Entecavir(en tek’ ah veer)
Baraclude
PREGNANCY CATEGORY C
Drug Classes
Antiviral
Nucleoside analogue
Therapeutic Actions
Blocks activities of hepatitis B virus reverse transcriptases by competing with a natural substrate and leading to decreased viral load associated with hepatitis B.
Indications
Treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease
Contraindications and Cautions
Contraindicated with known hypersensitivity to entecavir or any of its components, lactation, co-infection with HIV in patients not receiving highly active antiretroviral therapy.
Use cautiously with pregnancy, renal impairment, liver transplant, concurrent use of drugs that alter renal function.
Available Forms
Tablets—0.5, 1 mg; oral solution—0.05 mg/mL
Dosages
Adults and children 16 yr and older with no previous nucleoside treatment
0.5 mg/day PO on an empty stomach at least 2 hr after a meal or 2 hr before the next meal.
Adults and children 16 yr and older with a history of viremia also receiving lamivudine or with known resistance mutations
1 mg/day PO on an empty stomach at least 2 hr after a meal or 2 hr before the next meal.
Pediatric patients younger than 16 yr
Safety and efficacy not established.
Patients with renal impairment
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