entecavir 0.5 MG Oral Tablet
1 INDICATIONS AND USAGE 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 following points should be considered when initiating therapy with entecavir: • In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease. [see Clinical Studies (14.1) ]. Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude® (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information. Entecavir is a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor 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. (1)
golden state medical supply, inc.
ROUND WHITE 0 5
0 5 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Entecavir tablets USP are available in the following strengths and configurations of bottles with child-resistant closures: Product Strength and Dosage Form Description Quantity NDC Number 0.5 mg film-coated tablet round, white to off-white, coated tablets, debossed with '0.5' on one side and plain on the reverse 30 tablets 51407-064-30 1 mg film-coated tablet round, pink, coated tablets, debossed with '1' on one side and plain on the reverse 30 tablets 51407-065-30 Storage Entecavir tablets USP should be stored in a tightly closed container at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Protect from light.
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