INHAVENT: Ipratropium bromide 0.5 mg andiSalbutamol 2 mg Se Inhalation\Fluid Re eet Right Combinati i _ Bi Bronce fin a trolling carenie Obsteuetive (AMeney DIBECS eel Asha ayAttacksNumber of patients stay in emergency unit during treatment with Ipratropium bromide + Salbutamol * = | 2 a i salbutamol group 40 = 5 30 & 20 2 = [pratropuim bromide + salbutamol 50 group 2 # 0 30 60 90 TIME (MINUTE) At 30-minute from admission to ER the number of patients who stay in emergency room were 50 patients. After 60 minute, the number of patients in Salbutamol group decreased to 48 patients and 35 for Ipratropium Bromide + Salbutamol group with a significant difference in number of patients, At the end of 90 minutes there were 28 patients from Salbutamol group and 11 patients from Salbutamol + Ipratropium Bromide group. So that the combination of Salbutamol + Ipratropium Bromide reduces the time of hospitalization. Comparison of pulmonary function with addition of Ipratropium bromide and Salbutamol in acute severe asthma ” AFEV, (ml) DRS BOR 455" = 607 See 90) Time after start of nebulization (minutes) *p<0.05 §--Bipss @—@s Significant improvement in lung function is associated with the addition of Ipratropium to Salbutamol in the initial management of acute severe asthma.Clinical and lung function parameters at the Characteristic Salbutamol plus Ipratropium bromide Salbutamal plus placebo Pavalue Number 49 48 Sa0x (%) 950424 922419 0004 Asthma score 17#24 97424 0001 Hospital admission (%) 9s 184 214438 oor Lung function (n) 32 33 °% of predicted FEV: 97425 69410 (0001 % of predicted PEF sg421 eg412 004 Note: Data presented as percentages ormean + SO, Administration of Salbutamol + Ipratropium Bromide presented a significantly greater improvement in clinical parameters (pulmonary asthma score and SaO2) and pulmonary function (FEV1 and PEF) and significantly lower need for hospitalization in the treated patients. References 1 Almusani Z.M. Abood, HA. & Alfa, A.M (2018) A Comparative Stuy of Salb.taol Nebulizer versus Salbutamol plus Budesonide Nebulzerin the Treatment of Children with Acute Asthma Exacerbation. International Journal of Research in Pharmaceutical Sciences, 9(SPLi). 2. Garret, J, Town, G. 1, Rodwel, P, & Kel, A.M. (1997). Nebulzed salbutamol wih and without pratopium bromide nthe treatment of acute asta. Journal of Alergy and Cincal Immunology, 1002), 165-170. 8. remain, RL ‘feesin chron. Jour of Asta, 48(3), 298-903, Herc J, Coronel, Spits, C., Guggla 8 Bogeco, N. 2017). Intaedselbtamo pls pratopiom in moderate and severe asthma INHAVENT Ipratropium bromide 0.5 mg and Salbutamol 2.5 mg ‘COMPOSITIONS : Inhavent” Inhalation fuid, each ampoule contains: Ipratropium bromide 0.5 mg and Saloutamol sufate 2.5 mg, PHARMACOLOGY lratopum bromides 2 quatmary anmoniam compound ith ~anticholinergc (parasympatholytic) ropertes. Innoncincal stu, it appears to inhibit vagally mediated reflexes by antagonizing the action of acetycholin, the transmitter agent released from the vagus ne. Anchcnergis prevent he crease intaceliar ‘concentration of Ca" wich is caused by interaction of acetyicholne with the muscarinic receptor on bronchial smooth muscle. Ca" release is mediated by the second messenger system consisting ‘of 1P3 (Inositol triphosphate) and DAG (Diaoylglycero). ‘Salbutamol sulfate isa fzadrenergic agent which acts on airway ‘smooth muscle resulting in relaxation. Salbutamol relaxes al ‘smooth muscle from the trachea tothe terminal bronchioles and protects agains ll bronchoconstictor challenges. Inhavent® provide the simultaneous release of ratropium bromide ‘and Sabutam sufate alowing the aditve effec on both muscarinic ‘and radrenergc receptors in the lung resulting in a bronchadlation PICS USI Fa wooo by a ate eae Inhavent® have a greater bronchodiator effet then either ofits ‘components in patients with reversible bronchospasm and there \was no potentiation of adverse events Inhavent’ easy to use patients with minimal cogriive abilities and ‘no need for hand breath coordination, manual dexterity or hand strength, INDICATIONS : Inhavent® is indicated for the management of reversible ~ branchaspasm associated with obstructive pulmonary diseases Inhalation fluid ‘and acute asthma attack inpatient who require more than single bronchodilator. DOSAGE AND ADMINISTRATIONS : The following doses of nhiavent® are recommended for aduits (including eldery patients) Inhavent® inhalation solution in ampoule may be administrated from a suitable nebulizer or an intermittent positive pressure Ventilator. Treatment should be initiated and administered under medical supervision. Home based treatment can be recommended ‘on exceptional cases (severe symatoms or experienced patients requiring higher doses) when a low dose rapid acting B-agonist bronchodilator has been insufficient in providing relief after consultation wih an experienced physician, The treatment wih the nebulizer solution in ampoule should aay, be started with the lowest recommended dose (1 ampoule). In very severe cases two ampoules may be