant interactions have been seen.

Side Effects Therapy with Fluconazole is well tolerated. In 4000 patients receiving Fluconazole for various indications and for durations of 7 days or more, the incidence of side effects were 16% . Only 1.5% of subjects required discontinuation of medication. The most common adverse events were related to the gastrointestinal system : nausea (3.7%), abdominal pain (1.17%), vomiting (1.7%) and diarrhoea (1.5%). Headache (1.9%) and skin rash (1.8%) were also seen. It should be noted that approximately one third of this group were patients with acquired immunodeficiency syndrome (AIDS) and severe systemic disorders. Therefore the data may not be applicable to patients receiving Fluconazole for the treatment of superficial mycoses. Overdosage In the case of overdose, supportive measures and gastric lavage should be instituted. If deemed necessary, a 3 hours haemodialysis will decrease plasma levels by about 50%. Pharmaceutical Precaution Omastin should be stored below 30C. Commercial Pack Omastin-50 Capsule : Box containing 5 aluminium strips of 10 capsules, each capsule contains Fluconazole INN 50 mg. Omastin-150 Capsule : Box containing 2 blister strips of 10 capsules, each capsule contains Fluconazole INN 150 mg. Omastin Suspension : Dry powder in glass bottle for reconstitution into 35 ml of suspension. After reconstitution, each 5 ml contains Fluconazole INN 50 mg. 285

Opton
Tablet

Description Esomeprazole is the S-isomer of Omeprazole. It reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Each enteric coated tablet contains 20 mg Esomeprazole INN (as Magnesium Trihydrate). Indications Healing of erosive oesophagitis Long-term management of Oesophagitis Symptomatic gastro-oesophageal reflux disease (GERD) H. pylori Eradication for treatment of duodenal ulcer. (Triple Therapy with Esomeprazole, Clarithromycin and Amoxicillin). Dosage and Administration Healing of erosive oesophagitis : 20 mg or 40 mg once daily for 4 to 8 Weeks. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 week course of Esomeprazole may be considered. Long-term management of oesophagitis : 20 mg once daily. Symptomatic GERD : 20 mg once daily for 4 weeks. H. pylori eradication for treatment of duodenal ulcer : Triple Therapy- 20 mg Esomeprazole once daily with 500 mg Clarithromycin twice daily, and 1 g Amoxicillin twice daily for 7-10 days. Contraindication Patients with known hypersensitivity to any component of the formulation. Side Effects In general, Esomeprazole is well tolerated in both short and long-term use. Common adverse events are headache and diarrhoea. Other side 286

effects include nausea, flatulence, abdominal pain, constipation, and dry mouth. Use in Special Population Geriatric : Dosage adjustment is not necessary. Pediatric : Safety and effectiveness in paediatric patients have not been established. Hepatic Insufficiency : No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency a dose of 20 mg once daily should not be exceeded. Renal Insufficiency : Dosage adjustment is not necessary. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. The excretion of Esomeprazole in human milk has not been studied. Because Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue the drug. Overdosage There is no experience to date with deliberate overdose. Data are limited but single doses of 80 mg Esomeprazole were uneventful. Esomeprazole is extensively plasma protein bound and is therefore not readily dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized. Drug Interactions Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Digoxin). Pharmaceutical Precaution Store at temperature between 15C and 30 C.

287

Commercial Pack Opton Tablet : Box containing 3 x 10 tablets in aluminium form pack. Each tablet contains 20 mg Esomeprazole INN as (Magnesium Trihydrate).

288

Pacet
Tablet

Description Pacet (Amiodarone Hydrochloride) is used to correct abnormal rhythms of the heart. Amiodarone is considered a "broad spectrum" antiarrhythmic medication. The most important electrical effects of the drug includes : a delay in the rate at which the hearts electrical system "recharges" after the heart contracts (repolarization); a prolongation in the electrical phase during which the hearts muscle cells are electrically stimulated (action potential); a slowing of the speed of electrical conduction (how fast each individual impulse is conducted through the hearts electrical system); a reduction in the rapidity of firing of the normal generator of electrical impulses in the heart (the hearts pacemaker); and a slowing of conduction through various specialized electrical pathways (called accessory pathways). In addition to being an antiarrhythmic medication, Amiodarone also causes blood vessels to dilate. Because of this effect it also may be of benefit in patients with congestive heart failure. This effect can result in drop of blood pressure. Indications Amiodarone is used for many serious arrhythmias of the heart including ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter. Dosage Oral dose is 200 mg 3 times daily for 1 week reduced to 200 mg twice daily or the minimum required to control arrhythmia. Amiodarone is usually given in several daily doses to minimize stomach upset which is seen more frequently with higher doses. For this same reason, it is also recommended that Amiodarone should be taken with meals. Side Effects The most severe side effects of Amiodarone therapy are related to the lungs. These reactions can be fatal. Patients should report any symptoms of cough, fever, or painful breathing. Although quite rare, fatal liver toxicity may occur with Amiodarone therapy. 289

Reversible corneal microdeposits (sometimes with night glare), rarely impaired vision due to optic neuritis; peripheral neuropathy and myopathy (usually reversible on withdrawal); bradycardia and conduction disturbances; phototoxicity and rarely persistent skin discolouration; hypothyroidism, hyperthyroidism; raised serum transaminases; jaundice, hepatitis and cirrhosis are reported. Other rare complaints are nausea, vomiting, metallic taste, tremor, sweating, vertigo, headache, sleeplessness, fatigue, alopecia, benign raised intracranial pressure, ataxia, rashes, vasculitis, renal involvement, thrombocytopenia, haemolytic or aplastic anaemia. In some cases, dose of Amiodarone may be reduced. In other cases, Amiodarone therapy may need to be stopped. Use in Pregnancy and Lactation In general, Amiodarone should not be administered during pregnancy because there have been reports of hypo- or hyperthyroidism in infants from oral Amiodarone use during pregnancy. If Amiodarone use is considered essential, however, the patient should be warned of the risk to the foetus. The safe use of Amiodarone in lactating women has not been established. Drug Interactions Amiodarone may interact with -blockers such as Atenolol, Propranolol, Metoprolol, or certain calcium channel blockers, such as Verapamil or Diltiazem, resulting in an excessively slow heart rate. Amiodarone increases the blood levels of Digoxin when the two drugs are given together. Flecainide blood concentrations increase by more than 50% with Amiodarone. Procainamide and Quinidine concentrations increase by 30-50% during the first week of Amiodarone therapy. Amiodarone also can interact with tricyclic antidepressants (TCA). Amiodarone interacts with Warfarin and increases the risk of bleeding. Amiodarone inhibits the metabolism of Dextromethorphan. Pharmaceutical Precaution Tablets should be kept at room temperature, less than 30 C.

290

Commercial Pack Pacet 100 Tablet : Box containing 3 x 10s tablets in blister strips. Each tablet contains Amiodarone Hydrochloride BP 100 mg. Pacet 200 Tablet : Box containing 3 x 10s tablets in blister strips. Each tablet contains Amiodarone Hydrochloride BP 200 mg.

291

Pedeamin
Syrup

Description Amber glass bottle containing 100 ml syrup. Each 5 ml contains 10 mg Diphenhydramine Hydrochloride BP. Indications Pedeamin is indicated for the treatment of following : Seasonal, perennial, vasomotor rhinitis Urticaria, angioneurotic oedema, anaphylaxis Pruiritic conditions Premedication for emesis and motion sickness Miscellaneous include Mnires disease and parkinsonism Dosage and Administration Adult Most allergic conditions are controlled in adult with 25-50 mg three times a day with a further 50 mg at night. Children 1 to 5 years of age : 5 mg i.e., 2.5 ml of elixir 4 times a day

More than 6 years of age : 10 mg i.e. 5 ml of elixir 4 times a day

Contraindication Any patients in whom drowsiness is undesirable e.g. drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness. Patients with known hypersensitivity to Diphenhydramine or any components of the product. Care should be taken in administration during pregnancy. Use in Pregnancy and Lactation Diphenhydramine cross the placenta. There has been a suggestion that Diphenhydramine ingestion during pregnancy is associated with a higher incidence of cleft palate. As for all drugs care should be taken when prescribing Diphenhydramine during pregnancy and lactation. 292

Side Effects Side-effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort. Drug Interactions Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative Diphenhydramine. Anticholinergic drugs may Diphenhydramines anticholinergic side effects. action of potentiate

Commercial Pack Pedeamin Syrup : Amber glass bottle containing 100 ml syrup. Each 5 ml contains 10 mg Diphenhydramine Hydrochloride BP.

293

Pregvit
Capsule

Description Pregvit is a special preparation of Iron, Folic Acid, Vitamin B complex, and Vitamin C. Iron is presented in timed release form to escape gastric irritation. Each extended release capsule contains : Ferrous Sulphate BP 150 mg Folic Acid USP 0.5 mg Thiamine Mononitrate (vitamin B1) USP 2 mg Riboflavin (vitamin B2) USP 2 mg Nicotinamide (vitamin B3) USP 10 mg Pyridoxine Hydrochloride (vitamin B6) USP 1 mg Ascorbic Acid (vitamin C) USP 50 mg Indications and Uses Pregvit is indicated for the treatment and prophylaxis of Iron, Folic Acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy. Dosage and Administration Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician. Contraindication This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not not due to by iron deficiency. Should be given cautiously to patients taking Levodopa as one of the ingredients of Pregvit (Pyridoxine) reduces the effect of Levodopa. Side Effects Generally well tolerated. However, a few gastrointestinal disorders and allergic reactions may be occurred.

294

Use in Pregnancy and Lactation It is recommended during pregnancy and lactation. Drug Interactions Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently. Overdosage Overdosage of Iron is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, vomiting may also be induced. Pharmaceutical Precaution Store in a dry place below 25C. Protect from light and Keep out of reach of children. Commercial Pack Pregvit Capsule : Each box contains 5 blister strips of 10 capsules each. Each extended release capsule contains Ferrous Sulphate BP 150 mg, Folic Acid USP 0.5 mg, Thiamine Mononitrate (vitamin B1) USP 2 mg, Riboflavin (vitamin B2) USP 2 mg, Nicotinamide (vitamin B3) USP 10 mg, Pyridoxine Hydrochloride (vitamin B6) USP 1 mg, Ascorbic Acid (vitamin C) USP 50 mg.

295

Premil
Tablet

Description The active ingredient of Premil is Repaglinide. Repaglinide belongs to a new class of oral antidiabetic drug called meglitinide which stimulates insulin release from -cells of pancreas. Indications Premil is indicated as an adjunct to diet and exercise to lower the blood glucose level in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone. Mechanism of Action Repaglinide binds to specific receptors in the -cell membrane leading to the closure of ATP-dependent K+ channels and the depolarization of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca+ + and the stimulation of insulin secretion. Therapeutic Advantage Premil is taken in relation to meal i.e. one meal one dose, no meal no dose. Many oral blood glucose-lowering drugs release insulin throughout the day, irrespective of taking meal or not. This may lead to hypoglycaemia if a meal is missed or delayed. But Premil is different because it is taken before meals. Premil begins to work very quickly to increase insulin level while the food is digested and glucose enters the blood stream. Premil helps body release insulin to handle the blood glucose from that meal. Premil leaves the blood stream quickly, so that body doesnt keep releasing insulin. Thus it helps to release insulin when it is needed. Moreover, it gives the flexibility to plan medication around meals instead of planning meals around medication. Dosage and Administration Premil has to be taken just before or up to 30 minutes before the meal. Premil can be taken two, three or four times a day, depending on how 296

many meals are taken. If a meal is missed, Premil should also be avoided. If an extra meal is taken, an extra dose of Premil should be taken with that meal. If a dose of Premil is missed, it should not be taken between meals. Rather the usual dose should be taken before the next meal. The dose ranges from 0.5 to 4 mg before each meal. The starting dose of Repaglinide in patients with HbA1c <8% is 0.5 mg before each meal. In patients with HbA1c >8% the starting dose is 1 or 2 mg before each meal. The dose may be increased gradually up to 4 mg before each meal. Side Effects Hypoglycaemia is possible with all blood glucose-lowering drugs. If there are symptoms of low blood glucose (for example, headache, dizziness, tiredness, nervousness or shakiness, rapid heartbeat, or nausea), blood glucose should be tested right away. If it is low (less than 70 mg/dl on a home glucose meter), a simple carbohydrate food (for example, orange juice, quick-dissolving sugar, candies, or glucose tablets) should be taken. If the symptoms do not go away, doctor should be informed. Some of the other common symptoms reported by patients taking Repaglinide include cold and flu-like symptoms, diarrhoea, joint ache, and back pain. There is some evidence that oral diabetes drugs may increase the risk of heart problems. But experts are not sure what the real risk is, if any, from taking oral diabetes medicine. Drug Interactions The dose of Premil may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are : i) Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life. ii) Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect. iii) Cimetidine has no significant effect on Repaglinide absorption or clearance. iv) Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin. v) Highly protein-bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose-lowering effect. Thus, co-administration of these drugs with Repaglinide may 297

increase the risk of hypoglycaemia. vi) The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulfonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and beta adrenergic blockers. Contraindication Premil is contraindicated in patients with diabetic ketoacidosis, with or without coma, in patients with type I diabetes and in patients with known hypersensitivity to any of the components of the product. Precautions Premil should also be used with caution in renal and hepatic insufficiency. In pregnancy, safety of Repaglinide has not been established. Hence, Premil should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. Accidental Overdosage In clinical trials patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycaemia did not occur when meals were given with these high doses. Hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycaemia may recur after apparent clinical recovery. There is no evidence that Repaglinide is dialysable using haemodialysis. Severe hypoglycaemic reactions with coma, seizure or other neurological impairment occur infrequently but constitute medical emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl.

298

Pharmaceutical Precaution Premil should be stored at room temperature away from moisture. Like all other medications, Premil should be kept out of the reach of children. Commercial Pack Premil 0.5 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Repaglinide USP 0.5 mg. Premil 1 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Repaglinide USP 1 mg. Premil 2 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Repaglinide USP 2 mg.

299

Pretin
Tablet

Description Pretin is a potent, rapidly effective and long-acting non-sedative, histamine H1 receptor antagonist, with anti-allergic properties. Each tablet contains 10 mg of Loratadine INN. Indications Pretin is indicated for Seasonal allergic rhinitis Perennial allergic rhinitis Sneezing, rhinorrhoea and itching Ocular itching and burning Chronic urticaria and other allergic dermatologic disorders Dosage and Administration Adult and children above 12 years of age : 10 mg (1 Pretin tablet) oncea-day Children 6 - 12 year 2 - 5 year

: 10 mg (1 Pretin tablet) once-a-day : 5 mg ( Pretin tablet) once-a-day

Safety and efficacy of Loratadine in children below 2 years of age have not yet been established. Contraindication Loratadine is contraindicated in patients who have hypersensitivity or idiosyncrasy to any of its component. Side Effects Potentially life threatening effects : No effects of this kind have been encountered. Acute overdose : No cases of acute overdose have been reported.

