TECAVIR 0.5

Therapeutic Class

Antivirals

Indications

Tecavir is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease, evidence of viral replication and histologically documented active liver inflammation or fibrosis. It is also effective in decompensated cirrhosis.

Chemical Composition

Entecavir INN 0.5 mg

Packaging

1 x 10's / Box

Dosage & Administration

Administration of Tecavir with food decreases absorption and so it should be taken in an empty stomach (at least 2 hours before or 2 hours after meal). Adult over 16 years, not previously treated with nucleoside analogues: 0.5 mg once daily. Adult over 16 years with lamivudine or telbivudine resistant chronic hepatitis B: 1 mg once daily. Dose adjustment in renal impairment: Dose adjustment is recommended for patients with creatinine clearance <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown in the following table. Dosing interval adjustment of Tecavir in patients with renal impairment Creatinine clearance (ml/min) ≥50 30 to <50 10 to <30 <10 Hemodialysis or CAPD Recommended dose 0.5 mg every 24 hours 0.5 mg every 48 hours 0.5 mg every 72 hours 0.5 mg every 7 days

Contraindications

Entecavir is contraindicated to the patients who have hypersensitivity to any component of this product.

Side Effects

The most common side effects are headache, fatigue, dizziness and nausea.

Drug Interaction

Since Entecavir is predominantly eliminated by the kidney, coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either drug.