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ATRIPLA ACCESS- efavirenz, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated


  1. Patient Information
  2. Who Should Not Take Atripla?do Not Take Atripla If You:
  3. Before Taking Atripla, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. Pregnancy Registry:
  5. How Should I Take Atripla?
  6. What Should I Avoid While Taking Atripla?
  7. Atripla May Cause Serious Side Effects, Including:
  8. What Are The Ingredients Of Atripla?active Ingredients:
  9. Inactive Ingredients:

Patient Information 

Advise the patient to read the approved patient labeling (Patient Information).

Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV

Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued FTC or TDF, and may occur with discontinuation of ATRIPLA.Advise patients not to discontinue ATRIPLA without first informing their healthcare provider. All patients should be tested for HBV infection before or when starting ATRIPLA and those who are infected with HBV need close medical follow-up for several months after stopping ATRIPLA to monitor for exacerbations of hepatitis[
ATRIPLA is a prescription medicine that contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate combined in 1 tablet. ATRIPLA is used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection who weigh at least 88 lbs (40 kg).
It is not known if ATRIPLA is safe and effective for use in children with HIV-1 infection who weigh less than 88 lbs (40 kg).

Who Should Not Take Atripla?do Not Take Atripla If You: 

  • are allergic to efavirenz
  • take the medicine called voriconazole, elbasvir or grazoprevir
Ask your healthcare provider if you are not sure if you take any of these medicines.

Before Taking Atripla, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have liver problems, including hepatitis B or C virus infection
  • have heart problems
  • have or have had mental problems
  • have a history of drug or alcohol abuse
  • have nervous system problems
  • have kidney problems or receive kidney dialysis treatment
  • have bone problems
  • have had seizures or take medicines used to treat seizures
  • are pregnant or plan to become pregnant. ATRIPLA can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ATRIPLA.You should not become pregnant during treatment with ATRIPLA and for 12 weeks after stopping treatment.Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ATRIPLA.
    • Females who are able to become pregnant should use 2 effective forms of birth control (contraception) during treatment with ATRIPLA and for 12 weeks after stopping treatment.
    • A barrier form of birth control should always be used along with another type of birth control. Barrier forms of birth control may include condoms, contraceptive sponges, diaphragm with spermicide, and cervical cap.
    • Birth control methods that contain the hormone progesterone such as birth control pills, injections, vaginal rings, or implants, may not work as well while taking ATRIPLA.
    • Talk to your healthcare provider about birth control methods that may be right for you during treatment with ATRIPLA.

Pregnancy Registry: 

There is a pregnancy registry for women who take ATRIPLA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. ATRIPLA can pass into your breast milk. Do not breastfeed because of the risk of passing HIV-1 to your baby.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
    Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
    ATRIPLA and some medicines may interact with each other causing serious side effects.
    You can ask your healthcare provider or pharmacist for a list of medicines that interact with ATRIPLA. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ATRIPLA with other medicines.

    How Should I Take Atripla? 

    • Take ATRIPLA exactly as your healthcare provider tells you to.
    • If you take ATRIPLA with other medicines used to treat HIV-1, your healthcare provider will tell you what medicines to take and how to take them.
    • Take ATRIPLA 1 time each day on an empty stomach. You should take ATRIPLA at the same time each day.
    • Taking ATRIPLA at bedtime may make some side effects less bothersome.
    • Do not miss a dose of ATRIPLA. Missing a dose lowers the amount of medicine in your blood. Refill your ATRIPLA prescription before you run out of medicine.
    • Do not change your ATRIPLA dose or stop taking ATRIPLA without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with ATRIPLA.
    • If you take too much ATRIPLA, call your healthcare provider or got to the nearest hospital emergency room right away.

    What Should I Avoid While Taking Atripla? 

    • ATRIPLA can cause dizziness, impaired concentration and drowsiness. If you have these symptoms, do not drive a car, use heavy machinery, or do anything that requires you to be alert.
    What are the possible side effects of ATRIPLA?

    Atripla May Cause Serious Side Effects, Including: 

      • Store ATRIPLA below 30 C (86 F).
      • Keep ATRIPLA in its original container and keep the container tightly closed.
      Keep ATRIPLA and all other medicines out of reach of children.General information about the safe and effective use of ATRIPLA.
      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals.

    What Are The Ingredients Of Atripla?active Ingredients: 

    efavirenz, emtricitabine, and tenofovir disoproxil fumarate

    Inactive Ingredients: 

    croscarmellose sodium, hydroxypropyl cellulose, magnesium sterate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
    Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404
    ATRIPLA, EMTRIVA, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
    2018 Gilead Sciences, LLC. All rights reserved.
    21937-GS-019A



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