📋 Indications & Clinical Dosage
*Chronic hepatitis B infection with decompensated liver disease (in combination with another antiviral for chronic hepatitis B), Chronic hepatitis B infection with compensated liver disease with evidence of viral replication, active liver inflammation and fibrosis, when other treatment not appropriate:*
Adult: 10 mg once daily
⚠️ Precautions & Warnings
Patients (particularly obese women) with hepatomegaly, hepatitis, other risk factors of liver disease; risk of lactic acidosis, sometimes fatal, co-infection with hepatitis C or D or HIV, elderly. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lacticacidosis. Monitor patients every 6 months for hepatitis B biochemical, virological and serological markers to determine the treatment duration. Renal impairment; monitor renal function every 3 months. Cirrhosis; monitor closely for hepatic decompensation. Monitor patients closely for several months after stopping therapy for acute exacerbations of hepatitis.
🔄 Drug Interactions
Drugs excreted by or which affect renal tubular excretion.
⚠️ Adverse Reactions / Side Effects
Asthenia, abdominal pain, diarrhoea, dyspepsia, flatulence, headache, hypophosphataemia, nausea, pancreatitis, pruritus, rash, renal failure, vomiting, raised serum creatinine levels, renal insufficiency
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Caution advised, use only if potential benefit outweighs risk
Lactation / Breastfeeding:
Contraindicated, avoid
📚 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.