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    26 views1 page

    Drenex 533

    Uploaded by

    JackTV

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 1
    DEXAMETHASONE DRENEX® inter CORTICOSTEROID FORMULATION Each abet contains: Dexamethasone 750 meg or 3 mq PRODUCT DESCRIPTION Doxamethasone (DRENEX* 750 mcg) is aight bo, ound $2" in diameter, ft bovelodgod, plain abl, isctd on on side an pan onto other si. Dexamethasone (DRENEX' 3 mgs yelow, und, /16"in dameter, bevel-edged table, bisected on one side and plain on the overs, CLINICAL PHARMACOLOGY Pharmacodynamics Dexamethasone isa highly polent and long-acting glucocorticoid whose main pharmacological actons include: (a) general effects on metabolism, water and elec olyte imbalance: (b) negative feedback effect onthe hypothalamus and pituitary lands; (c)ant-ifammatory and immunosuppressive effects. thas negigible socium-relaning Propetis and has powerful antiinflammatory and immunosuporessive eects. Pharmacokinetics Dexamethasone is well absorbed oraly. Peak plasma lavels are reached between 1 to 2 hous ater ingestion. The area under the curve (AUC), volume af dstibtion, plasma clearance, and maximum plasma concentration are not dose-dependent but vary by a factor of about 0.6-07 ater oral doses of 0.6-1.5 mg. The systemic bioavailability of dexamethasone is approximately 90% and the mean plasma halife is 3.6 + 0.9 hours. Upto 77% of dexamethasone is bound to plasma proteins. Percentage binding of dexamethasone, unlke that of cortsal, remains practcally unchanged wih increasing steroid concentrations. ‘Dexamethasone's metabolism inthe lver is sow and lnited and 60% ofthe administered dose is excreted in the urine within 24 hour largely as unconjugated steroids, Dexamethasone's plasma hattife is shortened in chronic renal falure. Metabolic clearance is reduced and plasma half is prolonged n patents with ver disease. Dexamethasone fs cleared mare rapidly rom the culation of the fetus and neonate than inthe mathe. INDICATIONS Cerebral Edema Cerebral edema associated wih primary or metastatic brain tumor, craniotomy or head injury. Use in cerebral edema is nol a substitute for careful neurosurgical evaluation and defrive management such as neurosurgery a other spectc therapy. Endocrine Disorders Congenital adrenal hyperplasia Primary or secondary adrenocortical nsuflency hydrocortisone or cortisone isthe Norsuppuratve tyres "st choice; sythaic analogs tke dexamanarone may bo Used in canunction with Fypoealomia associates wih cancer mintalcorcids whee appceble in lery, mreraecoriadsuplemeniaton Merge stots ‘ot paricularimportancs) Control of severe incapacitating allergic conctons intractable to adequae trials of conventional treatment in adults and children with Bronchial asthma Seasonal or perennial argc thins Contac dermatitis Alopic derma Serum sickness Drug hypersensitivity reactions Rheumatic Disorders |As adjunctive therapy for short-term administration (ote the patent over an acute episode or exacerbation) in Posttraumatic ostecartniis ‘Synoviis of osteoarthits Rheumatoid aris, including juvenile cheumatod artis ‘Ankylosing spondyitis (selected casos may require low-dose maintenance therapy) ‘Acute and subacute bursts Acute nonspecific tenosynovitis ‘cute gouty arthrits ‘cute rheumatic carts Psoriatic arts icondyits Dermatomyositis, polymyosits Collagen Diseases During an exacerbation or as maintenance thrapy in selected cases of: ‘Systomic lupus erythematosus Acute rheumatic cars Anterts Dormatologie Diseases Pemphigus Bullous dermatitis herpetiformis ‘Severe erythema multiforme (Stevens-Johnson syndrome} Exfotive demas [Mycosis fungoides Severe seborheic dermatits ‘Severe psoriasis Ophthalmic Diseases ‘Severe acute and chronic allergic and inflammatory processes involving the eye and is adnexa, such as Herpes zoster ophtralmicus Ins, itdocyits Chotoctinits