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 )

breckenridge pharmaceutical, inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug abuse` `[4] death` `[5] overdose` `[6] fatigue` `[7] nausea` `[8] dyspnoea` `[9] intentional overdose` `[10] chronic kidney disease`

4 years ago

TRIANGLE PINK A 89

16. HOW SUPPLIED/STORAGE AND HANDLING

ENTECAVIR Tablets, USP are available in the following strengths and configurations of plastic bottles with child-resistant closures: Product Strength and Dosage Form Description Quantity NDC Number 0.5 mg film-coated tablet white triangular shaped film coated tablets debossed 'A' on one side and '88' on other side. 30 tablets 90 tablets 51991-895-33 51991-895-90 1 mg film-coated tablet pink triangular shaped film coated tablets debossed 'A' on one side and '89' on other side. 30 tablets 51991-896-33 Storage

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

ENTECAVIR tablets in a tightly closed container and keep out of the light.

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entecavir 0.5 MG Oral Tablet

breckenridge pharmaceutical, inc.

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