ALMACAVIR (ENTECAVIR) FILM COATED TABLETS 0.5MG

TABLET, FILM COATED

**\[DOSAGE AND ADMINISTRATION\]** Recommended Dosage Compensated Liver Disease The recommended dose of 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 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 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. 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.  Hepatic Impairment No dosage adjustment is necessary for patients with hepatic impairment. Duration of Therapy The optimal duration of treatment with 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.