Y.S.P. Industries


Y.S.P. Industries
Concise Prescribing Info
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.
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. Renal impairment CrCl 30 to <50 mL/min 0.5 mg every 48 hr, 10 to <30 mL/min 0.5 mg every 72 hr, <10 mL/min, haemodialysis or continuous ambulatory peritoneal dialysis (CAPD) 0.5 mg every 5-7 days.
Should be taken on an empty stomach: For patients w/ decompensated liver disease & lamivudine-refractory patients w/ compensated liver disease, take 2 hr before or after meals. In nucleoside-naive patients w/ compensated liver disease, may administer w/ meals if necessary.
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 to be used to reduce risk of HBV transmission. Not recommended for HIV infection. Lactic acidosis associated w/ severe hepatomegaly & hepatic steatosis; known risk factors of liver disease; pancreatitis; higher levels of serum lactate; pre-existing lamivudine-resistant HBV. Co-infection w/ hepatitis C or D;  HIV w/ low CD4 cell counts (<200 cells/mm3). Monitor hepatic function at repeated intervals for at least 6 mth after last dose. Frequently monitor virological response & perform resistance testing in lamivudine-refractory patients. Not to be used in galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Advance hepatic disease or cirrhosis; hepatitis exacerbation; Child-Turcotte-Pugh class C disease; liver transplant recipients. Renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Ped & adolescents <16 yr.
Adverse Reactions
Insomnia; headache, dizziness, somnolence; vomiting, diarrhoea, nausea, dyspepsia; increased transaminases; fatigue.
Drug Interactions
Increased serum conc w/ medicinal products 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.
Hebecavir FC tab 0.5 mg
3 × 10's
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