entecavir 1 MG Oral Tablet

1 INDICATIONS AND USAGE Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 )

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] nausea` `[4] dyspnoea` `[5] diarrhoea` `[6] pain` `[7] headache` `[8] off label use` `[9] dizziness` `[10] vomiting`

4 years ago

OVAL PINK AN 449

16 HOW SUPPLIED/STORAGE AND HANDLING

ENTECAVIR tablets, USP 0.5 mg, are supplied as white to off-white, oval, film-coated, biconvex bevel edged, unscored tablet, debossed with “AN” on one side and “446” on the other side. They are available as follows: Bottles of 30: NDC 65162-446-03 Bottles of 90: NDC 65162-446-09

ENTECAVIR tablets, USP 1 mg, are supplied as pink, oval, film-coated, biconvex bevel edged, unscored tablet, debossed with “AN” on one side and “449” on the other side. They are available as follows: Bottles of 30: NDC 65162-449-03 Storage

ENTECAVIR tablets, USP should be stored in a tightly closed container at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

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entecavir 0.5 MG Oral Tablet

Amneal Pharmaceuticals LLC

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