Tablet Manufacturer/Distributor: Beacon Pharmaceuticals Ltd. Generic Name: Entecavir
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Indications of Caviral 0.5 Tablet
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.
Pharmacology of Caviral 0.5 Tablet
Entecavir is a guanosine nucleoside analogue that inhibits HBV polymerase in a strong and specific manner. It is phosphorylated to the active triphosphate (TP) form for pharmacological activity. All three actions of the viral polymerase are functionally inhibited by entecavir triphosphate: priming of the HBV polymerase, reverse transcription of the negative strand from pregenomic messenger RNA, and synthesis of the positive strand of HBV DNA.
Dosage & Administration of Caviral 0.5 Tablet
Administration of Entecavir with food decreases absorption and so it should be taken on an empty stomach (at least 2 hours before or 2 hours after a meal). An adult over 16 years, not previously treated with nucleoside analogs: 0.5 mg once daily. An adult over 16 years with lamivudine or telbivudine-resistant chronic hepatitis B: 1 mg once daily.
Interaction of Caviral 0.5 Tablet
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.
Contraindications
Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
Side Effects of Caviral 0.5 Tablet
The most common side effects are headache, fatigue, dizziness, and nausea.
Pregnancy & Lactation
Use in pregnancy: There are no adequate and well-controlled studies on 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 breastfeed 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 the deterioration in liver function, hepatic steatosis, progressive hepatomegaly, or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
Storage Conditions
Store at temperatures not above 30°C.
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