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Atripla

Generic Name: Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate (e FAV e renz, em trye SYE ta been, & ten OF oh vir dye soe PROX il FUE ma rate)
Brand Name: Atripla

  • Hepatitis B has gotten worse when Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop taking this medicine without calling your doctor. Talk with your doctor.
  • This medicine is not approved to treat hepatitis B. Hepatitis B testing needs to be done before taking Atripla. Talk with your doctor.

Uses of Atripla:

  • It is used to treat HIV infection.

What do I need to tell my doctor BEFORE I take Atripla?

For all patients taking this medicine:

  • If you have an allergy to efavirenz, emtricitabine, tenofovir, or any other part of Atripla.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had red, blistered, swollen, or peeling skin after taking efavirenz.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Atripla.
  • If you are taking adefovir.
  • If you are taking another drug that has lamivudine in it.
  • If you are using another drug that has the same drug in it.
  • If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

Children:

  • If your child is younger than 12 years of age. Do not give Atripla to a child younger than 12 years of age.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Atripla with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Atripla?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Bone problems like bone pain, soft bones, and thin bones have happened with Atripla. This may lead to broken bones. You may need to have a test to check your bones. Talk with your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Take calcium and vitamin D as you were told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate).
  • This medicine is not a cure for HIV. Stay under the care of your doctor.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this medicine. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start Atripla.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • This medicine may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your doctor.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with Atripla. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this medicine.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Atripla. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine and for 3 months after care ends.
  • If you get pregnant while taking Atripla or within 3 months after your last dose, call your doctor right away.

How is this medicine (Atripla) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take on an empty stomach.
  • Take with a full glass of water.
  • Taking Atripla at bedtime may help with some side effects.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • It is important that you do not miss or skip a dose of Atripla during treatment.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Bone pain.
  • Muscle pain or weakness.
  • Pain in arms or legs.
  • Seizures.
  • Change in body fat.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Atripla?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Change in color of skin.
  • Feeling tired or weak.
  • This medicine may cause you to have dizziness, sleepiness, trouble sleeping, trouble focusing, or dreams that are not normal. Most of the time, these effects go away after taking this medicine for 2 to 4 weeks. It may help if you take Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) at bedtime. Call your doctor if these effects last, they bother you, or are very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Atripla?

  • Store in the original container at room temperature.
  • Keep lid tightly closed.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Atripla or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Atripla. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: November 1, 2017

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