Land: Singapore
Språk: engelska
Källa: HSA (Health Sciences Authority)
Entecavir Monohydrate equivalent to Entecavir
HETERO SINGAPORE PTE. LTD.
J05AF10
TABLET, FILM COATED
Entecavir Monohydrate equivalent to Entecavir 1.000mg
ORAL
Prescription Only
Hetero Labs Limited
ACTIVE
2023-05-23
Dosage adjustment of Entecavir is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or CAPD [see _Dosage and Administration _and _Clinical _ _Pharmacology_]. RENAL IMPAIRMENT This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease [see _Clinical Studies_]. DOSAGE AND ADMINISTRATION HEPATIC IMPAIRMENT Entecavir is 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. 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. ENTECAVIR is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product. Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see _Warnings and Precautions _ and _Clinical Studies_]. PATIENTS CO-INFECTED WITH HIV AND HBV _DECOMPENSATED LIVER DISEASE_ TECAVIR 0.5 MG AND 1 MG INDICATIONS AND USAGE Entecavir Tablets 0.5 mg and 1 mg RECOMMENDED DOSAGE 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 [see _Clinical Pharmacology_]. Dosage adjustment is recommended for patients with creatinine clearance less Läs hela dokumentet