Manufacturer:

          Bristol-Myers Squibb

Contents:

          Entecavir

Indications:

          Treatment of chronic HBV infection in adults w/ evidence of active viral replication & either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease: Nucleoside-treatment-naive & lamivudine-resistant adult subjects w/ HBeAg-+ve or -ve chronic HBV infection & compensated liver disease; adult subjects w/ chronic HBV infection & decompensated liver disease; adult subjects w/ HIV/HBV co-infection who have received prior lamivudine therapy.

Contraindications:

          Hypersensitivity to any of the ingredients

Special Precautions:

          Severe acute exacerbations of hepatitis B may occur on treatment discontinuation. Monitor hepatic function closely. HIV/HBV co-infected patients not receiving highly active antiretroviral therapy (HAART). Not established for treatment of HIV infection. Obesity & prolonged nucleoside exposure; liver disease. Suspend treatment in patients who develop lactic acidosis or pronounced hepatotoxicity including hepatomegaly & steatosis. Closely monitor laboratory parameters in patients w/ decompensated liver disease particularly Child-Turcotte-Pugh class C disease. Frequently monitor virological response in lamivudine-refractory population. Combination use of entecavir plus a 2nd antiviral agent should be considered in patients w/ both decompensated liver disease & lamivudine-resistant HBV. Patients w/ CrCl <50 mL/min including those on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Liver transplant recipients. Pregnancy & lactation. Childn <16 yr. Elderly.

Dosage:

          Chronic HBV (Compensated liver disease) Nucleoside treatment-naive adult & adolescent ≥16 yr 0.5 mg once daily. Adult & adolescent ≥16 yr w/ a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations 1 mg once daily. (Decompensated liver disease) Adult 1 mg once daily.

Class:

          Antivirals

Presentation/Packing:

          Baraclude 0.5 mg/1mg x 3 blisters x 10 tabs

Details:

          MyPhuocPharmacy – (08) 62581003