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Entecavir 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.
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-
- Priming of the HBV polymerase,
- Reverse transcription of the negative strand from the pregenomic messenger RNA
- Synthesis of the positive strand HBV DNA.
Dosage & Administration
Administration of Entecavir 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.
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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.
Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
The most common side effects are headache, fatigue, dizziness and nausea.
Pregnancy & Lactation
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.
Precautions & Warnings
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.
Use in Special Populations
Use in pediatric patient: Safety and effectiveness of Entecavir in pediatric patients below the age of 16 years have not been established.
Use in geriatric patient: 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.
Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown in the following table.
CrCl ≥50 ml/min: 0.5 mg every 24 hours
CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
CrCl <10 ml/min or Hemodialysis or CAPD: 0.5 mg every 7 days
There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.
Hepatic viral infections (Hepatitis B)
Store at temperatures not above 30°C.
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