Entecavir Sandoz

Entecavir Sandoz





Concise Prescribing Info
Chronic HBV infection in adults w/ evidence of active viral replication & either evidence of persistent elevations in serum aminotransferases (ALT/AST) or histologically active disease.
Dosage/Direction for Use
Compensated liver disease Nucleoside-naive patient 0.5 mg once daily. Lamivudine-refractory patient 1 mg once daily. Decompensated liver disease 1 mg once daily.
Should be taken on an empty stomach: In nucleoside naive patients w/ compensated liver disease, take w/ or w/o meals. For patients w/ decompensated liver disease & lamivudine-refractory patients w/ compensated liver disease, take on an empty stomach (at least 2 hr before & at least 2 hr after a meal).
Special Precautions
Discontinue use if rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur. Not to be used for HIV/HBV co-infected patients not receiving highly active antiretroviral therapy. Not recommended for HIV infection. Lactic acidosis associated w/ severe hepatomegaly & hepatic steatosis. Patients w/ decompensated liver disease w/ Child-Pugh class C disease. Patients w/ lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients w/o lamivudine resistance. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Closely monitor clinical & lab parameters in patients w/ decompensated liver disease. Frequently monitor virological response for lamivudine-refractory patients. Monitor hepatic function at repeated intervals w/ clinical & lab follow-up for at least 6 mth after discontinuation of therapy. Evaluate renal function prior to & during therapy in liver transplant recipients receiving cyclosporine or tacrolimus. May affect ability to drive & use machines. Renal impairment. Patients w/ advanced liver disease or cirrhosis; hepatomegaly, hepatitis or other known risk factors for hepatic disease; liver transplant recipients. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Childn <16 yr.
Adverse Reactions
Insomnia; headache, dizziness, somnolence; vomiting, diarrhoea, nausea, dyspepsia; increased transaminases; fatigue.
Drug Interactions
Increased serum conc w/ drugs reducing renal function or competing for active tubular secretion.
MIMS Class
ATC Classification
J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Entecavir Sandoz FC tab 0.5 mg
3 × 10's
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