300

Severe or irreversible side effects : No effects of this kind have been reported. Symptomatic side effects : Clinical trials suggest a very low rate of adverse effects, comparable to placebo, in particular for CNS effects (including sedation) and anticholinergic activity. The lack of sedation by Loratadine was further confirmed by special psychomotor studies such as the driving performance test. Precautions Neonates : The drug is not normally used in neonates Lactating mothers : Like other H1 receptor antagonists, Loratadine is also excreted in breast milk, so lactating mothers are advised not to take the drug. Children : There are no special precautions required for young children over 2 years. But the safety and efficacy of Loratadine in children below 2 years of age have not yet been established. Pregnant women : Although Loratadine was not found to be teratogenic in animals, safe use of Loratadine during pregnancy has not been established. There have been no case reports of any adverse foetal consequences. The drug should be used only if the potential benefit justifies the potential risk to the foetus. Drug Interactions There are no reports of potentially hazardous interactions with other drugs to date. Psychomotor performance studies show that unlike other H 1 receptor antagonists, Loratadine does not potentiate the effect of alcohol when administered concomitantly with it. Commercial Pack Pretin Tablet : Box containing 10 blister strips of 10 tablets. Each tablet contains Loratadine INN 10 mg.

301

Primace
Capsule

Description Primace (Ramipril) is an angiotensin-converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by Ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus Ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated, so, can be used in long term therapy. Indications Primace is indicated in the following cases- Mild to severe hypertension - Heart failure. - To reduce the risk of stroke, myocardial infarction and death from cardiovascular events in patients with a history of cardiovascular disease. Dosage and Administration Hypertension: For the management of hypertension initial dose of Primace is 1.25 mg daily, can be increased with an interval of 1-2 weeks; usual dosage range is 2.5-5 mg daily up to a maximum of 10 mg daily. Heart failure: In this case initial dose of Primace is 1.25 mg once daily under supervision; dosage can be increased at intervals of 1-2 weeks; maximum of 10 mg daily can be taken and if necessary in 2 divided doses. For prophylaxis and after myocardial infarction (3-10 days after infarction): Initial dose of Primace is 2.5 mg twice daily; can be increased to 5 mg twice daily after 2 days; 2.5 mg to 5 mg twice daily for maintenance. Dosage in renal impairment: For the patient with hypertension and renal impairment the recommended initial dose is 1.25 mg Primace once daily. 302

Subsequent dosage should be titrated according to individual tolerance and blood pressure response, up to a maximum of 5 mg daily. For the patients with heart failure and renal impairment, the recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability. Contraindication Ramipril is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with ACE inhibitor. Precautions Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function. Side Effects Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely. Use in Pregnancy and Lactation Insufficient data is available for the use of Ramipril in pregnant and lactating mothers. Therefore, the use of Ramipril in pregnancy and lactation is not advisable. Use in Children No information is yet available in the use of Ramipril in children. Drug Interactions Concomitant administration with diuretics may lead to serious hypotension, and in addition dangerous hyperkalaemia with potassium sparing diuretics. Concomitant therapy with Lithium may increase the serum Lithium concentration. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.

303

Overdosage Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Because the hypotensive effect of Ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat Ramipril overdose by infusion of normal saline solution. Commercial Pack Primace 1.25 Capsule : Box contains 3 blister strips of 10 capsules. Each capsule contains 1.25 mg of Ramipril BP. Primace 2.50 Capsule : Box contains 3 blister strips of 10 capsules. Each capsule contains 2.50 mg of Ramipril BP. Primace 5 Capsule : Each box contains 3 blister strips of 10 capsules. Each capsule contains 5 mg of Ramipril BP.

304

Proceptin -20
Capsule

Description Proceptin capsule contains 20 mg of Omeprazole BP as enteric coated granules. Indications Proceptin offers significant therapeutic gains in the treatment of acid related diseases. Healing rates are high in duodenal ulcer, gastric ulcer and erosive reflux oesophagitis; acid production is controlled effectively in Zollinger-Ellison Syndrome, and symptom relief is prompt and sustained in all indications. Less clear-cut indications where benefit might be expected but where data are limited include : Prevention of stress ulceration, Prevention of acid aspiration syndrome and Treatment of upper gastrointestinal bleeding. Note : In comparative studies, Omeprazole has been found to produce faster symptom relief and higher healing rates in a greater percentage of patients than either Cimetidine or ranitidine, confirming the therapeutic gains achievable with Proceptin over existing therapies. Dosage and Administration Duodenal ulcer : 20 mg once daily for 4 weeks. In severe cases, 40 mg once daily for 4 weeks. Gastric ulcer : 20 mg once daily for 8 weeks. In severe cases, 40 mg once daily for 8 weeks. Erosive Reflux Oesophagitis : 20 mg once daily for 4 weeks. For those not fully healed, to be continued for 4 more weeks. Refractory Reflux Oesophagitis : 40 mg once daily for 8 weeks. Zollinger-Ellison Syndrome : 60 mg once daily, adjusted individually and continued as long as necessary.

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Most patients will be effectively controlled with 20-120 mg daily. Dosage above 80 mg should be divided and given twice daily. Long-term maintenance treatment with Proceptin is not recommended. Impaired renal or hepatic function : Adjustment is not required. Patients with severe liver disease should not require more than 20 mg Omeprazole daily. Contraindication Omeprazole capsule is contraindicated in patients with known hypersensitivity to any component of the formulation. Use in Pregnancy and Lactation There are no adequate or well controlled studies in this group of patients. Omeprazole should not be given during pregnancy and lactation unless its use is considered essential. Paediatric Use Safety and effectiveness in children have not been established. Adverse Effects Side effects reported with Omeprazole in clinical studies have included nausea, diarrhoea, constipation, flatulence, abdominal colic, paraesthesia, dizziness and headache but are rare. Skin rashes, leucopenia and transient elevation of plasma activation of hepatic amino-transferases have been observed occasionally in few patients and there has been no consistent relationship with treatment. Toxicology In two 24-months carcinogenicity studies in rats, Omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (approximately 4 to 352 times the human dose, based on a patient weight of 50 kg and a human dose of 20 mg) produced gastric entero-chromaffin like (ECL) cell carcinoids in a dose related manner in both male and female rats. No treatment related mucosal changes have been observed in patients treated continuously for periods up to 4 years. Precautions Symptomatic responses to therapy with Omeprazole does not preclude the presence of gastric malignancy.

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Warning In long-term (2 years) studies in rats, Omeprazole produced a dose related increase in gastric carcinoid tumours. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to Omeprazole, further human data on the effects of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumours in humans receiving long-term therapy with Omeprazole. Drug Interactions Omeprazole can delay the elimination of Diazepam, Phenytoin and Warfarin. Monitoring of patients receiving Warfarin or Phenytoin is recommended and a reduction of Warfarin or Phenytoin dose may be necessary when Omeprazole is added to treatment. Omeprazole does not interfere with Theophylline or Propranolol metabolism. Information for Patients Proceptin should be taken before meals. Patients should be cautioned that the capsules should not be opened, chewed or crushed and should be swallowed whole. Commercial Pack Proceptin-20 Capsule : Box contains 3 blister strips of 10 capsules, each capsule contains 20 mg of Omeprazole BP as enteric coated granules.

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Prosan
Tablet

Description Prosan (Losartan Potassium) is an angiotensin-II receptor (type AT1) antagonist. Angiotensin-II is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT1 receptor found in many tissues. Indications It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Dosage and Administration The usual starting dose is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. It can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg. Contraindication Losartan Potassium is contraindicated in patients who are hypersensitive to the active ingredient or any component of the drug. Adverse Reactions In clinical trials, dizziness was the only side effect reported that occurred with an incidence greater than placebo in 1% patients treated with Losartan. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo. Angioedema, involving swelling of the face, lips and/or tongue, has been reported rarely in patients treated with Losartan. The incidence of cough is similar to placebo and significantly lower than that observed with ACE inhibitors.

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Use in Special Population Children : There are no data on the safety or efficacy of Losartan in children. Pregnant women : Prosan must be discontinued as soon as possible when pregnancy is detected. It should not be prescribed during lactation, as there is no information in human on the passage of Losartan into breast milk. Elderly : In elderly patients up to 75 years of age, no dosage adjustment is necessary. Drug Interactions No drug interactions of clinical significance have been identified. Compounds that have been studied in clinical pharmacokinetic trials include Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine, Ketoconazole, and Phenobarbital. Overdosage Limited data are available regarding overdosage in human. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should include repletion of the intravascular fluids. Pharmaceutical Precaution Store in a dry place, at temperature between 15 oC and 30 oC. Keep away from light. Commercial Pack Prosan 25 Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Losartan Potassium INN 25 mg. Prosan 50 Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Losartan Potassium INN 50 mg.

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Prosfin
Tablet

Description Prosfin is a preparation of Finasteride, a competitive inhibitor of the 5reductase enzyme which is used in the treatment of benign prostatic hyperplasia. It is selective for 5 -reductase type-2 enzyme and has no affinity for androgen receptors. Indications Prosfin is indicated for the treatment and control of benign prostatic hyperplasia (BPH) to cause regression of the enlarged prostate to improve urinary flow to improve the symptoms associated with BPH. Mode of Action The development of the prostate gland and subsequent BPH is dependent upon conversion of testosterone to dihydrotestosterone (DHT) within the prostate. Prosfin belongs to a new class of specific inhibitors of 5-reductase, an intracellular enzyme, which metabolizes testosterone into the more potent androgen, DHT. Finasteride has no affinity for the androgen receptor. Dosage and Administration The recommended dosage is one 5 mg tablet daily. Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued. Use in renal insufficiency : Dosage adjustments are not necessary in patients with renal insufficiency since pharmacokinetic studies did not indicate any change in the disposition of Finasteride. Use in hepatic insufficiency : There are no data available in patients with hepatic insufficiency. Use in the elderly : No dosage adjustment is required in elderly patients. 310

Precautions General : Since the beneficial response to Finasteride may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. Prostate cancer : Digital rectal examination, as well as, other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Finasteride and periodically thereafter. Finasteride causes a decrease in serum concentration of markers of prostatic cancer such as prostate specific antigen (PSA); therefore, reduction of serum levels of these markers in patients with BPH treated with Finasteride does not rule out concomitant prostate cancer. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Finasteride. Contraindication Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient. Warning Crushed or broken Finasteride tablets should not be handled by women who are or may become pregnant; in addition, since it is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partner who have the potential to become pregnant. Pharmaceutical Precaution Store at room temperature below 30 C. Protect from light. Drug Interactions No clinically important drug interactions have been identified. Finasteride does not appear to significantly affect the cytochrome P450 linked drug metabolizing enzyme system. Compounds which have been tested in man include Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline, and antipyrine. Side Effects Finasteride is well tolerated. In clinical studies, the following adverse experiences have been reported as possibly drug related in 1% of patients

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treated for 12 months with 5 mg Finasteride daily : impotence (3.7%), decreased libido (3.3%), and decreased volume of ejaculate (2.8%). Overdosage No specific treatment of overdosage with Finasteride is recommended. Patients have received single doses of Finasteride up to 400 mg and multiple doses of Finasteride up to 80 mg/day for up to three months without any adverse effects. Commercial Pack Prosfin Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Finasteride USP 5 mg.

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Protolan
Capsule

Description Protolan (Lansoprazole) is a proton pump inhibitor. It is an irreversible inhibitor of the parietal cell H+-K+ ATPase, which leads to profound inhibition of gastric acid secretion. Indications Duodenal ulcer Gastric ulcer Oesophagitis/Ulceration Zollinger-Ellison syndrome Resistant ulcers and oesophagitis Eradication of Helicobacter pylori in the treatment of peptic ulcer (in combination with antibiotics) Dosage and Administration Benign gastric ulcer : 30 mg daily in the morning for 8 weeks

Duodenal ulcer : 30 mg daily in the morning for 4 weeks; maintenance 15 mg daily NSAID-associated duodenal or gastric ulcer : 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed Zollinger-Ellison syndrome (and other hypersecretory conditions) : Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses Gastro-oesophageal reflux disease : 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily Acid-related dyspepsia : 15-30 mg daily in the morning for 2-4 weeks.

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Contraindication The use of Protolan is contraindicated in patients with a history of hypersensitivity to any of the ingredients of Protolan capsule. Side Effects Potentially life-threatening effects : None has been recorded. Acute overdosage : None has been reported. Severe or irreversible adverse effects : The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long- term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis. Symptomatic adverse effect : Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients. Use in Special Population Neonates : There is no relevant human data. The drug is not recommended for use in neonates. Children : The youngest person to have received Lansoprazole in clinical trials was 13 years old. Pregnant women : There is no relevant human data. The elderly : No problems have been encountered in clinical use and there has been no increase in adverse drug reaction in the elderly. Drug Interactions Lansoprazole appears to be a selective inhibitor of the cytochrome P450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the oral combined contraceptive pill.

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Commercial Pack Protolan-15 Capsule : Box containing 30 capsules in 3 x 10s blister strips. Each capsule contains Lansoprazole USP 15 mg as enteric coated granules. Protolan-30 Capsule : Box containing 30 capsules in 3 x 10s blister strips. Each capsule contains Lansoprazole USP 30 mg as enteric coated granules.

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Recox
Tablet

Description Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID). By selectively inhibiting the cyclooxygenase-2 (COX-2) enzyme, it shows analgesic, antipyretic, and anti-inflammatory action. Indications For the treatment of acute mild or moderate pain including bone pain, dental pain, and orthopaedic surgical pain For the treatment of primary dysmenorrhoea For the relief of the signs and symptoms of osteoarthritis For the relief of the signs and symptoms of rheumatoid arthritis Dosage and Administration Recox is administered orally. The lowest dose of Recox should be sought for each patient. For the relief of acute pain and treatment of primary dysmenorrhoea : The recommended initial dose of Rofecoxib is 50 mg once daily. Subsequent doses should be 25 to 50 mg once daily. The maximum recommended daily dose is 50 mg. Osteoarthritis : The recommended starting dose of Rofecoxib is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. The maximum recommended daily dose is 25 mg. Rheumatoid arthritis :The recommended dose of Rofecoxib is 50 mg once daily. The maximum recommended daily dose is 50 mg twice daily. Contraindication Recox is contraindicated in patients with known hypersensitivity to Rofecoxib. Recox should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs. 316

Side Effects Common side effects of Rofecoxib, with an incidence greater than placebo include : dizziness, sinusitis, back pain, fatigue, and bronchitis. Infrequent side effects are headache, maculopapular rash, dermatitis, and anorexia. Use in Special Population Geriatric : Dose adjustment in the elderly is not generally necessary. However, therapy should be initiated at the lowest recommended dose. Paediatric : The safety and efficacy of Rofecoxib is not established in paediatric patients. Hepatic Insufficiency : No dosage adjustment is required in patients with mild to moderate hepatic insufficiency. The safety and efficacy of Rofecoxib in patients with severe hepatic impairment have not been studied. Pregnancy : In third trimester of pregnancy, Rofecoxib should be avoided because it may cause premature closure of the ductus arteriosus. Precautions Recox can be administered with or without food. Drug Interactions ACE Inhibitors : Reports suggest that non-steroidal anti-inflammatory drugs (NSAIDs) may diminish the antihypertensive effect of angiotensinconverting enzyme (ACE) inhibitors. Aspirin : Concomitant administration of low-dose Aspirin with Rofecoxib may result in an increased rate of gastrointestinal ulceration or other complications, compared to use of Rofecoxib alone. Frusemide : Clinical studies have shown that NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients. Lithium : NSAIDs have produced an elevation of plasma Lithium levels and a reduction in renal Lithium clearance. Thus, when Rofecoxib and

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Lithium are administered concurrently, subjects should be observed carefully for signs of Lithium toxicity. Rifampicin : Co-administration of Rofecoxib with Rifampicin 600 mg daily may produce a 50% decrease in Rofecoxib plasma concentrations. Warfarin : Anticoagulant activity should be monitored, particularly in the first few days after initiating or changing Rofecoxib therapy in patients receiving Warfarin or similar agents. Bleeding events and increases in prothrombin time, have been reported, predominantly in the elderly patients. Overdosage Administration of up to 1000 mg of Rofecoxib per day did not result in serious toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. Pharmaceutical Precaution Store at temperature between 15o C and 30o C. Commercial Pack Recox 12.5 Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Rofecoxib INN 12.5 mg. Recox 25 Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Rofecoxib INN 25 mg. Recox 50 Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Rofecoxib INN 50 mg.