requited for symptom rel, ‘Adminstration should be stopped when sufcient symptoms rele is achieved, Treatment of acute attacks : 4 ampoule is sufficient for prompt symptom rele in many cases. In severe cases if an altack has nol been relieved by 1 ampoule, 2 ampoules may be required In these cases, patents should consult the doctor or the nearest, hospital immediately. Maintenance treatment; 1 ampoue three or four time daly Inhavent® has not been studied in patents with hepatcor renal insufficiency. It should be used with caution in those patient populations.me JINHAVENT™ ipratropium bromidey0!5jmgland|Salbutamol 2.5 mg Inhalation Fluid Coniietion of Beichociiators in Controlling Lulinenciy Dissass ond Asthma Anachs Patients should be advised to consult a physician or the nearest hospital immediately in the case of acute or rapidly worsening ddyspncea if addtional inhalations of Inhavent® do not produce an adequate improvement If higher than recommended doses of Inhiavent® are required to, Control symptoms, the patients therapy plan should be reviewed. Instruction for use ‘Ampoule are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally. The content of the ampoule does not need to be diluted for nebulization. 4 1.Tum down the content from the neck of ‘ampoule by tapping a finger on ampoule or ‘ampoule being shaken in a circular motion downward, \\] 2.Protect your fingers with gauze if ampoule is made of glass. 3.Break the top of the ampoule carefully. 4,Remove the liquid into the nebulizer and use as directed. 5.Assemble the nebulizer and use as directed. 6.After use throw away any solution left in the reservoir and clean the nebulizer, following the manufacturers instructions, sq ‘Since the ampoule contain no preservative, itis important thatthe Contents are used soon after opening and that afresh ampoule is, used for each administration to avoid microbial contamination Partly used, opened or damaged ampoule shouldbe discarded. itis strongly recommended nat to mix inhavent® solution for inhalation with other drugs in the same nebulizer. CONTRAINDICATIONS : Hypertrophic obstructive cardiomyopathy, tachyarrhythmia, hypersensitivity to any ofthe components ofthe product, to atropine ois derivatives, INTERACTIONS : + The chronic co-administration of Inhavent® with other ‘anticholinergic drugs has not been studied. Therefore, the chronic ‘co-administration of inhavent® with other anticholinergic drugs {snot recommended. ‘The concurrent administration of xanthine derivates as well as per ‘Beadrenergics and anticholinergics may increase the side ts. a-agonst induced hypokalemia may be increase by concomitant {reatment with xanthine derivates, lucocoricosteroids and ‘durets. Ths shouldbe taken into aocount parculry in patents with severe airway obstruction. Hypokalemia may result in an increased susceptibility to ‘arrhythmias in patients receiving digoxin. Its recamended that serum potassium levels are monitored in such situations. + noel serauseduionnironchdier eect ay oo blockers + Paradrenergio agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or theylc antidepressants, since the action of frradrenersic agonist may be enhanced) + Inhalation of halogenated hydrocarbon anaesthetics such as halothane, tichloroethylene and enflurane may increase the suscepti to the cardiovascular effects of Ba-agonists ‘ADVERSE REACTIONS : Many of the listed undesirable effects can be assigned to the anticholinergic and fi-sympathomimetic properties of Inhavent® ‘As with al inhalation therapy inhavent® may show symptoms of local nitaton. The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, {gastrointestinal motity disorders (incuding constipation, diarhea and vomiting), nausea, and dizziness. PRESENTATIONS : Inhavent® Inhalation fuid Box, 5 ampoules @ 2.5mi Reg. No. DKL2002362668A1 STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT ‘ON MEDICAL PRESCRIPTION ONLY REFERENCES : {Litamain, R, Lépez-Herce, J. Coronel, J, Spier, C., Guggia J, & Bogedo, (2011). Intad sloutamal pus xatropum in madera and ‘severe asia crses in chlren Journal of Ast, 49(3), 228-908, 2, Amusani, 2. Abcod, HA, & Alfachi, AM. (2018). A Comparative ‘Study of Sabiaol Nebulizer versus Sabutaal pis Bucesonde Nebulzar inthe Treatment of Chicren wih Acule Asta Exacerbation. Intemational Joumal of Research in Pharmaceutical Sclnoes, (SPL), 3, Donohue JF, Wisp, R Buse, W.W. Gare S. 2ubsk VB. Ghafour, W Mani RC. Sihinerties Ges E.R 2016 Ear) and safely of ipratropium bromide albuterol compared with albuterol in Bales mh regret sae atte Aranda contol tl IC Pulmonary Medicine, 16), 1-15, 4, Chassany, 0, Fuberton,&., Rodrigo, GJ, & Rodrigo, C (2000). Meta ana) he eect rapt rari radu wih act atin it American Joumal of Medicine, 108(7), 596-57, s fas = GE) Aor of abled ig delivery in COPD. tenor uel COBH), 25852580 Ia @ © 68 cmt No 101202205 For futher infomation, please contectus at: BERNOFARM Kompleks Harmoni Plaza Blok J9 - J4 4, Suryopranoto Jakarta Pusat 10130 Prone 62 21 6318548, Fax. 6221 6318015 e-mail: info@bernofarm.com