Atripla contains a combination of efavirenz, emtricitabine, and tenofovir. Efavirenz, emtricitabine, and tenofovir are antiviral medications that prevent human immunodeficiency virus (HIV) from reproducing in your body.

Atripla is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Atripla is for use in adults and children who are at least 12 years old and weigh at least 88 pounds (40 kilograms).

Do not take Atripla together with adefovir, atazanavir, voriconazole, or medications that contain emtricitabine, lamivudine, or tenofovir.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Atripla can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as stomach pain or swelling, loss of appetite, dark urine, or yellowing of your skin or eyes.

Atripla may cause a serious condition called lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

If you've ever had hepatitis B, it may become active or get worse after you stop using Atripla. You may need frequent liver function tests for several months.

Take Atripla exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take this medicine on an empty stomach with a full glass of water.

You will need frequent medical tests.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use efavirenz, emtricitabine, and tenofovir.

Store Atripla in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Atripla. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose of Atripla for HIV Infection:

1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Adult Dose of Atripla for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-The components of this drug are recommended as a preferred NNRTI-based regimen for nonoccupational postexposure prophylaxis of HIV infection.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose of Atripla for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

You should not take Atripla if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).

Do not take Atripla together with adefovir, atazanavir, voriconazole, or any medications that contain emtricitabine, lamivudine, or tenofovir (such as Combivir, Complera, Descovy, Epivir, Epzicom, Genvoya, Odefsey, Stribild, Trizivir, Truvada, Vemlidy).

To make sure Atripla is safe for you, tell your doctor if you have:

• liver or kidney disease;

• long QT syndrome;

• mental illness, use of antipsychotic medication, or injection drug use;

• epilepsy or other seizure disorder;

• low bone mineral density; or

• hepatitis B or C infection.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Efavirenz, emtricitabine, and tenofovir can cause birth defects. Do not use Atripla if you are pregnant, and do not get pregnant for at least 12 weeks after you stop taking this medicine.

Atripla can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Atripla, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include uncontrolled muscle movements.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Atripla (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations;

• a seizure (convulsions);

• kidney problems - increased thirst and urination, muscle pain or weakness; or

• liver problems - swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Atripla affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Atripla side effects may include:

• dizziness, drowsiness, tired feeling;

• nausea, diarrhea;

• headache, depressed mood, trouble concentrating;

• sleep problems (insomnia), strange dreams;

• rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Atripla can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your current medicines. Many drugs can interact with efavirenz, emtricitabine, and tenofovir, especially:

• St. John's wort;

• an antibiotic or antifungal medicine;

• an antidepressant;

• any other HIV medicines;

• cholesterol medication;

• heart or blood pressure medication;

• medicine to prevent organ transplant rejection;

• medicine to treat hepatitis;

• seizure medicine; or

• tuberculosis medication.

This list is not complete. Many drugs can interact with efavirenz, emtricitabine, and tenofovir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.