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Recur
Tablet

Description Recur is a preparation of Finasteride, a competitive inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone into 5-dihydrotestosterone (DHT). Mode of Action Finasteride is a competitive and specific inhibitor of Type II 5reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Finasteride has no affinity for the androgen receptor and has no androgenic or antiandrogenic effects. Inhibition of Type II 5 reductase blocks the conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. In men with male pattern hair loss, the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp. Administration of Finasteride decreases scalp and serum DHT concentrations in these men. Indications Recur is indicated for the treatment of male pattern hair loss (androgenic alopecia) in MEN ONLY. Dosage and Administration The recommended dosage is 1 mg once a day. Recur may be administered with or without meals. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit. Withdrawal of treatment leads to reversal of effect within 12 months. Contraindication Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient. Precautions Caution should be used in the administration of Recur in patients with liver function abnormalities, as Finasteride is metabolized extensively in

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the liver. Women who are or may potentially be pregnant should not handle crushed or broken tablets of Recur. Drug Interactions No drug interactions of clinical importance have been identified. Side Effects Finasteride is well tolerated. In clinical studies, the following adverse reactions were reported as possibly drug related in >1% of patients treated for 12 months with Finasteride 1 mg daily : decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) and decreased volume of ejaculate (0.8%). Overdosage In clinical studies, single dose of Finasteride up to 400 mg and multiple doses of Finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with Finasteride can be recommended. Pharmaceutical Precaution Store at room temperature, 15o to 30 oC. Protect from moisture. Commercial Pack Recur Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Finasteride USP 1 mg.

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Reflon
Tablet

Description Reflon film coated tablet contains Glucosamine Hydrochloride USP. Glucosamine is a naturally occurring compound for the body's production of point lubricants and shock-absorbers necessary to maintain healthy cartilage and joint function. Glucosamine Hydrochloride is a prodrug for glucosamine that is well absorbed after oral administration and diffuses into several tissues, including bones and articular cartilages. The active ingredient in the treatment of osteoarthritis is glucosamine. Data supports Glucosamine as the first anti-osteoarthritic drug that treats both sign and symptoms of osteoarthritis and modifies disease progression. It is as effective as NSAIDs with significantly better tolerability and clinical compliance. Indications Indicated for the treatment of osteoarthritis of knee, hip, spine, and other locations. As dietary supplement Dosage and Administration One (500 mg) tablet three times daily or as directed by the physicians. A single dose of 1500 mg daily may also be effective. Obese individuals may need higher doses, based on body weight. Contraindication There are no known contraindication for Glucosamine. But proven hypersensitivity to Glucosamine is a contraindication. Precautions Diabetics are advised to monitor blood glucose levels regularly while taking Glucosamine. No special studies were performed in patients with renal and/or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitations for

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these patients. However administration of Glucosamine to these patients with severe hepatic or renal insufficiency should be under appropriate medical supervision. Side Effects Safety studies with Glucosamine show no demonstrable toxicity. Rarely occurring side effects like mild and reversible intestinal flatulence are almost like placebo. Use in Pregnancy and Lactation Women who are pregnant or who could become pregnant should not supplement with glucosamine. Glucosamine has not been studied enough to determine their effects on a developing fetus. And no studies have evaluated the use of Glucosamine during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation. Drug Interactions There have been no reports of significant drug interactions of Glucosamine with antibiotics/antidepressants/antihypertensives/nitrates /antiarrythmics/anxiolytic/hypoglycaemic agents/anti-secretives. Commercial Pack Reflon Tablet : Each box contains 10 blister strips or 10 tablets. Each film coated tablet contains Glucosamine Hydrochloride USP equivalent to 500 mg Glucosamine.

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Relentus
Tablet

Description Tizanidine Hydrochloride is a centrally acting skeletal muscle relaxant. Each tablet contains Tizanidine Hydrochloride INN equivalent to 2 mg Tizanidine. Indications It is used in the symptomatic treatment of painful muscle spasm associated with musculoskeletal conditions and as an adjunct in the management of spasticity associated with multiple sclerosis or spinal cord disorders. Dosage and Administration The usual initial daily dose is 2 mg as a single dose. The daily dose may be increased thereafter according to response in steps of 2 mg at intervals of at least 3 to 4 days, usually up to 24 mg daily given in 3 to 4 divided doses. The maximum recommended dose is 36 mg daily. Contraindication Tizanidine Hydrochloride is contraindicated to the patients who have known hypersensitivity to this drug and in case of severe hepatic impairment. Precautions Patients with impaired kidney or liver function; when patients drive a vehicle or operate machinery. Side Effects Tizanidine Hydrochloride may cause drowsiness, fatigue, dizziness, dry mouth, nausea, gastrointestinal disturbances, hypotension. Bradycardia, insomnia, hallucinations and altered liver enzymes, and rarely acute hepatitis have also been reported. Drug Interactions Alcohol or other CNS depressants may enhance the CNS effects of Tizanidine. There may be an additive hypotensive effect when Tizanidine is used in patients receiving antihypertensive therapy. 323

Use in Children Experience in children is limited and the use of Tizanidine in this patient group is not recommended. Use in Elderly Renal clearance in the elderly may in some cases be significantly decreased. Caution is therefore indicated when using in elderly patients. Use in Pregnancy and Lactation Tizanidine has no teratogenic effects in rats and rabbits. As there have been no controlled studies in pregnant women, however, it should not be used during pregnancy unless the benefit clearly outweighs the risk. Although only small amounts of Tizanidine are excreted in animal milk, lactating women should not take Tizanidine. Commercial Pack Relentus Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Tizanidine Hydrochloride INN equivalent to 2 mg Tizanidine.

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Resitone
Tablet

Description Resitone is a combination of a potassium sparing diuretic, Spironolactone and a loop diuretic, Frusemide. This combination produces synergistic or additive diuretic effects. Frusemide component inhibits the + + Na /K /2Cl co-transporter in the ascending limb of Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions thereby increasing the quantity of sodium and the volume of water excreted in the urine. Spironolactone component inhibits the reabsorption of sodium and excretion of potassium at the distal tubule by blocking the action of aldosterone. So the excretion of sodium is increased and the excess loss of potassium, induced by Frusemide is decreased. Indications Resitone is indicated for the treatment of - Oedema - Congestive heart failure - Liver cirrhosis with ascites - Essential hypertension - Hyperaldosteronism Dosage and Administration 1 to 4 tablets daily (50 to 200 mg of Spironolactone and 20 to 80 mg of Frusemide) according to the patients response. Contraindication Resitone is contraindicated in patients with a history of hypersensitivity to Spironolactone or Frusemide. It is also contraindicated in acute renal insufficiency, anuria, and Hyperkalemia. Side Effects Fatigue, blood disorders, skin rashes, diarrhoea, constipation, nausea, vomiting, abdominal pain, hyperglycaemia, hypotension, gynaecomastia, irregular menstrual cycle, disturbances in the levels of electrolyte in the blood, and impotence may occur. 325

Precautions It is recommended that individuals taking this medicine have their fluid and electrolyte balance monitored regularly. Resitone should be used with caution in diabetes, enlarged prostate, hypotension and hypovolaemia. Use in Pregnancy and Lactation Resitone should be used with caution during pregnancy and only if expected benefit to mother is greater than the possible risk to the foetus. It is recommended that mothers should avoid using this medicine while breast feeding. Drug Interactions When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalaemia. Spironolactone increases the levels of cardiac glycosides such as Digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalaemia if they are used with Spironolactone. When taken together with drugs that decrease blood pressure there is an increased risk of significant lowering of blood pressure and may cause fainting, especially when given with the first dose of ACE inhibitors (e.g. Captopril). The blood pressure lowering and diuretic effects of Frusemide may be reduced or abolished when used together with Indomethacin and possibly other non-steroidal antiinflammatory drugs (NSAIDs). Pharmaceutical Precaution Store between 15 C to 25 C. Keep in a cool dry place. Keep out of the reach of children Commercial Pack Resitone Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Spironolactone BP 50 mg and Frusemide BP 20 mg.

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Reumafen
Tablet/Suspension

Description Reumafen (Ibuprofen) is chemically ()-2-(p-isobutylphenyl) propionic acid. It is a non-steroidal anti-inflammatory agent with analgesic and antipyretic properties. After oral administration, Ibuprofen is rapidly and almost completely absorbed. Peak serum levels are achieved between 1 and 2 hours after dosing. Ibuprofen is excreted in the urine and excretion is completed within 24 hour. Indications Reumafen is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathies non-articular rheumatic conditions such as frozen shoulder, bursitis, tendinitis, tenosynovitis and low back pain soft tissue injuries such as sprain, strain and post-operative pain dysmenorrhoea dental pain cold and fever Dosage and Administration For children 20 mg per kg body weight daily in divided doses. In children weighing less than 30 kg the total daily dosage should not exceed 500 mg. If gastrointestinal disturbances occur Reumafen should be given with food or milk. 1-2 years : tea spoonful (2.5 ml) 3-4 times daily; 3-7 years : 1 tea spoonful (5 ml) 3-4 times daily; 8-12 years : 2 tea spoonful (10 ml) 34 times daily. For adult For arthritic pain : The dosage range is from 0.9 to 2.4 g per day. The usual dose is 400 mg, 3-4 times per day, preferably after food. 327

The dose may be raised to a maximum of 2.4 g daily depending on the severity of symptom at the time of initiating drug therapy or as patients fail to respond. After a satisfactory response has been achieved the dose should be reviewed and adjusted as required and tapered gradually. For mild to moderate pain : 400 mg 6 hourly or as demanded by the condition. For dysmenorrhoea : 400 mg every 4 hours or as demanded by the condition. Contraindication Reumafen should not be given to patients with hypersensitivity to lbuprofen and to individuals who show nasal polyps, angioedema, bronchospastic reactivity to Aspirin or other non-steroidal antiinflammatory drug. Precautions Reumafen should be given with caution to patients with bleeding disorders, cardiovascular diseases, peptic ulceration or a history of such ulceration and in those who are receiving coumarin anticoagulants and in patients with renal or hepatic impairment. Use in Pregnancy and Lactation Reumafen is not recommended during pregnancy or for use in nursing mothers. Side Effects Usually Reumafen has a low incidence of side effects. The most frequent side effects are gastrointestinal disturbances. Peptic ulceration and gastrointestinal bleeding have occasionally been reported. Other side effects include headache, dizziness, nervousness, skin rash, pruritus, drowsiness, insomnia, blurred vision and other ocular reactions, hypersensitivity reaction, abnormal liver function test, impairment of renal function, agranulocytosis and thrombocytopenia. Overdosage Gastric lavage, correction of blood electrolyte (if necessary). There is no specific antidote for Ibuprofen.

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Pharmaceutical Precaution Keep in a cool and dry place. Keep out of the reach of children. Commercial Pack Reumafen-200 Tablet : Box containing 100 sugar coated tablets in 10 x 10's blister strips, each tablet contains Ibuprofen BP 200 mg. Reumafen-400 Tablet : Box containing 100 sugar coated tablets in 10 x 10's blister strips, each tablet contains Ibuprofen BP 400 mg. Reumafen Suspension : 100 ml suspension in amber glass bottle. Each 5 ml contains Ibuprofen BP 100 mg.

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Rolacin
Tablet

Description Rolacin (Clarithromycin) is a semisynthetic antibiotic of macrolide group, available as 250 mg and 500 mg film coated tablet. It binds to the 50S ribosomal subunit of susceptible bacteria and suppresses its protein synthesis. Rolacin is highly effective against a wide range of aerobic and anaerobic Gram-positive and Gram-negative bacteria. The active ingredient of Rolacin is Clarithromycin USP. Indications Rolacin (Clarithromycin) is indicated for the treatment of mild to moderate infections caused by susceptible strains of the microorganisms listed below Upper respiratory tract infections : pharyngitis and tonsillitis due to Streptococcus pyogenes, Acute maxillary sinusitis due to Streptococcus pneumoniae

Lower respiratory tract infections : pneumonia due to Mycoplasma pneumoniae or Streptococcus pneumoniae, Acute exacerbation of chronic bronchitis Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes Acute otitis media As an adjunct in the treatment of duodenal ulcers for the eradication of H. pylori.

Dosage and Administration Adult : Recommended dosage in adults is 250 mg every 12 hours for 7 days. In severe cases, dosage may be increased up to 500 mg every 12 hours for up to 14 days. In patients with renal impairment with creatinine clearance <30 ml/ min, the dosage should be reduced by half. 330

Eradication of H. pylori : Rolacin-500 (Clarithromycin) 1 Tablet twice daily Proceptin-20 (Omeprazole) 1 Capsule twice daily Filmet-400 (Metronidazole) 1 Tablet twice daily (For 7-day treatment regimen) Dosage schedule of Children :Body weight under 8 kg : 8-11 kg (1 to 2 years) : 12-19 kg (3 to 6 years) : 20-29 kg (7 to 9 years) : Children older than 10 years :

7.5 mg/kg twice daily 62.5 mg twice daily 125 mg twice daily 187.5 mg twice daily 250 mg twice daily

The usual duration of treatment is 7 to 14 days depending on the pathogen involved and the severity of infection. Contraindication It is contraindicated in patients with known hypersensitivity to Clarithromycin or any other macrolide antibiotics. Side Effects Rolacin is generally well tolerated. Commonly reported side effects include nausea, vomiting, diarrhoea, abdominal pain, stomatitis and glossitis. Other side effects include allergic reactions and headache. Precautions Clarithromycin is principally excreted by the liver and kidney. Caution should be exercised in administering this antibiotic to patients with impaired hepatic and renal functions. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy instituted. Concomitant administration with Theophylline has been associated with increased serum Theophylline level. Effects of Digoxin and Warfarin may be potentiated with concomitant administration of Clarithromycin. Drug Interactions Clarithromycin should not be prescribed with Terfenadine and Cisapride. 331

Commercial Pack Rolacin Tablet : Box containing 20 tablets in 2 x 10s blister strips. Each film coated tablet contains Clarithromycin USP 250 mg. Rolacin-500 Tablet : Box containing 10 tablets in 1 x 10s blister strip. Each film coated tablet contains Clarithromycin USP 500 mg.

