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Composition:
Tecavir-0.5 Tablet: Each film coated tablet contains Entecavir Monohydrate INN equivalent to Entecavir 0.5 mg.
Tecavir-1 Tablet: Each film coated tablet contains Entecavir Monohydrate INN equivalent to Entecavir 1 mg.
Pharmacology:
Entecavir is a guanosine nucleoside analogue with potent and selective activity against HBV polymerase. For pharmacological action it is phosphorylated to the active triphosphate (TP) form. Entecavir triphosphate functionally inhibits all 3 activities of the viral polymerase; (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
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.
Dosage and 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 |
Side effects:
The most common side effects are headache, fatigue, dizziness and nausea.
Precautions:
Monitor liver function tests every 3 months, and viral and serological markers for hepatitis B every 3-6 months. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
Contraindications:
Entecavir is contraindicated to the patients who have hypersensitivity to any component of this product.
Drug interactions:
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.
Use in special group:
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: It is not known whether Entecavir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking Entecavir.
Pediatric use: Safety and effectiveness of Entecavir in pediatric patients below the age of 16 years have not been established.
Geriatric use: Entecavir is significantly excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Storage:
Store in a cool and dry place, protect from light. Keep out of the reach of the children.
Packing:
Tecavir-0.5 Tablet: Box containing 10's tablets in alu-alu blister pack.
Tecavir-1 Tablet: Box containing 10’s tablets in alu-alu blister pack.
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