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.
[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
Administer 10% of usual dose (administer after hemodialysis)
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.
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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