emtricitabine and tenofovir disoproxil fumarate tablet film coated
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ): Emtricitabine and tenofovir disoproxil fumarate tablet is a 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) ] .
amneal pharmaceuticals ny llc
OVAL WHITE AC53
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Amneal Pharmaceuticals NY LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablets are available in bottles containing 30 tablets with child-resistant closure as follows:
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Tablets, 200 mg/300 mg are supplied as white to off-white, capsule shaped, film-coated tablets, debossed on one side with “AC24” and plain on other side. Each tablet contains 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 245 mg of tenofovir disoproxil). They are available as follows: Bottles of 30: NDC 60219-2095-3 Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Keep container tightly closed. Dispense only in original container.
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