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Rostil
Tablet

Description Rostil is a musculotropic antispasmodic agent available as film coated tablet, each containing 135 mg of Mebeverine Hydrochloride BP. It acts directly on smooth muscle of gastrointestinal tract and is used to treat bowel spasm. Indications Rostil is indicated :

for the symptomatic relief of irritable bowel syndrome other conditions include; - Chronic irritable colon - Spastic constipation - Mucous colitis - Colicky abdominal pain and cramps - Persistent non-specific diarrhoea

Dosage and Administration Adults (including elderly) : One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced. Side Effects There are no known life-threatening toxic effects of Rostil. There are few reported cases of overdose with Mebeverine. Contraindication None known. Use in Special Population Neonates : Not recommended for neonates. Children : The preparation is only recommended for children over 10 years. 333

Pregnant woman : No teratogenicity has been shown in animal experiments and there are no known teratogenic effects in human. Drug Interactions None known. Overdosage On theoretical grounds it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended. Commercial Pack Rostil Tablet : Box containing 5 blister strips of 10 tablets, each tablet contains Mebeverine Hydrochloride BP 135 mg.

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Sensipin
Tablet

Description Sensipin tablet contains Clozapine BP 25 mg, which is an atypical neuroleptic and a dibenzodiazepine. Indications Sensipin is indicated for- Refractory psychoses, psychotic patients with severe extrapyramidal symptoms with other treatments, and psychotic patients with severe tardive dyskinesia with other treatments. Dosage and Administration To minimize the incidence of adverse effects, Sensipin should be introduced gradually, beginning with low doses and increasing according to response. Initial Treatment : It is recommended that treatment with Sensipin should begin with one-half of a 25 mg tablet (12.5 mg) once or twice daily and then be continued with daily dosage increments of 25-50 mg/day, if welltolerated, to achieve a target dose of 300-450 mg/day by the end of two weeks. Subsequent dosage increments should be made not more than once or twice weekly, in increments not to exceed 100 mg. Most patients are expected to respond to 200-450 mg daily, a larger proportion may be given at night. Maintenance dose : Once a therapeutic response has been obtained, a gradual reduction of dosage to a maintenance dose of 150 to 300 mg daily may be made. Daily maintenance doses of 200 mg or less may be given as a single dose in the evening. Where possible, Sensipin should be withdrawn gradually over a 1-2 week period. Discontinuation of treatment : In the event of planned termination of Sensipin therapy, gradual reduction in dose is recommended over a 1-2 week period. However, if a patients medical condition requires abrupt discontinuation (e.g. Leucopenia), the patient should be carefully observed for the recurrence of psychotic symptoms. 335

Contraindication Sensipin is contraindicated in patients with myeloproliferative disorders, uncontrolled epilepsy, or with a history of Clozapine induced agranulocytosis or severe granulocytopenia. As with more typical antipsychotic drugs, Sensipin is contraindicated in severe central nervous system (CNS) depression or comatose states from any causes. Sensipin should not be used simultaneously with other agents having a well-known potential to cause agranulocytosis or otherwise suppress bone marrow function. The mechanism of Clozapine induced agranulocytosis is unknown; nonetheless, it is possible that causative factors may interact synergistically to increase the risk and/or severity of bone marrow suppression. Side Effects Potentially life-threatening effects : Clozapine can cause reversible neutropenia which may progress to a potentially fatal agranulocytosis; the greatest risk is from the second to the sixth month of treatment. All patients undergoing treatment should have weekly differential white cell counts. Agranulocytosis is reversible on drug withdrawal but potentially fatal if unheeded or undetected. Acute overdosage : No case of this kind has been reported. Severe or irreversible adverse effects : Toxic delirium can occur in about 3% of patients. Symptomatic adverse effects : Sedation and syncope from hypotension may occur especially at the start of treatment. The drug has been reported to cause influenza like syndrome. Extrapyramidal disorders including tardive dyskinesia appear to be rare or absent with Sensipin. Sensipin has little effect on prolactin secretion; endocrine and sexual dysfunction are uncommon. Overdosage Human experience : The most commonly reported signs and symptoms associated with Clozapine overdoses are altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. Management of overdosage : Establish and maintain airways; ensure adequate

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oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. There are no specific antidotes for Clozapine. Forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit. In managing overdosage, the physician should consider the possibility of multiple drug involvement. Precautions General : Because of the significant risk of agranulocytosis and seizure, the extended treatment failing to show an acceptable level of clinical response should ordinarily be avoided. In addition, the need for continuing treatment in patients exhibiting beneficial clinical responses should be periodically re-evaluated. Fever : During Clozapine therapy, patients may experience transient temperature elevations above 100.4F with the peak incidence within the first 3 weeks of treatment. On occasion, there may be an associated increase or decrease in WBC count. Patients with fever should be carefully evaluated to rule out the possibility of an underlying infectious process or the development of agranulocytosis. In presence of high fever, the possibility of Neuroleptic Malignant Syndrome (NMS) must be considered. Anticholinergic toxicity : Clozapine has very potent anticholinergic effects and great care should be exercised in using this drug in presence of prostatic enlargement or narrow angle glaucoma. In addition, Clozapine use has been associated with varying degrees of impairment of intestinal peristalsis, ranging from constipation to intestinal obstruction, faecal impaction and paralytic ileus. Interference with cognitive and motor performance : Because of initial sedation, Clozapine may impair mental and/or physical abilities, especially during the first few days of therapy. The recommendations for gradual dose escalation should be carefully adhered to, and patients be cautioned about activities requiring alertness.

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Use in patients with concomitant illness : Clinical experience with Clozapine in patients with concomitant systemic diseases is limited. Nevertheless, caution is advisable in using Clozapine in patients with hepatic, renal or cardiac disease. Use in patients undergoing general anaesthesia : Caution is advised in patients being administered general anaesthesia because of the CNS effects of Clozapine. Checking with the anaesthesiologist is required regarding continuation of Clozapine therapy in a patient scheduled for surgery. Drug Interactions The risk of using Clozapine in combination with other drugs has not been systematically evaluated. The mechanism of Clozapine induced agranulocytosis is unknown; nonetheless, the possibility that causative factors may interact synergistically to increase the risk and/or severity of bone marrow suppression warrants consideration. Therefore, Clozapine should not be used with other agents having a well-known potential to suppress bone marrow function. Given the primary CNS effects of Clozapine, caution is advised in using it concomitantly with other CNS active drugs or alcohol. Orthostatic hypotension in patients taking Clozapine can, in rare cases, be accompanied by profound collapse and respiratory and/or cardiac arrest. Although it has not been established that there is an interaction between Clozapine and benzodiazepines or other psychotropics, caution is advised when Clozapine is initiated in patients taking a benzodiazepine or any other psychotropic drug. Commercial Pack Sensipin Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Clozapine BP 25 mg.

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Serelose
Solution

Deascription Serelose is a brand of Lactulose, a hyperosmolar laxative- an effective treatment approach for constipation. It is a non-absorbable disaccharide which draws water into the bowel; causes distention through fluid accumulation, thus promotes soft stool and accelerates bowel motion. What is Constipation? Constipation is a common problem with a variety of possible causes. This term may be used to describe several different symptoms. The normal frequency of stool passage is from three times a day to once in every three days. Going more than three days without a bowel movement is therefore considered abnormal. Some people feel miserable if they do not defaecate on a daily basis. Others may go a week or longer without any ill effects. Hard stool, straining to pass, or a sense of incomplete evacuation may also be termed constipation. Constipation may worsen with time because of the disease process. If a person feels uncomfortable as a result of bowel problems then treatment is justified to relieve or minimize these symptoms. Indications Constipation Hepatic encephalopathy Dosage and Administration Adults (including elderly) : 3 tea spoonful or 15 ml twice daily Children 5 to 10 years : 2 tea spoonful or 10 ml twice daily Children under 5 years Babies under 1 year : 1 tea spoonful or 5 ml twice daily : tea spoonful or 2.5 ml twice daily (paediatric dose should be given after breakfast)

Each dose of Serelose may, if necessary, be taken with water or fruit juices, usually once a day, preferably in the morning. If a dose is forgotten 339

it should be taken as soon as one remembers up to 8 hours before bedtime. If later, wait for next scheduled dose (dont double this dose). Dont take at bedtime. Usual time lapse before drug works is 30 minutes to 3 hours. Overdosage Symptoms of overdosage include fluid depletion, weakness, vomiting, fainting etc. Overdosage is unlikely to threaten life. If one takes much larger amount than prescribed, consultation with physician is essential. Side Effects Life threatening : None expected; Common : Increased thirst, cramps, nausea, diarrhoea, flatulence; Infrequent : Irregular heart beat, muscle cramps; Rare : Dizziness, confusion, fatigue, weakness. Safety Serelose is safe in the long term and has been used effectively even in frail elderly patients. Precautions It should be avoided if one is allergic to any hyperosmotic laxative, have symptoms of appendicitis, inflammatory bowel diseases or intestinal blockage, have missed a bowel movement for only 1 or 2 days. Adverse reactions over age 60 year may be more frequent and severe than in younger persons. In pregnancy no proven problems were detected. Avoid the drug if possible. Consultation with physician is required. It has no side effect during breast feeding. Lactulose oral solution could be used in infants and children only under medical supervision. It should not be used to flush out the system or as a tonic'. Commercial pack Serelose Solution : Each amber glass bottle contains 100 ml Serelose solution. Each 5 ml contains Lactulose solution BP equivalent to 3.35 g Lactulose.

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Sibulin
Capsule

Description Sibulin is an orally administered agent for the treatment of obesity. Each capsule contains 5 mg of Sibutramine Hydrochloride Monohydrate INN. Indications Sibulin is indicated for the management of obesity including weight loss and maintenance of weight loss and should be used in conjunction with a reduced calorie diet. Sibulin is recommended for obese patients with an initial body mass index 30 kg/m2 or 27 kg/m2 in the presence of other risk factors (e.g. hypertension, diabetes, dyslipidaemia). [Metric conversion are as follows : 2.2 pounds = 1 kg and inches x 2.54 = meter.] Dosage and Administration The recommended starting dose of Sibulin is 10 mg administered once daily with or without food. If there is inadequate weight loss the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Contraindication Sibulin is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs) antidepressants, with hypersensitivity to Sibutramine or any of the ingredients of Sibulin, who have anorexia nervosa, and in those taking other centrally acting appetite suppressant drugs. Side Effects In placebo-controlled obesity studies the most common events were dry mouth, anorexia, insomnia and constipation. Use in Special Population Paediatric : The safety and effectiveness of Sibulin in paediatric patients under 16 years old has not been established. Renal Insufficiency : Sibulin should not be used in patients with severe renal impairment.

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Hepatic Insufficiency : Dosage adjustment in patients with mild to moderate hepatic impairment is not required. Sibulin should not be used in patients with severe hepatic dysfunction. Use in Pregnancy and Lactation The use of Sibulin during pregnancy is not recommended. Women of child-bearing potential should employ adequate contraception while taking Sibulin. It is not known whether Sibutramine or its metabolites are excreted in human milk. Sibulin is not recommended for use in nursing mothers. Drug Interactions Because Sibulin inhibits serotonin reuptake it should not be administered with other serotonergic agents such as Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and Venlafaxine. Because Sibulin inhibits serotonin reuptake, Sibulin should not be used concomitantly with monoamine oxidase inhibitors MAOIs e.g. Phenelzine and Selegiline. At least 2 weeks should elapse between discontinuation of a MAOI and initiation of treatment with Sibulin. Similarly at least 2 weeks should elapse between discontinuation of Sibulin and initiation of treatment with MAOI. The rare but serious constellation of symptoms termed serotonin syndrome has also been reported with the concomitant use of two serotonin reuptake inhibitors. Warning Sibulin substantially increases blood pressure in some patients. Regular monitoring of blood pressure is required when prescribing Sibulin. Sibulin should not be used in patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Because Sibulin can cause mydriasis, it should be used with caution in patients with narrow angle glaucoma. Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Sibulin. Overdosage There is no specific antidote to Sibulin. Treatment should consist of general measures employed in the management of overdosage, an airway should be established, cardiac and vital sign monitoring is recommended;

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general symptomatic and supportive measures should be instituted. Cautious use of -blockers may be indicated to control elevated blood pressure or tachycardia. Pharmaceutical Precaution Store at temperature between 15o C and 30oC. Commercial Pack Sibulin Capsule : Box containing 60 capsules in 6 x 10s blister strips. Each capsule contains Sibutramine Hydrochloride Monohydrate INN 5 mg.

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Spanil
Tablet

Description Spanil is an antispasmodic containing in each tablet 10 mg of Hyoscine Butylbromide BP. Hyoscine Butylbromide is a competitive antagonist of acetylcholine at postganglionic parasympathetic nerve endings. It relaxes smooth muscles of the hollow organs of the abdominal and pelvic cavities. Indications It is indicated for the following conditions :

Spasm of the gastrointestinal tract Spasm of the genito-urinary tract Spasmodic dysmenorrhoea

Dosage and Administration Adult : 1-2 tablets 3-4 times daily Children (6-12 years) : 1 tablet 3 times daily Contraindication Spanil should not be given to patients suffering from glaucoma. Precautions Should be used with caution during 1st trimester of pregnancy. Side Effects Dryness of mouth and tachycardia have been reported infrequently during treatment with Hyoscine Butylbromide. Commercial Pack Spanil Tablet : Box containing 10 blister strips of 10 film coated tablets, each tablet contains 10 mg of Hyoscine Butylbromide BP.

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Sparlin
Tablet

Description Sparlin (Sparfloxacin) is a synthetic, broad-spectrum antibacterial agent from the fluoroquinolone family. It has been reported to be more active in vitro than other fluoroquinolones against some Gram-positive organisms (such as Streptococcus pneumoniae and Staphylococcus aureus), Mycobacteria and Chlamydia spp. Each Sparlin tablet contains Sparfloxacin INN 200 mg. Indications Sparlin is indicated for the treatment of the following infections due to susceptible microorganisms:

Upper and lower respiratory tract infections including sinusitis, acute exacerbation of chronic bronchitis, community and hospital acquired pneumonia. Urinary tract infections including gonococcal and non-gonococcal urethritis, chancroid and other sexually transmitted diseases. Skin and soft tissue infections. Prophylactic use in different urological and ophthalmic operations.

Dosage and Administration The recommended daily adult dose is two tablets (400 mg) on first day as a loading dose, followed by one tablet (200 mg) daily as a maintenance dose. Duration of maintenance treatment is 5 to 10 days. It can be taken with or without food. Use in Children, Pregnancy and Lactation It is not recommended for children below 12 years of age. Sparfloxacin should be administered in pregnant women and lactating mother only if the potential maternal benefits justify the risks to the foetus/neonate.

