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TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use
It is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors.
It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Treatment of HIV-1 Infection
Recommended dose in adults and pediatric patients (12 years of age and older and weighing greater than or equal to 35 kg): One tablet once daily taken orally with or without food.
Recommended dose in renally impaired HIV-1 infected adult patients: Creatinine clearance 30-49 ml/min: 1 tablet every 48 hours. Circle below 30 ml/min or hemodialysis: Do not use TRUVADA.
Recommended dose in HIV-1 uninfected adults: One tablet once daily taken orally with or without food.
Recommended dose in renally impaired HIV-uninfected individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess the potential risks and benefits of continued use.
In HIV1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and weight decreased.
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-445-3235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Active Ingredient Emtricitabine 200mg & Tenofovir disoproxil fumarate 300mg