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Entegard

Entegard

entecavir

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals
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.
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.
Administration
May be taken with or without food.
Contraindications
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.
Adverse Reactions
Headache, fatigue, dizziness, & nausea. Lactic acidosis usually associated w/ severe hepatomegaly & steatosis.
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.
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.
Presentation/Packing
Form
Entegard FC tab 500 mcg
Packing/Price
30's
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