Tenofovir disoproxil fumarate 300 MG Oral Tablet
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1.1 ) • for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older. Pediatric use information is approved for Gilead Sciences, Inc.'s VIREAD ® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
camber pharmaceuticals, inc.
TEAR WHITE H 123
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16 HOW SUPPLIED/STORAGE AND HANDLING
TENOFOVIR DISOPROXIL FUMARATE Tablets, 300 mg, are white colored, almond shaped, film coated tablets contain 300 mg of
TENOFOVIR DISOPROXIL FUMARATE, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with 'H' on one side and '123' on other side. They are packaged as follows: Bottle of 30 tablets (NDC 31722-535-30) Bottle of 60 tablets (NDC 31722-535-60) Bottle of 100 tablets (NDC 31722-535-01) Bottle of 500 tablets (NDC 31722-535-05) Bottle of 1000 tablets (NDC 31722-535-10) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. • Keep container tightly closed. • Do not use if seal over bottle opening is broken or missing.
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