tenofovir disoproxil fumarate tablet coated
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. Tenofovir disoproxil fumarate tablets are 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. ( 1 ) Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. ( 1 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are 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. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection: Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ®, COMPLERA ®, DESCOVY ®, GENVOYA ®, ODEFSEY ®, STRIBILD ®, TRUVADA ®, or VEMLIDY ® [See Warnings and Precautions (5.4)] .Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ®, COMPLERA ®, DESCOVY ®, GENVOYA ®, ODEFSEY ®, STRIBILD ®, TRUVADA ®, or VEMLIDY ® [See Warnings and Precautions (5.4)] . 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older . The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HBV infection: The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (14.2) ]. Tenofovir disoproxil fumarate tablets were evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease [See Adverse Reactions (6.1) , Clinical Studies (14.2) ] . The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (12.4) , Clinical Studies (14.2) ].
apotex corp.
TEAR BLUE 32
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16 HOW SUPPLIED/STORAGE AND HANDLING Tenofovir disoproxil fumarate tablets, 300 mg, are almond-shaped, blue, film-coated tablets containing 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil, and are debossed with "32" on one side. Each bottle contains 30 tablets and a desiccant (silica gel canister or sachet), and closed with a child-resistant closure (NDC 60505-4666-3). Store tenofovir disoproxil fumarate tablets at 25 °C (77 °F), excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.
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