Tecavir Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Entecavir

Indications/Uses

Chronic HBV infection in adults w/ evidence of acute viral replication & continuous increase in serum ALT or AST or histologically active disease.

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Dosage/Direction for Use

Compensated liver disease 0.5 mg once daily. Decompensated liver disease 1 mg once daily. Renal impairment CrCl 30-<50 mL/min 0.5 mg every 48 hr. Lamivudine-refractory or decompensated liver disease: 1 mg every 48 hr; 10-<30 mL/min 0.5 mg every 72 hr. Lamivudine-refractory or decompensated liver disease: 1 mg every 72 hr; <10 mL/min, on hemodialyis or continuous ambulatory peritoneal dialysis (CAPD) 0.5 mg every 7 days. Lamivudine-refractory or decompensated liver disease: 1 mg every 7 days.

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Administration

May be taken with or without food: For patients w/ decompensated liver disease & lamivudine-refractory patients w/ compensated liver disease, take 2 hr before or 2 hr after meals. In nucleoside naive patients w/ compensated liver disease, may administer w/ meals if necessary.

Contraindications

Hypersensitivity.

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Special Precautions

Lactic acidosis & severe hepatomegaly w/ steatosis; patients w/ risk factors for liver disease. Acute exacerbations of severe hepatitis B in patients who have discontinued therapy. Not recommended for HIV & HBV co-infected patients who are not receiving highly active antiretroviral therapy (HAART). Monitor renal function before & during therapy in liver transplant recipients receiving immunosuppresants eg, cyclosporine or tacrolimus.

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Adverse Reactions

Diarrhea, dyspepsia, nausea, vomiting; fatigue; headache, dizziness, decreased consciousness; insomnia.

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Drug Interactions

Increased serum conc w/ drugs known to reduce kidney function or compete for tubular secretions.

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Description

View Tecavir description for details of the chemical structure and excipients (inactive components).

MIMS Class

Antivirals

ATC Classification

J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

Regulatory Classification

Presentation/Packing

Form

Tecavir FC tab 0.5 mg

Packing/Price

3 × 10's

Form

Tecavir FC tab 1 mg

Packing/Price

3 × 10's

Tecavir

entecavir

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo