Atripla is a combination antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Atripla is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Atripla 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).

Atripla may also be used for purposes not listed in this medication guide.

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.

You may develop 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 Atripla.

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 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 for Nonoccupational Exposure:

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

Comments:
-Only with expert consultation, an alternative regimen for HIV nonoccupational postexposure prophylaxis (nPEP)
-Efavirenz is contraindicated as nPEP in pregnant women; it should be avoided in nPEP regimens during the first trimester and should not be used for women of childbearing potential who might become pregnant during antiretroviral prophylaxis.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose 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:

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 efavirenz, emtricitabine, and tenofovir 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).

Tell your doctor if you have ever had:

• 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.

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

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Avoid driving or hazardous activity until you know how efavirenz, emtricitabine, and tenofovir 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 (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.

Efavirenz, emtricitabine, and tenofovir may cause serious side effects. 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 efavirenz, emtricitabine, and tenofovir). 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 side effects of efavirenz, emtricitabine, and tenofovir 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 affect Atripla, 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 affect Atripla, 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.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking efavirenz, emtricitabine, and tenofovir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of efavirenz, emtricitabine, and tenofovir on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.