Diffuse posterior wets and choroctis Optic neurits ‘Sympathetic ophthalmia, Ataror segment infammation ‘Allergic conjuncivits Kerattis ‘Allergic comeal marginal ulcers Retinopathy Respiratory Diseases ‘Symplomatc sarcoidosis. Benjlosis Fulminating or disseminated pulmonary tuberculosis when used concurenty _ldlopathc eosinophile pneumonias wit appropriate antituberculous chematherapy Loafer’ syndrome not manageable by other means Aspiration pneumonitis. Prevention of naonatarespiralory cstess syndrome Hematologic Diseases Idiopathic thrombocytopenic purpura in adults Pure red cll aplasia ‘Secondary tombacytopenia in adults Acquired (autoimmune) hemolytic anemia CCongental(eytheoia) hypoplastic anemia (Diamond-Blacan anemia) ‘Nooplastc Diseases For paliatve management of leukemia and lymphomas n adits ‘Acute lukemiain ciaren Chemotherapy - Induced Nausea and Vomiting Edematous Statos To induce diuresis orremission of proteinuria in nephrotic syndrome, without uremia, ofthe idiopathic ype, or that due to lupus erythematosus Gastrointestinal Diseases ‘Tote the pation over acral period ofthe cisease in: Ulcerative coits Regional enteritis Other Uses “Tuberculous meningitis with subarachnoid block orimpencing block when used Acute exacerbations of multiple sclerosis, concurently wth appropriate antituberculous chemotherapy TTrchnos's with neuroigic of myocar involvement Diagnostic testing of adrenocortical hypertunction DOSAGE AND ADMINISTRATION INDIVIDUALIZE DEXAMETHASONE DOSE BASED ON THE CONDITION BEING TREATED AND THE RESPONSE OF THE PATIENT. Initial Oral Adult Dose: Varies from 0.75 mg 750 meg) to 9mg a day depending on the type and saver af he disease being Veated Initial Oral Pediatric Dose: Varies ftom 0.02 to 0.3mg/kg body weight per day 0.6 to 9 mg/m’ body surface arealday) depencing onthe ype and sever ofthe dsease being treated given in thee or four vided doses, Maintain andlor adjust inital dosage unl a satisfactory response is noted, Discontinue dexamethasone and shit the patent to oter appropriate therapy cinical response is satay. ‘Signs that may require dosage adjustment include changes in cinial status resulting from remissions or exacerbations ofthe disease, individual drug responsiveness, and sitess which maybe attributed io suger, infection or trauma, Intimes of stress (e.g, surgery, infection or trauma) temporary increasing cortcosteroid dose in patients with tna insuiency maybe nessa pen ebanng a stacy response, decease dose in smal neers unl the west ve iat mars an adequate lca responses reached. Gradually withdraw dexamethasone when sopping reatment atrlon ‘erm therapy {mare than 3 weeks) since significant adrenal suppression's expected to occurin patients reoshing coriostecs former than 3 weeks. ‘Treatment of Acute Exacerbations of Multiple Sclerosis: Usual Recommended Oral Dexamethasone Dose: 30 mg dail fora week, then 4o 12mg every ther day for month, Treatment of Acute, Solf.Limited Allergic Disorders or Acute Exacorbations of Chronic Disorders: Day’: 48mg dexamethasone sodium phosphate injection given Mt Days 2&3: 3mgotal dexamethasone in two dvided doses Day4: 1.5mgoral dexamethasone in two divided doses Days 5 &6: 0.75 mg (750 meg) ora dexamethasone once daly Then the drugis ciscontinued ‘Treatment of Cerebral Edema Dexamethasone sodium phosphate njecionis general administered intaly uni symptoms of cerebral edema subside \When possible, oral dexamethasone 1-3 mg three times dally should replace parenteral dexamethasone, ‘Teatnent of Chemotherapy induced Nausea and Vong ‘Chemotherapy Regimen with High ‘Chemotherapy Regimen wih Moderate ‘ematerapy Regimen wih Low “*Emotic Risk (>90%) “*Emetic Risk (30 ~ 90 %) “*Emetic Risk (10 - 30%) Includes IV atncoplastc agent such as: cspatn, | ures aS a ae amide, | lelues IV antneoplast agents such as: paclor

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