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TECARALL

ENTECAVIR · by NIMRALL

ANTIVIRALS FOR SYSTEMIC USE Anti-cytomegalovirus agent NIMRALL

Composition

Tab 0.5 mg/1 mg: Entecavir 0.5 mg/1 mg.

Indications & Dosage

Chronic hepatitis B in patients with compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis): Adult: 500 mcg once daily for patients not previously treated with nucleoside analogues; or 1 mg once daily for patients lamivudine-resistance, consider other treatment if inadequate response after 6 months. Chronic hepatitis B in patients with decompensated liver disease: Adult: 1 mg once daily, at least 2 hour before or after a meal.

Precautions

HIV infection; risk of HIV resistance in patients not receiving highly active antiretroviral therapy, lamivudine-resistant chronic hepatitis B; risk of entecavir resistance Patients (particularly obese women) with hepatomegaly, hepatitis, other risk factors of liver disease; risk of lactic acidosis, sometimes fatal. Discontinue if deterioration in liver function, hepaticsteatosis, progressive hepatomegaly or unexplained lacticacidosis.Co-infection with hepatitis C or D or HIV, elderly, renal impairment; monitor patients regularly for hepatitis B, biochemical, virological and serological markers to determine treatment duration, Cirrhosis; monitor closely for hepatic decompensation. Monitor patients closely for several months after stopping therapy for acute exacerbations of hepatitis.

Interactions

Drugs that reduce renal function or compete for active tubular secretion.

Pregnancy

Avoid, use only when no safer alternative exists for a serious problem

Lactation

Contraindicated

Side Effects

Diarrhoea, dizziness, dyspepsia, fatigue, headache, nausea, raised serum amylase, raised serum lipase, sleep disturbances, vomiting, alopecia, rash, thrombocytopenia, in-somnia, raised ALT, exacerbations of hepatitis.