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Contraindication Hypersensitivity to fluoroquinolones including Sparfloxacin. It is also contraindicated in patients with known QTc prolongation or in those with pre-arrhythmic conditions (e.g., hypokalaemia, significant bradycardia, congestive heart failure, atrial fibrillation or other cardiac disease). Precautions Renal disease, gastric ulcers, concomitant use of NSAIDs. In renal failure of third degree severity (creatinine clearance <30 ml/min) dosage modification is recommended- 400 mg on 1st day, 200 mg on 2nd and 3rd day followed by 200 mg every 48 hours. Because fluoroquinolones have been associated with tendon rupture, Sparfloxacin should be discontinued at the first sign of tendon pain. Exposure to UV radiation during treatment should be avoided. Side Effects Side effects are mild, transient and seldom. These are allergic reactions; photosensitization; gastrointestinal disorders including nausea, vomiting, diarrhoea; headache and sleep disturbance at the start of treatment. Drug Interactions On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole, Terfenadine, vinca alkaloids there is increased risk of arrhythmia. Salts, oxides and hydroxides of Magnesium, Aluminium and Calcium decrease absorption of Sparfloxacin. Commercial Pack Sparlin Tablet : Box containing 1 blister strip of 10 tablets, each tablet contains Sparfloxacin INN 200 mg.

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Spulyt
Tablet/Syrup

Description Spulyt (Bromhexine Hydrochloride) is a highly effective expectorant. Indications Spulyt is indicated in the treatment of respiratory disorders associated with productive cough. These include; tracheobronchitis, bronchitis with emphysema, bronchiectasis, bronchitis with bronchospasm, chronic inflammatory pulmonary conditions and pneumoconiosis. Dosage and Administration Spulyt tablet Adults and Children over 10 years

: 8-16 mg 3 times daily.

Spulyt syrup Adults: The recommended daily dose is 2 to 4 tea spoonfuls 3 times. Initially 4 tea spoonfuls 3 times daily and then as required. Children: Suggested dosage for children under 2 years is tea spoonful 3 times daily, for 2-5 years is tea spoonful 3 times daily and for children aged 5-10 years 1 tea spoonful 3 times daily. Side Effects Gastrointestinal side effects may occur occasionally with Bromhexine Hydrochloride, and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, dizziness, sweating and skin rash. Precautions Since Bromhexine Hydrochloride may disrupt the gastric mucosa so Bromhexine Hydrochloride should be used with care in patients with a history of peptic ulceration. Care is also advisable in asthmatic patients. Contraindication Contraindicated to those who are hypersensitive to Bromhexine Hydrochloride. 347

Pharmaceutical Precaution Store below 25C. Protect from light. Keep the container tightly closed. Commercial Pack Spulyt Tablet : Each box contains 10 blister strips of 10 tablets. Each tablet contains Bromhexine Hydrochloride BP 8 mg. Spulyt Syrup : Bottle containing 100 ml syrup. Each 5 ml contains Bromhexine Hydrochloride BP 4 mg.

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Tamona
Tablet

Description Tamona (Tamoxifen) is a non-steroidal, triphenylene-based drug which displays a complex spectrum of oestrogen antagonist and oestrogen agonist-like pharmacological effects in different tissues. In breast cancer patients, at the tumour level, Tamoxifen acts primarily as an antioestrogen, preventing oestrogen binding to the oestrogen receptor. Additionally Tamoxifen has been reported to lead to maintenance of bone mineral density in postmenopausal women of the order of 10-20%. Additionally Tamoxifen has been reported to lead to maintenance of bone mineral density in postmenopausal women. Pharmacology After oral administration, Tamona (Tamoxifen) is absorbed rapidly with maximum serum concentrations attained within 4-7 hours. Steady state concentrations (about 300 mg/ml) are achieved after four weeks treatment with 40 mg daily. The drug is highly protein bound to serum albumin (99%). Metabolism is by hydroxylation, demethylation and conjugation, giving rise to several metabolites which have a similar pharmacological profile to the parent compound and thus contribute to the therapeutic effect. Excretion occurs primarily via the faeces and an elimination half-life of approximately seven days has been calculated for the drug itself, whereas that for N-desmethyltamoxifen, the principal circulating metabolite, is 14 days. Indications Tamona is indicated for the treatment of breast cancer. Dosage and Administration Adults (including elderly): The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily. Contraindication Tamona must not be administered during pregnancy. Tamona should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. 349

Side Effects Side effects can be classified as either due to the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae and tumour flare or as more general side effects, e.g. gastrointestinal intolerance, headache, light-headedness and occasionally fluid retention and alopecia. When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease. Skin rashes including isolated reports of erythema multiforme, StevensJohnson syndrome and bullous pemphigoid and rare hypersensitivity reactions, including angioedema have been reported. A small number of patients with bony metastases have developed hypercalcaemia on initiation of therapy. Falls in platelet count, usually only to 80,000-90,000 per/mm3 but occasionally lower, have been reported in patients taking Tamona for breast cancer. A number of cases of visual disturbances including infrequent reports of corneal changes and retinopathy have been described in patients receiving Tamoxifen therapy. An increased incidence of cataracts has been reported in association with the administration of the drug. Uterine fibroids and endometrial changes including hyperplasia and polyps have been reported. Cystic ovarian swellings have occasionally been observed in premenopausal women receiving Tamoxifen. Leucopenia has been observed following the administration of Tamoxifen, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions; this can sometimes be severe. There is evidence of an increased incidence of thromboembolic events including deep vein thrombosis and pulmonary embolism during Tamoxifen therapy. Tamoxifen has been associated with changes in liver enzyme levels and on rare occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis.

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Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Tamoxifen. Overdosage On theoretical grounds, overdosage would be expected to cause enhancement of the pharmacological effects mentioned above. Observations in animals show that extreme overdosage (100-200 times recommended daily dose) may produce oestrogenic effects. There is no specific antidote to overdosage and treatment must be symptomatic. Precautions Menstruation is suppressed in a proportion of premenopausal women receiving Tamoxifen for the treatment of breast cancer. An increased incidence of endometrial cancer has seen reported in association with Tamoxifen treatment. The underlying mechanism is unknown, but may be related to the oestrogen-like effect of Tamona. Any patients receiving or having previously received Tamona, who report abnormal gynecological symptoms, especially vaginal bleeding, should be promptly investigated. A number of second primary tumors, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with Tamoxifen. No causal link has been established and the clinical significance of these observations remains unclear. Drug Interactions When Tamoxifen is used in combination with coumarin type anticoagulants, a significant increase in anticoagulant effect may occur. Where such co-administration is initiated, careful monitoring of the patient is recommended. When Tamoxifen is used in combination with cytotoxic agents, there is an increased risk of thromboembolic events. Use in Pregnancy and Lactation Tamoxifen must not be administered during pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and foetal deaths after women have taken Tamoxifen, although no causal relationship has been established. Reproductive toxicology studies in rats, rabbits and monkeys have shown no teratogenic potential. 351

Women should be advised not to become pregnant whilst taking Tamona and should use barrier or other nonhormonal contraceptive methods if sexually active. Premenopausal patients must be carefully examined before treatment to exclude pregnancy. Women should be informed of the potential risks to the foetus, if they want to become pregnant whilst taking Tamona or within two months of cessation of therapy. It is not known if Tamoxifen is excreted in human milk and therefore the drug is not recommended during lactation. The decision to discontinue Tamona should take into account in case of the importance of the drug to the lactating mother. Commercial Pack Tamona 10 Tablet: Box containing 30 tablets in 3 x 10s Alu-Alu form packs. Each tablet contains Tamoxifen Citrate BP equivalent to 10 mg of Tamoxifen. Tamona 20 Tablet : Box containing 30 tablets in 3 x 10s Alu. Alu. form packs. Each tablet contains Tamoxifen Citrate BP equivalent to 20 mg of Tamoxifen.

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Taverin
Tablet

Description Each tablet contains Drotaverine Hydrochloride INN 40 mg. Taverin is a potent synthetic antispasmodic which is readily absorbed from the intestine. Like papaverine, it acts directly on the smooth muscle fibers, exceeding however, the antispasmodic effect of the standard preparations. Taverin is characterized by a rapid onset of actions which is very advantageous in cases of acute painful spastic conditions. In addition to its spasmolytic and vasodilatory actions, Taverin elicits a selective blockade of cardiac -receptors. Indications Taverin is indicated in the following indications : i) Spastic conditions of the gastrointestinal tract: irritable bowel syndrome, tensmus in dysentery; biliary colics and spastic conditions of the biliary tract such as cholecystolithiasis, cholecystitis, cholangitis; ii) Renal colics and spastic conditions of the urogenital tract: nephrolithiasis, ureterolithiasis, pyelitis, cystitis; iii) Spastic conditions of the uterus: dysmenorrhoea, imminent abortion, uterine tetanus. Owing to its freedom from cardiotoxic and hypotensive effects as well as its specificity of cardiac adrenolytic action. For this reason Taverin is of outstanding value in the treatment of coronary insufficiency and angina pectoris. Dosage and Administration The average dose for adults is daily three-times 1 to 2 tablets. Children should be given smaller doses according to age and body weight. Small children should receive once or twice daily - tablet, older children to 1 tablet daily. In peptic ulcer it is expedient to combine Taverin with atropine or atropine-like compounds. Contraindication Hypersensivity to Drotaverine or any of the components of Taverin.

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Side Effects The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, pharyngitis, oedema and fatigue. Use in Pregnancy and Lactation As with most drugs, the use of Drotaverine Hydrochloride should be avoided during pregnancy and lactation unless essential. Pharmaceutical Precaution Should be kept away from moisture and heat and out of the reach of children. Commercial Pack Taverin Tablet: Box containing 100 tablets in 10 x 10s blister strips. Each tablet contains Drotaverine Hydrochloride INN 40 mg.

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Terbex
Cream/Tablet

Description Terbex is a preparation of Terbinafine Hydrochloride. Terbinafine is an allylamine with a range of antifungal activity. It is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Terbinafine is either fungicidal or fungistatic against yeasts, depending on the species. Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the fungal cell membrane at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine is highly effective in fungal infections of the skin, hair and nails caused by Trichophyton spp., Microsporum spp. and Epidermophyton floccosum. It is also effective against yeast infections of the skin, principally those caused by the genus candida. Topical terbinafine appears to be effective in pityriasis versicolor due to Pityrosporum arbiculare. Indications Terbex cream is indicated for the treatment of the following dermatological infections : interdigital tenia pedis (Athletes foot), tenia cruris (jock itch) or tenia corporis (ring worm) due to susceptible organisms and planter tenia pedis (mocasin type) due to Trichophyton spp. Terbex tablet is indicated for the treatment of onychomycosis of the toe nail or finger nail due to dermatophytes and also by non-dermatophyte fungi. Dosage, Application and Administration Topical application of Terbex cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Terbex tablet therapy. Usual duration of treatment of Terbex cream in Tinea corporis and Tinea cruris : 1-2 weeks. In Tinea pedis : 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.). In Cutaneous candidiasis : 1-2 weeks and in Pityriasis (tinea) versicolor : 2 weeks. 355

To prevent relapses in fungal infection, treatment should be continued for a adequate length of time. To apply Terbex cream clean and dry the affected areas thoroughly and apply the cream once or twice a day to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections the application may be covered with a gauze strip, especially at night. Oral administration of Terbex tablet is essential for hair or nail infections. The usual oral dose is 1 Terbex tablet (250 mg) daily for 2 to 12 weeks depending upon the infection. Finger nail onychomycosis : 1 Terbex tablet (250 mg) once daily for 6 weeks. Toe nail onychomycosis : 1 Terbex tablet (250 mg) once daily for 12 weeks. Use in Children Experience with topical Terbex in children is limited and its use cannot therefore be recommended. Contraindication Hypersensitivity to Terbinafine or any of the excipients in the preparation. Side Effects In general, the side effects are mild, transient and do not lead to discontinuation of therapy. The side effects reported include gastrointestinal disturbances (diarrhoea, dyspepsia, and abdominal pain), rashes etc. Rarely, cases of symptomatic hepatobiliary dysfunction including cholestatic hepatitis have been reported. Besides, there have been isolated reports of serious skin reactions. If progressive skin rash occurs, treatment should be discontinued. Commercial Pack Terbex Cream : Tubes containing 5 g Terbinafine Hydrochloride INN 10 mg.

cream, each gram contains

Terbex Tablet : Box containing 1 blister strip of 10 tablets, each tablet contains Terbinafine Hydrochloride INN equivalent to 250 mg Terbinafine.

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Tofen
Tablet/Syrup

Description Tofen is a preparation of Ketotifen, which has antiallergic properties and has been used similarly, to Sodium Chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Tofen possesses marked anti-anaphylactic properties and is effective in preventing asthmatic attack. Tofen exerts sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its antianaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as administered by inhalation as a selective mast cell stabilizer. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Tofen may take several weeks to become fully established. Tofen will not abort established attacks of asthma. Indications Prophylactic treatment of bronchial asthma. Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis. Dosage and Administration Adults : 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases. Children above 2 (two) years : 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician. Use in elderly : Same as adult dose or as advised by the physician. Contraindication A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has 357

been suggested that this combination should therefore be avoided. Use in Pregnancy and Lactation Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breastfeeding can not be given. Precautions It is important to continue the previous treatment for a minimum of two weeks after starting Tofen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If intercurrent infection occurs, Tofen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Tofen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Tofen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. Tofen may potentiate the effects of sedatives, hypnotic, antihistamines and alcohol. Overdosage The reported features of overdosage include confusion, drowsiness, nystagmus, headache and disorientation. Bradycardia and respiratory depression should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise general supportive treatment shall be instituted. Side Effects Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days. Pharmaceutical Precaution Tofen tablet should be protected from heat and moisture. Commercial Pack Tofen Tablet : Box containing 10 blister strips of 10 tablets, each tablet contains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen. Tofen Syrup : 100 ml syrup in amber glass bottle, each 5 ml contains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen. 358

Triocim
Capsule/Suspension

Description Triocim (Cefixime) is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysis by many -lactamases. Triocim kills bacteria by interfering in the synthesis of the bacterial cell wall. 40-50% of an oral dose is absorbed from gastrointestinal tract, whether taken with meals or not. The plasma half life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. Triocim is mainly excreted unchanged in bile and urine. Indications Upper and lower respiratory tract infections Urinary tract infections Gonococcal urethritis Acute otitis media Dosage and Administration Adult dose : 1 or 2 capsule as a single dose or in two divided doses daily for 7 to 14 days, according to the severity of infection. Child dose : 8 mg/kg daily as a single dose or in two divided doses for 7 to 14 days according to the severity of infection age of the children. -1 year 1-4 year 5 -10 year Above 10 year : : : : 3.75 ml or 75 mg 5 ml or 100 mg 10 ml or 200 mg Adult dose

Side Effects Triocim is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature. Among them diarrhoea, changes in the colour of stool, nausea, abdominal pain, dyspepsia, headache, dizziness, elevation of serum amylase may occur.

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Contraindication Patients with known hypersensitivity to cephalosporin group of drugs. Precautions Triocim should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure. In pregnancy no data are available, so it is probably best to avoid using the drug during pregnancy and by the nursing mothers. Drug Interactions No data are available. Commercial Pack Triocim Capsule : Box containing 3 x 4s capsule in strip. Each capsule contains Cefixime Trithydrate USP equivalent to Cefixime 200 mg. Triocim Suspension : Bottle containing dry powder for preparation of 50 ml suspension. After reconstitution, each 5 ml contains Cefixime Trithydrate USP equivalent to Cefixime 100 mg.

