Generic name: entecavir
Dosage form: tablets, film coated; oral solution
This dosage information does not include all the information needed to use Baraclude safely and effectively. See full prescribing information for Baraclude.
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BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
2.1 Recommended Dosage
Compensated Liver Disease
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.
The recommended dose of BARACLUDE in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance mutations rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
Decompensated Liver Disease
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.
2.2 Renal Impairment
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 1. The once-daily dosing regimens are preferred.
|Usual Dose (0.5 mg)||Lamivudine-Refractory or
Decompensated Liver Disease (1 mg)
|a For doses less than 0.5 mg, BARACLUDE Oral Solution is recommended.
b If administered on a hemodialysis day, administer BARACLUDE after the hemodialysis session.
|≥50||0.5 mg once daily||1 mg once daily|
|30 to <50||0.25 mg once dailya
0.5 mg every 48 hours
|0.5 mg once daily
1 mg every 48 hours
|10 to <30||0.15 mg once dailya
0.5 mg every 72 hours
|0.3 mg once dailya
1 mg every 72 hours
Hemodialysisb or CAPD
|0.05 mg once dailya
0.5 mg every 7 days
|0.1 mg once dailya
1 mg every 7 days