emtricitabine 200 mg tenofovir disoproxil fumarate 300 mg tablet film coated
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ): Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and 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. 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) ] .
mylan pharmaceuticals inc.
OVAL GREEN M ET23
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16 HOW SUPPLIED/STORAGE AND HANDLING
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Tablets are available containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. The 200 mg/300 mg tablets are light green, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and ET 23 on the other side. They are available as follows: NDC 0378-1930-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] • Keep container tightly closed. • Dispense only in original container. PHARMACIST: Dispense a Medication Guide with each prescription.
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