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U.S. Department of Health and Human Services

Safety

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Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Coadministration with Related Products
  • Related drugs not for coadministration with Atripla include Complera (emtricitabine/rilpivirine/tenofovir DF), Emtriva (emtricitabine), Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir DF), Truvada (emtricitabine/tenofovir DF), and Viread (tenofovir DF), which contain the same active components as Atripla…
Rash
  • For patients who have had a life-threatening cutaneous reaction (eg, Stevens-Johnson syndrome), alternative therapy should be considered…
 

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • Emtricitabine - Samples of breast milk obtained from five HIV-1 infected mothers show that emtricitabine is secreted in human milk…