emtricitabine 200 mg tenofovir disoproxil fumarate 300 mg
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14 )] . 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 )] .
Zydus Pharmaceuticals (USA) Inc.
OVAL WHITE 1367
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16 HOW SUPPLIED/STORAGE AND HANDLING
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablets, 100 mg of FTC and 150 mg of TDF (equivalent to 123 mg of tenofovir disoproxil) are white to off-white-colored, oval-shaped, film-coated tablets, debossed with "1364" on one side and plain on other side and are supplied as follows: NDC 70710-1364-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1364-9 in bottles of 90 tablets with child-resistant closure NDC 70710-1364-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablets, 133 mg of FTC and 200 mg of TDF (equivalent to 163 mg of tenofovir disoproxil) are white to off-white-colored, rectangular-shaped, film-coated tablets, debossed with "1365" on one side and plain on other side and are supplied as follows: NDC 70710-1365-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1365-9 in bottles of 90 tablets with child-resistant closure NDC 70710-1365-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablets, 167 mg of FTC and 250 mg of TDF (equivalent to 204 mg of tenofovir disoproxil) are white to off-white-colored, modified capsule-shaped, film-coated tablets, debossed with "1366" on one side and plain on other side and are supplied as follows: NDC 70710-1366-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1366-9 in bottles of 90 tablets with child-resistant closure NDC 70710-1366-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablets, 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) are white to off-white-colored, capsule-shaped, film-coated tablets, debossed with "1367" on one side and plain on other side and are supplied as follows: NDC 70710-1367-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1367-9 in bottles of 90 tablets with child-resistant closure NDC 70710-1367-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed Dispense only in original container Tablets should be used within 6 weeks after first opening the bottle.
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