PMS-Entecavir Dosage/Direction for Use

Recommended Dosage: Compensated Liver Disease: The recommended dose of pms-ENTECAVIR 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, with or without food.
The recommended dose of pms-ENTECAVIR in adults and adolescents (≥16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
Decompensated Liver Disease: The recommended dose of pms-ENTECAVIR for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
Renal Impairment: In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Pharmacology: Pharmacokinetics under Actions]. 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. (See Table 10.)

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Hepatic Impairment: No dosage adjustment is necessary for patients with hepatic impairment.
Duration of Therapy: The optimal duration of treatment with pms-ENTECAVIR for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.