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Triovix
Tablet

Description Each Triovix tablet contains Lamivudine INN 150 mg, Zidovudine USP 300 mg and Nevirapine INN 200 mg. A fixed dose combination of Lamivudine, Zidovudine and Nevirapine is recommended for Human Immunodeficiency Virus-1 (HIV-1) infected patients who are able to tolerate standard doses of Lamivudine, Zidovudine and Nevirapine for at least 2 weeks prior to switching over to this fixed dose combination. Patients should have demonstrated adequate tolerability to Nevirapine. Indications A fixed dose combination of Lamivudine, Zidovudine and Nevirapine is recommended for HIV-1 infected patients who are able to tolerate maintenance therapy with Nevirapine 200 mg twice daily. All three drugs are to be administered twice daily and each tablet contains half of the daily dose for each component. Twice daily formulation in single tablet for three drugs is convenient for patients to take, ensuring higher rate of compliance. Dosage and Administration For treatment of HIV Infection. Adult dosage : One tablet twice daily. This fixed dose combination is not recommended for patients who have not been on initial lower dose of Nevirapine 200 mg once daily for 2 weeks and or have not tolerated this dose. After successful therapy with low dose Nevirapine for two weeks, patients can be switched over to 200 mg bid dose provided they have not demonstrated any hypersensitivity reaction (rash, abnormal liver function tests) during their initial exposure to Nevirapine. Monitoring of patients for their liver function tests etc. is desirable prior to initiating therapy with Nevirapine and monitoring at frequent intervals once therapy with fixed dose combination is continued. Dosage adjustment : Lamivudine : For patients with low body weight (<50 kg) where dosage adjustment may be required, it is preferable not to use this fixed dose combination. 361

Zidovudine : Because it is a fixed-dose combination, this should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance 50 ml/min) or those experiencing dose-limiting adverse events. Nevirapine : For patients who experience severe rash or rash with constitutional complaints during the initial low dose Nevirapine phase of 14 days with once daily dose of 200 mg; neither, dose should be increased to twice daily nor they should receive triple fixed dose combination until the rash is resolved. Similarly for patients with abnormal liver function tests, Nevirapine therapy should be stopped till liver function return to normal and careful restart is advisable after extended observation. In event of recurrence, Nevirapine therapy can not be restarted. For patients where Nevirapine therapy has to be restarted after an interruption, daily dose of Nevirapine 200 mg for 14 days should be followed with twice daily dose in absence of any hypersensitivity reaction. Studies have not been documented to suggest dosage of Nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis. Contraindication History of hypersensitivity to Lamivudine, Zidovudine, Nevirapine and to any of the excipients available in formulation. Not to be used as initial therapy because initial therapy requires 200 mg once daily of Nevirapine whereas fixed dose combination allows for 200 mg twice daily of Nevirapine. Warning and Precautions For the following conditions, assess risk to patient and take action as needed, chronic hepatitis B, hepatomegaly with steatosis, lactic acidosis, liver function impairment, severe renal function impairment, peripheral neuropathy. Side Effects Lamivudine : Pancreatitis, paresthesia, peripheral neuropathy, cough, dizziness, fatigue, gastrointestinal problems, headache, insomnia, anaemia, neutropenia, drug induced skin, rash, hair loss.

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Zidovudine : Headache (which may be severe, has been reported in up to 63% of patients receiving Zidovudine and asthenia has been reported in 9-69%), malaise and fatigue, fever or chills, nausea (61% cases), diaphoresis, dyspnoea, rash and taste perversion have been reported. Skin rashes and myalgia has been reported in patients receiving Zidovudine. Myopathy and myositis with pathologic changes similar to that produced by HIV infection, have been associated with prolonged use of Zidovudine. The major adverse effect is bone marrow toxicity resulting in severe anaemia and/or neutropenia. Patients with low serum folate or vitamin B12 concentrations may be at increased risk for developing bone marrow toxicity during Zidovudine therapy. There also are limited data suggesting that bone marrow of patients with fulminant acquired immunodeficiency syndrome (AIDS) may be more sensitive to Zidovudine-induced toxicity than that of patients with less advanced disease (eg, AIDS-related complex [ARC]). Anaemia and granulocytopenia usually resolve when Zidovudine is discontinued or when dosage is decreased. Lactic acidosis (in the absence of hypoxaemia) and severe hapatomegaly with steatosis, including some fatalities, have been reported in patients receiving Zidovudine. Nevirapine : More frequent incidences are skin rash, diarrhoea, gastrointestinal problems, headache, nausea and stomach pain. Incidence of less frequents are aphthous stomatitis, fever, hepatitis and StevensJohnson syndrome. Pharmaceutical Precaution Store in a cool dry place. Protect from light. Keep out of reach of children. Commercial Pack Triovix Tablet : Each box contains 1 x 10s tablets in Blister strip. Each tablet contains Lamivudine INN 150 mg, Zidovudine USP 300 mg and Nevirapine INN 200 mg.

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Tripec
Syrup

Description Tripec is a combination preparation of three active ingredients namely Guaifenesin, Pseudoephedrine Hydrochloride BP and Triprolidine Hydrochloride BP. Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria. Tripec is highly palatable orange flavoured syrup. Indications Tripec is indicated for the symptomatic relief of upper respiratory tract disorders associated with common cold, allergy and other viral infections. It is used for the symptomatic treatment of productive cough. Tripec is also used to relieve symptoms of upper respiratory tract allergies e.g. sneezing, rhinorrhoea and pruritus of nose, eyes and throat. Dosage and Administration Adult and Children over 12 years Between ages 6-12 years Between ages 2-5 years or as directed by the physician. Contraindication Tripec is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy. Warning and Precautions As with any other antihistamine therapy, Tripec may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. 364 : 2 tea spoonful thrice daily : 1 tea spoonful thrice daily : tea spoonful thrice daily,

Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Tripec should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions- hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician. Side Effects CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported. Use in Pregnancy Pseudoephedrine, Triprolidine and Guaifenesin have been in widespread use without any report of ill-consequences during pregnancy. But cautions should be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Pharmaceutical Precaution Store below 25o C, protected from light. Do not refrigerate. Commercial Pack Tripec Syrup : Amber coloured glass bottle containing 100 ml highly palatable orange flavoured syrup, each 5 ml of which contains Guaifenesin BP 100 mg, Pseudoephedrine Hydrochloride BP 30 mg and Triprolidine Hydrochloride BP 1.25 mg.

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Tycil
Capsule/Suspension/Paediatric Drops

Description Tycil contains Amoxicillin (as trihydrate BP) which is chemically D(-)-amino-p-hydroxybenzylpenicillin. It is a broad-spectrum, bactericidal antibiotic similar to Ampicillin in the spectrum of activity but is better absorbed when taken orally and produces a higher blood level. Indications Tycil is indicated in the following bacterial infections Infections of the respiratory tract and ear : Laryngitis, Pharyngitis, Tonsillitis, Sinusitis, chronic and acute Bronchitis, Pneumonia and Otitis media.

Infections of the Biliary and Gastrointestinal tract : Salmonellosis, including the carrier stage, Cholecystitis, Peritonitis. Infections of the Genito-urinary tract : Nephritis, Pyelitis, Pyelonephritis, Cystitis, Urethritis and Gonorrhoea, Bacteriuria in pregnancy. Gynaecological infections including Puerperal sepsis and Septic abortion. Skin and soft tissue infections : Boils, Carbuncles, Cellulitis. Prophylaxis of endocarditis : Tycil may be used for the prevention of developing bacterial endocarditis, associated with procedures such as dental extraction. Others : Pre- and post-operative prophylaxis and treatment of infections, Septicaemia, Osteomyelitis.

Dosage and Administration Adult dosage (including elderly patients) : Standard dosage : It is 250 mg three times daily, increasing up to 500 mg three times daily for more severe infections.

Severe or recurrent infection of the respiratory tract : A dosage of 3 g twice daily is recommended in appropriate cases. (Maximum recommended oral dosage is 6 g daily in divided doses). Uncomplicated acute urinary tract infection : A single dose of 3 g.

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Gonorrhoea : A single dose of 3 g, often with 1 g probenecid in the treatment of uncomplicated gonorrhoea in areas where the pathogen is sensitive to Amoxicillin. Prophylaxis of endocarditis in susceptible patients : A single dose of 3 g about 1 hour before procedures such as dental extraction.

Children dosage: Children up to 10 years of age may be given the equivalent of 125 to 250 mg three times daily.

Children weighing 20 kg or more should be given doses according to the recommended dosage for adults. Children under 20 kg body weight a dose of 20 to 40 mg per kg daily has been suggested. In prophylaxis of endocarditis, children may be given half of the adult dose, i.e., 1.5 g about 1 hour before procedures such as dental extraction.

Contraindication Tycil is contraindicated in patients with known hypersensitivity to penicillins. Side Effects Side effects, as with other penicillins, are rare and usually of mild and transient in nature. Skin rashes may appear to some patients. This must be reported to the physician and treatment should be discontinued. Gastrointestinal complaints such as diarrhoea have occasionally been observed. These usually subside on continuation of therapy. Incidence of persistent diarrhoea should be reported to the physician. Precautions In presence of gastrointestinal diseases such as diarrhoea and vomiting, absorption of oral preparation is doubtful. Like all broad-spectrum antibiotics, superinfection may occur in association with Amoxicillin. In such cases treatment with Amoxicillin should be discontinued and appropriate therapy to combat superinfection should be instituted.

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Commercial Pack Tycil-500 Capsule : Box containing 5 blister strips of 10 capsules, each capsule contains Amoxicillin Trihydrate BP equivalent to 500 mg Amoxicillin. Tycil-250 Capsule : Box containing 10 blister strips of 10 capsules, each capsule contains Amoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin. Tycil Suspension : Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution, each 5 ml contains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin. Tycil DS Suspension : Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution, each 5 ml contains Amoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin. Tycil Paediatric Drops : Dry powder in amber glass bottle for reconstitution into 15 ml suspension. After reconstitution, each 1.25 ml contains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.

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Tynisol
Drops

Description Tynisol is a liquid preparation of multivitamin. Each 0.6 ml contains: Vitamin A Vitamin D Vitamin C Thiamine Hydrochloride Riboflavin Pyridoxine Hydrochloride Niacinamide Dexpanthenol

1.2 mg 10 g 50 mg 1 mg 0.5 mg 1 mg 5 mg 3 mg

Indications For prevention and treatment of vitamin deficiency in children and infants. Dosage and Administration Below 1 year : 9-10 drops (0.3 ml), 1 year and above : 23-25 drops (1.0 ml) once daily or as advised by the physicians. Contraindication Supplemental vitamins should not be prescribed for patients with haemochromatosis or Wilsons disease. Hypersensitivity to any of the active ingredients is a contraindication. Excessive doses of vitamin A and D can lead to hypervitaminosis. When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. Side Effects Multivitamin preparation with ordinary doses of component are usually nontoxic. 369

Pharmaceutical Precaution Keep in cool and dry place. Protect from light. Keep out of the reach of children. Commercial Pack Tynisol Multivitamin Drops : Tynisol drops is available in 15 ml amber glass bottle. Each 0.6 ml Tynisol drops contains multivitamin.

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Ultrafen
Tablet/Suppository/Gel

Description Diclofenac is a non-steroidal anti-inflammatory agent with marked analgesic, anti-inflammatory and antipyretic properties. Indications Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculo-skeletal disorders such as frozen shoulder, tendinitis, tenosynovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis, acute gout, pain in orthopaedics, dental and other minor surgery. Dosage and Administration Adults: Enteric coated tablet- A total of 75-150 mg daily given in two or three divided doses.
Sustained release tablets- One tablet daily, taken whole with liquid,

preferably during meal.

Suppositories- 75-150 mg daily in divided doses. Gel- Depending on the painful site to be treated, 2-4 g gel may be

applied 3-4 times daily. Children: Enteric coated tablet : 1-3 mg/kg per day in divided doses.
Sustained release tablets : Not recommended. Suppositories : 1-3 mg/kg body weight in divided doses.

Contraindication Ultrafen should not be given in patients with previous hypersensitivity to Diclofenac. Ultrafen should not be given to asthmatic patients and in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs.

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Precautions Ultrafen should not be prescribed to pregnant women unless there is compelling reason for doing so. Patients with a history of peptic ulcer, haematemesis, melaena, bleeding diathesis or with severe hepatic or renal insufficiency, should be kept under close surveillance. If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease or if other manifestations occur (eosinophilia, rash), Ultrafen should be discontinued. Use of Ultrafen in patients with hepatic porphyria may trigger an attack. Side Effects Epigastric pain, nausea and diarrhoea, headache and slight dizziness may be complained by some patients. These are often transient, disappearing with continuation of medication. Occasionally skin rash, peripheral oedema and abnormalities of serum transaminase have been reported. Very rarely reported side effects include activation of peptic ulcer, haematemesis or melaena, blood dyscrasia (in course of extensive usage). There have been isolated reports of anaphylactoid reactions. Accidental overdosage and treatment There is no known antidote to Ultrafen. Haemodialysis is unlikely to decrease plasma concentration due to high degree of protein binding. Pharmaceutical Precaution Store in a cool dry place. Store suppositories below 30C, keep out of reach of children. Commercial Pack Ultrafen-25 Tablet : Box containing 10 blister strips of 10 enteric coated tablets, each tablet contains Diclofenac Sodium BP 25 mg. Ultrafen-50 Tablet : Box containing 10 blister strips of 10 enteric coated tablets, each tablet contains Diclofenac Sodium BP 50 mg.

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Ultrafen 100 SR tablet : Box containing 10 blister strips of 10 sustained release tablets, each tablet contains Diclofenac Sodium BP 100 mg. Ultrafen 12.5 Suppository : Box containing 10 suppositories (2 x 5s), each suppository contains Diclofenac Sodium BP 12.5 mg. Ultrafen 50 Suppository : Box containing 10 suppositories (2 x 5s), each suppository contains Diclofenac Sodium BP 50 mg. Ultrafen 10 Gel : Tube containing 10 g Gel, each gram contains Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg. Ultrafen 25 Gel : Tube containing 25 g Gel, each gram contains Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.

