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Rebetol Capsules

Rebetol  Capsules
Rebetol Capsules
Product Code : rib
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Product Description

Ribavin  Capsules

DESCRIPTIONREBETOL®REBETOL is Schering Corporation’s brand name for ribavirin, a nucleoside analog. Thechemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and hasthe following structural formula:ONNNONH2HOOH OH Ribavirin is a white, crystalline powder. It is freely soluble in water and slightlysoluble in anhydrous alcohol. The empirical formula is C8H12N4O5 and the molecular weightis 244.21. REBETOL Capsules consist of a white powder in a white, opaque, gelatin capsule.Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystallinecellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. Thecapsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide.The capsule is printed with edible blue pharmaceutical ink which is made of shellac,anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammoniumhydroxide, and FD&C Blue #2 aluminum lake. Mechanism of ActionThe mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy withinterferon products has not been established.CLINICAL PHARMACOLOGYPharmacokineticsRibavirin Single- and multiple-dose pharmacokinetic properties in adults with chronichepatitis C are summarized in TABLE 1. Ribavirin was rapidly and extensively absorbedfollowing oral administration. However, due to first-pass metabolism, the absolutebioavailability averaged 64% (44%). There was a linear relationship between dose andAUCtf (AUC from time zero to last measurable concentration) following single doses of 200-1200 mg ribavirin. The relationship between dose and Cmax was curvilinear, tending toasymptote above single doses of 400-600 mg.Upon multiple oral dosing, based on AUC12hr, a sixfold accumulation of ribavirinwas observed in plasma. Following oral dosing with 600 mg BID, steady-state was reachedby approximately 4 weeks, with mean steady-state plasma concentrations of 2200 (37%)ng/mL. Upon discontinuation of dosing, the mean half-life was 298 (30%) hours, whichprobably reflects slow elimination from nonplasma compartments.Effect of Food on Absorption of Ribavirin Both AUCtf and Cmax increased by 70% whenREBETOL Capsules were administered with a high-fat meal (841 kcal, 53.8 g fat, 31.6 gprotein, and 57.4 g carbohydrate) in a single-dose pharmacokinetic study. There areinsufficient data to address the clinical relevance of these results. Clinical efficacy studieswith REBETOL/INTRON A were conducted without instructions with respect to foodconsumption. During clinical studies with REBETOL/PEG-INTRON, all subjects wereinstructed to take REBETOL Capsules with food. (See DOSAGE ANDADMINISTRATION.)Effect of Antacid on Absorption of Ribavirin Coadministration with an antacid containingmagnesium, aluminum, and simethicone (Mylanta1) resulted in a 14% decrease in meanribavirin AUCtf. The clinical relevance of results from this single-dose study is unknown. 

Generic Rebetol

Indian brand

Ribavin  Capsules

Generic Formula








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