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Usual Dosing (Adults)

INDICATIONS AND USAGE
BARACLUDE is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

DOSAGE AND ADMINISTRATION
Nucleoside-treatment-naïve with compensated liver disease (≥16 years old): 0.5 mg once daily.
Lamivudine-refractory or known lamivudine or telbivudine resistance mutations (≥16 years old): 1 mg once daily.

Decompensated liver disease (adults): 1 mg once daily.

Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min.

BARACLUDE should be administered on an empty stomach.

Renal Dosing

dialysis [CRCL > 50 ml/min]: No changes

[30-49 ml/min]: Administer 50% of usual dose

[10-29 ml/min]:  Administer 30% of usual dose

[<10 ml/min]:  (including dialysis): Administer 10% of usual dose; administer after hemodialysis

Hemodialysis

dialysis Administer 10% of usual dose  (administer after hemodialysis)

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.
Entecavir