Entegard Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage 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

Indications/Uses

Chronic hepatitis B in adults w/ compensated liver disease w/ evidence of active viral replication, persistently elevated liver enzyme values, & histologically active disease including those resistant to lamivudine.

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Dosage/Direction for Use

Nucleoside treatment-naïve patient 500 mcg once daily. Patient w/ history of hepatitis B viraemia during lamivudine therapy or w/ known resistance to lamivudine 1 mg once daily. Nucleoside treatment-naïve patient w/ renal impairment CrCl 30-49 mL/min 250 mcg once daily, CrCl 10-29 mL/min 150 mcg once daily, CrCl <10 mL/min 50 mcg once daily. Lamivudine-refractory patient w/ renal impairment CrCl 30-49 mL/min 500 mcg once daily, CrCl 10-29 mL/min 300 mcg once daily, CrCl <10 mL/min 100 mcg once daily. Patient receiving hemodialysis Give appropriate dose after each dialysis session.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Special Precautions

Reports of severe exacerbation of hepatitis B after stopping treatment. Closely monitor hepatic function w/ both clinical & lab follow-up for several mth after discontinuation. Women of childbearing potential should use effective contraception. Not be used during pregnancy unless clearly necessary. Discontinue breast-feeding during treatment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, fatigue, dizziness, & nausea. Lactic acidosis usually associated w/ severe hepatomegaly & steatosis.

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Drug Interactions

Co-administration w/ medicinal products that reduce renal function or compete for active tubular secretion may increase serum conc of either entecavir or the concomitant medicinal product.

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Storage

View Entegard storage conditions for details to ensure optimal shelf-life.

Description

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

Action

View Entegard 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

Presentation/Packing

Form

Entegard FC tab 500 mcg

Packing/Price

30's

Entegard

entecavir

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals