📋 Indications & Clinical 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 & Warnings
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.
🔄 Drug Interactions
Drugs that reduce renal function or compete for active tubular secretion.
⚠️ Adverse Reactions / 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.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Avoid, use only when no safer alternative exists for a serious problem
Lactation / Breastfeeding:
Contraindicated
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.