Tecavir Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Entecavir monohydrate

Indications/Uses

Chronic hepatitis B virus infection; decompensated cirrhosis.

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Dosage/Direction for Use

Adult >16 yr Not previously treated w/ nucleoside analogues: 0.5 mg once daily. Lamivudine or telbivudine resistant chronic hepatitis B: 1 mg once daily. Renal impairment CrCl ≥50 mL/min 0.5 mg 24 hrly. CrCl 30-<50 mL/min 0.5 mg 48 hrly. CrCl 10-<30 mL/min 0.5 mg 72 hrly. CrCl <10 mL/min, hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) 0.5 mg every 7 days.

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Administration

Should be taken on an empty stomach: Take at least 2 hr before or 2 hr after meals.

Contraindications

Hypersensitivity.

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Special Precautions

Monitor liver function tests 3 mthly; viral & serological markers for hepatitis B 3-6 mthly. Discontinue w/ liver function deterioration, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation. Renal impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, fatigue, dizziness & nausea.

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Drug Interactions

Mutual increased serum conc w/ drugs reducing renal function or competing for active tubular secretion.

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Storage

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Description

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

Action

View Tecavir mechanism of action for pharmacodynamics and pharmacokinetics details.

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

POM

Presentation/Packing

Form

Tecavir FC tab 0.5 mg

Packing/Price

1 × 10's

Form

Tecavir FC tab 1 mg

Packing/Price

1 × 10's

Tecavir

entecavir

Manufacturer:

Aristopharma

Distributor:

KTZ