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Uricon
Tablet

Description Uricon (Oxybutynin Chloride) is an antispasmodic, anticholinergic agent. Each Uricon tablet contains 5 mg of Oxybutynin Chloride USP, formulated as a once-a-day controlled release tablet for oral administration. Oxybutynin Chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, Oxybutynin Chloride increases bladder capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Uricon thus decreases urgency and the frequency of both incontinent episodes and voluntary urination. Indications Uricon is a once-daily controlled release tablet indicated for the treatment of overactive bladder with symptoms of urinary incontinence, urgency for urination, frequent urination and nocturnal enuresis. Dosage and Administration Uricon may be administered with or without food. The recommended starting dose of Uricon is 5 mg once daily. Dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. Contraindication Oxybutynin is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow angle glaucoma and in patients who are at risk for these conditions. Uricon is also contraindicated in patients who have demonstrated hypersensitivity to the drug itself or other components of the product. Side Effects The incidence of dry mouth may occur which is dose-related. Abdominal pain, dry nasal and sinus mucous membranes, back pain, hypertension, palpitation, vasodilatation, flatulence, gastro-oesophageal reflux, 374

insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin, rash, impaired urination (hesitancy), urinary retention, etc. may be reported. Precautions Uricon should be used with caution in patients with hepatic or renal impairment, clinically significant bladder outflow obstruction because of the risk of urinary retention, gastrointestinal obstructive disorders because of the risk of gastric retention, conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis, gastro-oesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate oesophagitis. Drug Interactions The concomitant use of Oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, drowsiness, and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. Pharmacokinetic studies with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g. Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics (e.g. Erythromycin and Clarithromycin), have not been performed. No specific drug-drug interaction studies have been performed with Oxybutynin. Use in Pregnancy and Lactation The safety of Oxybutynin administration to women who are or who may become pregnant has not been established. Therefore, Oxybutynin should not be given to pregnant women unless, the probable clinical benefits outweigh the possible hazards. It is not known whether Oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin is administered to a nursing woman.

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Pharmaceutical Precaution Tablets should be stored below 25o C and protected from light and moisture. Commercial Pack Uricon Tablet : Box containing 30 tablets in 3 x 10's blister strips. Each controlled release tablet contains Oxybutynin Chloride USP 5 mg.

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Uroflo
Capsule

Description Uroflo (Tamsulosin Hydrochloride) is a sulfonamethylamine derivative 1A adrenergic blocking agent. The drug is pharmacologically related to Doxazosin, Prazosin, and Terazosin; however, unlike these drugs, Tamsulosin has higher affinity and selectivity for the 1A adrenergic receptors, which are mainly located in nonvascular smooth muscle (e.g. prostate), than for 1A adrenergic receptors located in vascular smooth muscle. Such selectivity of Tamsulosin for 1A receptors may result in a reduced incidence of adverse cardiovascular effects (e.g. syncope, dizziness, and hypotension). Indications Uroflo is used in benign prostatic hyperplasia (BPH). It relaxes smooth muscle in BPH producing an increase in urinary flow rate and an improvement in obstructive symptoms. Dosage and Administration Uroflo 400 g once daily is recommended for the treatment of signs and symptoms of BPH. It should be administered approximately one and half-hour following the same meal each day. For those patients who fail to respond to the 400 g dose after 2 to 4 weeks of dosing, the dose of Uroflo can be increased to 800 g once daily. Contraindication Uroflo capsules are contraindicated in patients known to be hypersensitive to Tamsulosin or any component of the product. Uroflo should be avoided in patients with a history of orthostatic hypotension and syncope. Side Effects Side effects of Tamsulosin include drowsiness, asthenia, depression, headache, dry mouth, nausea, vomiting, diarrhoea, constipation, oedema, 377

blurred vision, rhinitis, erectile disorders, tachycardia and palpitation. Hypersensitivity reactions including rash, pruritus, angioedema have been reported in some cases. Precautions Uroflo should be avoided in patients with a history of orthostatic hypotension and syncope. Caution may be taken in the elderly and in patients with hepatic and renal impairment. Use in Pregnancy and Lactation Uroflo is not indicated for use in women. Drug Interactions The pharmacokinetic and pharmacodynamics interactions between Tamsulosin (Uroflo) and other alpha-adrenergic blocking agents have not been determined. However, interactions may be expected and it should not be used in combination with other alpha-adrenergic blocking agents. The pharmacokinetic interaction between Cimetidine and Tamsulosin was investigated. Caution should be exercised with concomitant administration of Warfarin and Tamsulosin. Pharmaceutical Precaution Store at controlled room temperature 20C to 25C. Keep away from children. Commercial Pack Uroflo Capsule : Each box containing 20 capsules in 2 x 10's blister strips. Each modified release capsule contains Tamsulosin Hydrochloride INN 400 g.

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Valcap
Capsule

Description Valcap (Valsartan) is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4yl]methyl]-L-valine. Indications For the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Dosage and Administration The recommended dose of Valcap is 80 mg once daily, irrespective of race, age, or gender. The antihypertensive effect is substantially present within 2 weeks and maximal effects are seen after 4 weeks. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 160 mg or 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. No dosage adjustment is required for patients with renal impairment or for patients with hepatic insufficiency of non-biliary origin and without cholestasis. Valcap may also be administered with other antihypertensive agents. The safety and efficacy of Valcap have not been established in children. Contraindication Hypersensivity to Valsartan or any of the components of the product. Drug Interactions No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Frusemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine, Glibenclamide. As Valcap is not metabolized to a significant extent, clinically relevant 379

drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitro studies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Frusemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g. Spironolactone, Triamterene, Amilorid) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co-medication is considered necessary, caution is advisable. Side Effects The overall incidence of adverse experiences with Valsartan was similar to placebo. The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, rhinitis, sinusitis, pharyngitis, oedema and fatigue. Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Valsartan 320 mg compared to 80-160 mg. Use in Pregnancy and Lactation Due to the mechanisms of action of angiotenin II antagonists, a risk for the foetus cannot be excluded. In utero exposure to angiotensin converting enzyme (ACE) inhibitors given to pregnant women during the 2nd and 3rd trimesters has been reported to cause foetal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. As for any drug that also acts directly on the renin angiotensin-aldosterone system (RAAS). When pregnancy is detected, Valcap should be discontinued as soon as possible. It is not known whether Valsartan is excreted in human milk. Valsartan was excreted in the milk of lactating rats. Thus, it is not advisable to use Valcap in lactating mothers. Overdosage Although there is no experience of overdose with Valcap, the major sign that might be expected is marked hypotension and tachycardia. If the ingestion is recent, vomiting should be induced. Otherwise, the usual treatment would be intravenous infusion of normal saline solution.

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Valsartan is unlikely to be removed by haemodialysis. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Pharmaceutical Precaution Should be kept away from moisture and heat. Keep out of the reach of children. Commercial Pack Valcap Capsule : Box containing 30 capsules in 3 x 10's blister strips. Each capsule contains Valsartan INN 80 mg. Valcap 160 Capsule : Box containing 30 capsules in 2 x 10's blister strips. Each capsule contains Valsartan INN 160 mg.

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V-Cox
Tablet

Description V-cox (Valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action is believed to be due to inhibition of prostaglandin synthesis primarily through inhibition of the enzyme cyclooxygenase-2 (COX-2). At therapeutic plasma concentration in human Valdecoxib does not inhibit cyclooxygenase-1 (COX-1). Indications V-cox is indicated :

For relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA). For the treatment of primary dysmenorrhoea.

Dosage and Administration Osteoarthritis and Adult Rheumatoid Arthritis The recommended dose of V-cox for the relief of the signs and symptoms of arthritis is 10 mg once daily. Primary Dysmenorrhoea The recommended dose of V-cox for treatment of primary dysmenorrhoea is 20 mg twice daily, or as needed. Paediatric Use Safety and effectiveness of V-cox in paediatric patients below the age of 18 years have not been evaluated. Contraindication Valdecoxib is contraindicated in patients with known hypersensitivity to Valdecoxib or any component of the product. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking Aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Valdecoxib should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

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Precautions Treatment with Valdecoxib should be initiated with caution in patients with mild to moderate hepatic impairment and fluid retention. The use of Valdecoxib in patients with severe hepatic impairment is not recommended. No information is available regarding the safe use of Valdecoxib in patients with advanced kidney disease. Therefore, treatment with V-cox is not recommended in these patients. If therapy with V-cox must be initiated, close monitoring of the patient's kidney function is advisable. Side Effects Gastrointestinal events include abdominal fullness, abdominal pain, diarrhoea, dyspepsia, flatulence and nausea. Valdecoxib may cause dizziness and headache. In few cases, it may cause back pain, peripheral oedema, influenza-like syndrome, and hypertension. Myalgia, sinusitis and skin rash may occur. In the seven osteoarthritis and rheumatoid arthritis controlled studies, the adverse events occurred in 0.1-1.9% of patients treated with V-cox 10 -20 mg daily. Drug Interactions Aspirin : Concomitant administration of Aspirin with Valdecoxib may result in an increased risk of gastrointestinal ulceration and complications compared to Valdecoxib alone. Methotrexate : Valdecoxib 10 mg bid did not show a significant effect on the plasma exposure or renal clearance of Methotrexate. ACE inhibitors : Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking Valdecoxib concomitantly with ACE inhibitors. Frusemide : Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the effect of Frusemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

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Anticonvulsants : Anticonvulsant drug interaction studies with Valdecoxib have not been conducted. As with other drugs, routine monitoring should be performed when therapy with Valdecoxib is either initiated or discontinued in patients on anticonvulsant therapy. Fluconazole and Ketoconazole : Concomitant single dose administration of Valdecoxib 20 mg with multiple doses of Ketoconazole and Fluconazole produced a significant increase in action of Valdecoxib. Use in Pregnancy and Lactation There are no studies in pregnant women. However, Valdecoxib crosses the placenta in rats and rabbits. V-cox should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. The effects of V-cox on labour and delivery in pregnant women are unknown. V-cox is contraindicated in nursing mother. Overdosage Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Warning Serious gastrointestinal toxicity such as bleeding, ulceration and perforation of the stomach, small intestine or large intestine can occur at any time with or without warning symptoms in patients treated with NSAIDs. Minor gastrointestinal problems such as dyspepsia are common and may also occur at any time during NSAID therapy. General Information V-cox can be taken with or without food. Any food had no significant effect on either the peak plasma concentration or extent of absorption of Valdecoxib. No significant effect on either the rate or extent of absorption of Valdecoxib has occurred by concomitant administration of Valdecoxib with antacid (aluminium/magnesium hydroxide).

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Pharmaceutical Precaution Store at 25C. Keep away from children. Commercial Pack V-cox 10 Tablet : Box containing 10 x 10's tablets in blister strips. Each film coated tablet contains Valdecoxib INN 10 mg. V-cox 20 Tablet : Box containing 5 x 10's tablets in blister strips. Each film coated tablet contains Valdecoxib INN 20 mg.

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Xynofen-100 SR
Capsule

Description Xynofen-100 SR (Ketoprofen) is a derivative of propionic acid which is widely used in the treatment of patients with rheumatic diseases. It is a potent non-steroidal anti-inflammatory analgesic agent and a strong inhibitor of prostaglandin synthetase. Indications Rheumatic diseases : for anti-inflammatory and analgesic use in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

Periarticular and musculoskeletal indications : for analgesia in bursitis, tendinitis, synovitis, tenosynovitis, lumbago. Prophylaxis and treatment of migraine headache. Surgical and traumatic uses : for analgesic action after sports injuries, orthopaedic manipulations, dental extraction, surgery. Infectious diseases : for analgesic, anti-inflammatory and antipyretic purposes. Gynaecological uses : in dysmenorrhoea, following IUCD insertion and for uterine relaxation and analgesia in the post-partum, non-nursing mother.

Dosage and Administration Xynofen-100 SR is administered orally, in the dose of 100-200 mg once daily, usually with food, depending on patient weight and on severity of symptoms. Contraindication Hypersensitivity to Ketoprofen

Patients with rhinitis, nasal polyps and asthma associated with Aspirin may show cross sensitivity with other NSAIDs including Ketoprofen Patients with active ulceration or chronic dyspepsia Severe renal insufficiency 386

Side Effects Minor side effects are variable in severity and frequency, consisting mostly of gastrointestinal problems such as gastrointestinal discomfort, nausea, diarrhoea and occasionally bleeding and ulceration. Dyspepsia may be minimized by taking this drug with food or milk. Other minor side effects such as headache, dizziness, mild confusion, vertigo, drowsiness, oedema, mood change and insomnia may occur less commonly. Major side effects involving other organ systems such as haematological reactions, hepatic or renal damage, dermatological reactions, bronchospasm and anaphylaxis are exceedingly rare. In all cases of major side effects Xynofen-100 SR should be withdrawn at once. Precautions Inhibition of renal prostaglandin synthesis by NSAIDs may interfere with renal function especially in the presence of existing renal disease. Ketoprofen should therefore be used with caution in patients with renal impairment. To minimize gastric intolerance, Xynofen-100 SR capsule should always be taken with food. Use in Pregnancy and Lactation The drug should not be used in pregnancy unless clearly needed. It is not recommended for nursing mother as it is excreted through breast milk. Drug Interactions Warfarin, Sulphonamide, Hydantoin : Ketoprofen is highly protein bound. Theoretically, interaction is possible following concomitant use of other protein bound drugs, for example anticoagulants, sulphonamides, and hydantoin. Digoxin, Methotrexate, Cyclosporin : Like other NSAIDs, Ketoprofen, through effects on renal prostaglandin, may cause increased toxicity of certain drugs. Serum levels of Digoxin and Methotrexate may be elevated; also there may be increased nephrotoxicity with Cyclosporin when used concomitantly with Ketoprofen. 387

Aspirin : Concomitant administration of Aspirin and Ketoprofen is not recommended as it decreases the plasma concentration of Ketoprofen. Lithium : Ketoprofen decreases the renal clearance of Lithium and increases the plasma level of Lithium. So, Lithium toxicity may develop. Diuretics : Ketoprofen may reduce the activity of the diuretics. -blockers : Ketoprofen may reduce the antihypertensive effect of blockers. Oral hypoglycaemics : Ketoprofen may alter the response to insulin or oral hypoglycaemic agents. Overdosage In case of acute overdosage, it is recommended that stomach be emptied by vomiting or lavage. The use of activated charcoal orally may also be helpful. Commercial Pack Xynofen-100 SR Capsule : Box containing 50 capsules in 5 x 10s blister strips, each capsule contains Ketoprofen BP 100 mg as sustained release pellets.

388

Yamadin
Tablet

Description The active ingredient of Yamadin-20 and Yamadin-40 tablet is Famotidine. Famotidine is a novel, highly specific and potent competitive H 2 receptor antagonist. It has a rapid onset and prolonged duration of action. After oral administration, the onset of the antisecretory effect occurs within one hour and lasts for at least 12 hours by doses of 40 mg. Famotidine reduces the acid and pepsin content, as well as the volume of basal, nocturnal and stimulated gastric secretion. Food or antacid does not interfere its absorption. Indications Yamadin is indicated in Short term treatment of active duodenal ulcer and benign gastric ulcer Maintenance therapy for prevention of relapses of duodenal ulceration Gastro-oesophageal reflux disease Zollinger-Ellison Syndrome Dosage and Administration Duodenal ulcer : 40 mg at night for 4 to 8 weeks; Benign gastric ulcer : 40 mg at night for 4 to 8 weeks; Maintenance therapy : 20 mg at night for preventing the recurrences of duodenal ulceration; Gastro-oesophageal reflux disease : 20 mg twice daily for 6 to 12 weeks; Zollinger-Ellison Syndrome : The recommended starting dose is 20 mg every six hours. Dosage should then be adjusted to individual response. Doses up to 160 mg every six hours have been administered to some patients without the development of significant adverse effects. Dosage can be administered irrespective of meals. Antacids may be given concomitantly if needed. Side Effects Yamadin is generally well tolerated and side effects are uncommon. Dizziness, headache, constipation and diarrhoea have been reported 389

rarely. Other side effects reported less frequently include dry mouth, nausea and/or vomiting, rash, abdominal discomfort, anorexia and fatigue. Contraindication There are no known contraindication to Yamadin. If any evidence of hypersensitivity appear, the therapy should be discontinued and consultation with physician is required. Precautions Dosage reduction should be considered or interval between doses should be prolonged if creatinine clearance falls to or below 30 ml/min. Use in Pregnancy and Lactation There are no adequate, well-controlled studies on Famotidine in pregnancy, but it is known to cross the placenta and should be prescribed only if clearly needed. It is not known whether Famotidine is secreted into human milk, nursing mothers should either stop nursing or stop taking the drug. Drug Interactions Yamadin does not interact with the cytochrome P450 linked drug metabolizing enzyme system. So, no interactions have been found in man with Warfarin, Theophylline, Phenytoin, Diazepam, Propranolol, Aminopyrine or antipyrine. Pharmaceutical Precaution Store in a dry place below 25 0 C. Commercial Pack Yamadin-20 Tablet : Each round, film coated tablet contains 20 mg Famotidine USP. Box containing 10 blister strips of 10 tablets. Yamadin-40 Tablet : Each round, film coated tablet contains 40 mg Famotidine USP. Box containing 10 blister strips of 10 tablets.

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ZedexDS
Syrup

Description Zedex DS (Zinc Sulphate) is a source of Zinc which is an essential trace element and involved in a number of body enzyme systems. Zinc salts are used as supplements to correct Zinc deficiencies. The consequences of Zinc deficiency are malformations of the brain, eyes, bones, heart and other organs. Zinc is essential for the formation and function of the immune system. Systems influenced by Zinc include the reproductive, neurologic, immune, dermatologic and gastrointestinal systems. Indications Zinc deficiency states Growth retardation, respiratory tract infection, alopecia, dermatitis, diarrhoea, immunologic dysfunction, psychological disturbances, gonadal atrophy, impaired spermatogenesis, congenital malformations, acrodermatitis enteropathica. Dosage and Administration Children under 10 kg : 22.5 mg (2 tea spoonful) daily in divided doses. Children within 10 to 30 kg : 22.5 mg (2 tea spoonful) 1 to 3 times daily after food. Adults and children over 30 kg : 45 mg (4 tea spoonful) 1 to 3 times daily after food or as directed by the physician. Side Effects Zinc salts may cause abdominal pain and dyspepsia. Prolonged use may lead to copper deficiency and anaemia. It can be converted to the corrosive Zinc Chloride, and it is this corrosive action that accounts for the acute toxicity of the soluble Zinc salts. Drug Interactions Zinc may inhibit the absorption of concurrently administered Tetracyclines, therefore, an interval of at least 3 hours should be allowed while taking these products. 391

Contraindication It is contraindicated in patients with hypersensitivity to Zinc. Special Warning and Precautions Accumulation of Zinc may occur in case of renal failure. Overdosage Zinc sulphate is corrosive in overdosage. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach; ulceration of the stomach followed by perforation may occur. Gastric lavage and emesis should be avoided. Demulcent such as milk should be given. Chelating agents such as sodium edetate may be useful. Pharmaceutical Precaution Store in a cool and dry place, keep away from light. Commercial Pack Zedex DS Syrup : 100 ml syrup in amber glass bottle. Each 5 ml contains Zinc Sulphate Monohydrate USP equivalent to 10 mg of elemental Zinc.

392

Zocil
Tablet

Description Cilostazol (Zocil) is a quinolinone derivative. The mechanism of action is to specifically inhibit cellular phosphodiesterase III (PDE III) and suppress cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation. Indications Zocil is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance. Dosage and Administration The recommended dosage of Zocil is 100 mg bid, taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg bid should be considered during coadministration of Ketoconazole, Itraconazole, Erythromycin, and Diltiazem. Side Effects The most common side effects are headache, diarrhoea, vomiting, leg cramps, rash etc. The less frequent side effects are anorexia and oedema. Contraindication Zocil is contraindicated in patients with congestive heart failure of any severity. Zocil is also contraindicated in patients with known or suspected hypersensitivity to any of its components. Precautions Zocil should be used with caution in patients with any degree of heart failure. There is no information with respect to the efficacy or safety of the concurrent use of Cilostazol and Clopidogrel. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. Transfer of Cilostazol into milk has been reported in experimental

393

animals. Because of the potential risk to nursing infants, a decision should be made to discontinue nursing or to discontinue Zocil. Paediatric Use The safety and effectiveness of Zocil in paediatric patients have not been established. Drug Interactions Pharmacokinetic studies have demonstrated that Omeprazole and Erythromycin significantly increased the systemic exposure of Cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of Cilostazol among patients concurrently treated with Diltiazem. Overdosage Information on acute overdosage with Zocil in humans is limited. The signs and symptoms of an acute overdose are severe headache, diarrhoea, hypotension, tachycardia, and possibly cardiac arrhythmias. The patient should be carefully observed and given supportive treatment. Pharmaceutical Precaution Keep in a cool (25 oC) and dry place. Keep out of the reach of children. Commercial Pack Zocil 50 Tablet : Box containing 30 tablets in 3 x 10s blister strips. Each tablet contains Cilostazol INN 50 mg. Zocil 100 Tablet : Box containing 20 tablets in 2 x 10s blister strips. Each tablet contains Cilostazol INN 100 mg.

394

Zukast
Tablet

Description Zukast (Zafirlukast) is a synthetic, selective peptide leukotriene receptor antagonist (LTRA) that acts as a prophylactic agent against inflammation in asthma. Cysteinyl leukotriene production and receptor occupation have been correlated with the pathophysiology of asthma, including airway oedema, smooth muscle constriction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Indications Zukast is indicated for the treatment of asthma. Dosage and Administration Zukast should be taken continuously. Children under 7 years of age : There is no clinical experience of the use of Zukast in children under 7 years of age until safety information is available. Children over 7 years through 11 years of age : The recommended dose of Zukast in this age group is 10 mg twice daily. Adult and children aged 12 years and over : The dosage is one 20 mg tablet twice daily. This dosage should not be exceeded. Higher doses may be associated with elevations of one or more liver enzymes consistent with hepatotoxicity. As food may reduce the bioavailability of Zafirlukast, Zukast should not be taken with meals. Elderly : The clearance of Zafirlukast is significantly reduced in elderly patients (over 65 years old), and Cmax and AUC are approximately double than those of younger adults. However, accumulation of Zafirlukast is not greater than that seen in multiple-dose trials conducted in adult subjects with asthma and the consequences of the altered kinetic in the elderly are unknown. Clinical experience with Zukast in the elderly (over 65 years) is limited and caution is recommended until further information is available. No dosage adjustment is necessary in patients with mild renal impairment.

395

Contraindication Zukast should not be given to patients who have previously experienced hypersensitivity to the product or any of its ingredients. Zukast is contraindicated in patients with a history of moderate or severe renal impairment. Zukast is contraindicated in patients with hepatic impairment or cirrhosis; it has not been studied in patients with hepatitis or in long term studies of patients with cirrhosis. Zukast is contraindicated in children under 7 years of age until safety information is available. Warning and Precautions Zukast should be taken regularly to achieve benefit, even during symptom-free periods. Zukast therapy should normally be continued during acute exacerbations of asthma. Zukast does not allow a reduction in existing steroid treatment. As with inhaled steroids and cromones (disodium cromoglycate, nedocromil sodium), Zukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Zukast has not been evaluated in the treatment of labile (brittle) or unstable asthma. Cases of Churg-Strauss Syndrome have been reported in association with Zukast usage. A causal relationship has neither been confirmed nor refuted. If a patient develops a Churg-Strauss Syndrome type illness, Zukast should be stopped, a re-challenge test should not be performed and treatment should not be restarted. Elevations in serum transaminases can occur during treatment with Zukast. These are usually asymptomatic and transient but could represent early evidence of hepatotoxicity. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g. nausea, vomiting, right upper quadrant pain, fatigue, lethargy, flu-like symptoms, enlarged liver, pruritus and jaundice), the serum transaminases, in particular serum ALT, should be measured and the patient managed accordingly. A decision to discontinue Zukast should be individualized to the patients condition, weighing the risk of hepatic dysfunction against the clinical benefit of Zukast to the patient.

396

Drug Interactions Zukast may be administered with other therapies routinely used in the management of asthma and allergy. Inhaled steroids, inhaled and oral bronchodilator therapy, antibiotics and antihistamines are examples of agents which have been co-administered with Zukast without adverse interaction. Zukast may be administered with oral contraceptives without adverse interaction. Co-administration with Warfarin results in an increase in maximum prothrombin time by approximately 35%. It is therefore recommended that if Zukast is co-administered with Warfarin, prothrombin time should be closely monitored. The interaction is probably due to an inhibition by Zafirlukast of the cytochrome P450 2C9 enzyme system. In clinical trials co-administration with Theophylline resulted in decreased plasma levels of Zafirlukast, by approximately 30%, but with no effect on plasma Theophylline levels. However, during postmarketing surveillance, there have been rare cases of patients experiencing increased Theophylline levels when co-administered with Zafirlukast. Co-administration with Terfenadine resulted in a 54% decrease in AUC for Zafirlukast, but with no effect on plasma terfenadine levels. Coadministration with Acetylsalicylic acid (650 mg four times a day) may result in increased plasma levels of Zafirlukast, by approximately 45%. Co-administration with Erythromycin will result in decreased plasma levels of Zafirlukast, by approximately 40%. The clearance of Zafirlukast in smokers may be increased by approximately 20%. Use in Pregnancy and Lactation The safety of Zukast in human pregnancy has not been established. In animal studies, Zafirlukast did not have any apparent effect on fertility and did not appear to have any teratogenic or selective toxic effect on the foetus. The potential risks should be weighed against the benefits of continuing therapy during pregnancy and Zukast should be used during pregnancy only if clearly needed. Zafirlukast is excreted in human breast milk. Zukast should not be administered to nursing mothers.

397

Side Effects Effect on ability to drive or operate machinery : There is no evidence that Zukast affects the ability to drive and use machinery. Administration of Zukast in clinical trials against placebo has been associated with headache (9.9% vs. 9.0%) or gastrointestinal disturbance (nausea 2.6% vs. 2.2%, vomiting 1.2% vs. 1.0%, diarrhoea 2.3% vs. 1.8%, abdominal pain 1.6% vs. 1.2%). These symptoms are usually mild and do not necessitate withdrawal from therapy. During post-marketing experience, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopaenia and agranulocytosis (very rare) have also been reported. Hypersensitivity reactions, including urticaria and angioedema have been reported. Rashes, including blistering, have also been reported. The above events have usually resolved during continued treatment or following cessation of therapy. Infrequently, elevated serum transaminase levels have been observed in clinical trials against placebo with Zafirlukast (increased AST 1.0% vs. 0.9%, increased AST 0.6% vs. 0.6%); at recommended doses the incidence was equivalent to placebo. Rarely the transaminase profile has been consistent with drug-induced hepatitis, which resolved following cessation of Zukast therapy. During post-marketing experience there have been rare reports of hepatitis, with or without elevated bilirubin levels. These cases were usually reversible. In placebo-controlled clinical trials, an increased incidence of infection has been observed in elderly patients given Zafirlukast (7.8% vs. 1.4%). Infections were usually mild, predominantly affecting the respiratory tract. Overdosage No information exists with regard to the effects of overdosage of Zukast in humans. Management should be supportive. Removal of excess medication by gastric lavage may be helpful. Pharmacological Properties The cysteinyl leukotrienes (LTC4, LTD4 and LTE4) are potent inflammatory eicosanoids released from various cells including mast cells

398

and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors found in the human airway. Leukotriene production and receptor occupation has been implicated in the pathophysiology of asthma. Effects include smooth muscle contraction, airway oedema and altered cell activity associated with the inflammatory process, including eosinophil influx to the lung. Zukast is a competitive, highly selective and potent oral peptide leukotriene antagonist of LTC4, LTD4 and LTE4 components of slow reacting substance of anaphylaxis. In vitro studies have shown that Zukast antagonizes the contractile activity of all three peptide leukotrienes (leukotriene C4, D4 and E4) in human conducting airway smooth muscle to the same extent. Animal studies have shown Zafirlukast to be effective in preventing peptide leukotriene-induced increases in vascular permeability, which give rise to oedema in the airways, and to inhibit peptide leukotriene-induced influx of eosinophils into airways. The specificity of Zukast has been shown by its action on leukotriene receptors and not prostaglandin, thromboxane, histamin, and cholinergic receptors. Peak plasma concentrations of Zafirlukast are achieved approximately 3 hours after oral administration of Zukast. Administration of Zukast with food increased the variability in the bioavailability of Zafirlukast and reduced bioavailability in most (75%) subjects. The net reduction was approximately 40%. Following twice-daily administration of Zukast (30 to 80 mg bid), accumulation of Zafirlukast in plasma was low (not detectable - 2.9 times first dose values; mean 1.45; median 1.27). The terminal half-life of Zafirlukast is approximately 10 hours. Steady-state plasma concentrations of Zafirlukast were proportional to the dose and predictable from single-dose pharmacokinetic data. Zafirlukast is approximately 99% protein bound to human plasma proteins, predominantly albumin, over the concentration range 0.25 to 4.0 g/ml. Zafirlukast is extensively metabolized. Following a radiolabelled dose the urinary excretion accounts for approximately 10% dose and faecal excretion for 89%. Zafirlukast is not detected in urine. Elderly subjects and subjects with stable alcoholic cirrhosis demonstrated an approximately two-fold increase in C max and AUC compared to 399

normal subjects given the same doses of Zukast. There are no significant differences in the pharmacokinetics of Zafirlukast in patients with mild renal impairment and in normal subjects. Pharmaceutical Precaution Store below 30o C. Protect from light and moisture. Commercial Pack Zukast Tablet : Box containing 10 tablets in 1 x 10s alu-alu form pack, each tablet contains Zafirlukast INN 20 mg.

400

Zymet
Tablet Description Zymet is a preparation of mammalian pancreas containing enzyme protease, lipase and amylase activity. Each gram of pancreatin contains 1400 FIP units of protease activity, 20000 FIP units of lipase activity and 24000 FIP units of amylase activity. Use To compensate for reduced intestinal enzyme activity in pancreatic deficiency states. Indications Children : In children with reduced or absence of pancreatic exocrine secretion, and Cystic fibrosis. Adults : In the conditions with deficient pancreatic exocrine function such as Following pancreatectomy Following total gastrectomy Chronic pancreatitis. Dosage and Administration 1-3 tablets daily with meal or as per direction of the physician. Side Effects Zymet may cause buccal and perianal soreness, particularly in infants. Hypersensitivity reactions have been reported; these may be sneezing, lacrimation or skin rashes. Precautions Zymet should be used with caution in patients known to be allergic to animal protein. Pharmaceutical Precaution Keep in a cool, dry place. Keep out of the reach of children. Commercial Pack Zymet Tablet : Box containing 100 tablets in 10 x 10s blister strips, each sugar and enteric coated tablet contains Pancreatin BP 325 mg. 401