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All about: efavirenz, emtricitabine, and tenofovir

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Generic Name: efavirenz, emtricitabine, and tenofovir (ef uh VY renz em tri SYT uh been ten O fo veer)
Brand Names: Atripla

What is efavirenz, emtricitabine, and tenofovir?

Efavirenz, emtricitabine, and tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Efavirenz, emtricitabine, and tenofovir treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Efavirenz, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Efavirenz, emtricitabine, and tenofovir may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about efavirenz, emtricitabine, and tenofovir?

There are many other medicines that can cause interactions or serious medical problems if you take them together with efavirenz, emtricitabine, and tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Do not use this medication if you are taking astemizole (Hismanal), cisapride (Propulsid), midazolam (Versed) or triazolam (Halcion), voriconazole (Vfend), or an ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray). Do not take other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread). Do not take other medicines that contain lamivudine (such as Combivir, Epivir, Epzicom, or Trizivir). This medication may cause lactic acidosis (the build-up of lactic acid in the body). Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heartbeat, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Efavirenz, emtricitabine, and tenofovir can cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

What should I discuss with my healthcare provider before taking efavirenz, emtricitabine, and tenofovir?

Do not use this medication if you are taking any of the following drugs:
  • astemizole (Hismanal);

  • cisapride (Propulsid);

  • lamivudine (Combivir, Epivir, Epzicom, or Trizivir);

  • midazolam (Versed) or triazolam (Halcion);

  • voriconazole (Vfend); or

  • an ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray); or

  • any other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread).

Some of these medicines can cause life-threatening interactions if you take them with efavirenz, emtricitabine, and tenofovir.

Before taking this medication, tell your doctor if you have:
  • liver disease;
  • kidney disease;
  • a history of mental illness, use of antipsychotic medication, or injection drug use;

  • epilepsy or other seizure disorder;

  • bone problems; or

  • hepatitis B (HBV) infection.

If you have any of these conditions, you may not be able to use efavirenz, emtricitabine, and tenofovir, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use the medication without your doctor's consent if you are pregnant. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on a pregnancy patient registry when you start using this medication.

You should not breast-feed while you are using efavirenz, emtricitabine, and tenofovir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

How should I take efavirenz, emtricitabine, and tenofovir?

Take efavirenz, emtricitabine, and tenofovir exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take each dose with a full glass of water. Efavirenz, emtricitabine, and tenofovir should be taken on an empty stomach. Taking the medicine at bedtime may lessen some of the side effects.

It is important to take this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store this medicine at room temperature away from moisture, heat, and direct light. Keep the medicine in its original bottle with the cap tightly closed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an efavirenz, emtricitabine, and tenofovir overdose are not known.

What should I avoid while taking efavirenz, emtricitabine, and tenofovir?

Do not take other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread). Do not take other medicines that contain lamivudine (such as Combivir, Epivir, Epzicom, or Trizivir). Avoid drinking alcohol, which can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by efavirenz, emtricitabine, and tenofovir.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking this medication will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Efavirenz, emtricitabine, and tenofovir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • unusual muscle pain and weakness, trouble breathing, fast or uneven heartbeat, vomiting, and numbness or cold feeling in your arms or legs;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • urinating less than usual or not at all;

  • increased thirst and urination, loss of appetite, weakness, constipation;

  • fever, chills, body aches, flu symptoms;

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

  • a red, blistering, peeling skin rash; or

  • seizure (convulsions).

Other, less serious side effects are more likely to occur, such as:

  • dizziness, drowsiness, anxiety, weakness, ringing in your ears, vision problems;

  • sleep problems (insomnia), confusion, strange dreams, forgetfulness;

  • mild nausea, vomiting, diarrhea, or constipation;

  • darkened skin on the palms of your hands or the soles of your feet;

  • joint or muscle pain;

  • numbness or tingly feeling;

  • runny or stuffy nose, cough; or

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

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect efavirenz, emtricitabine, and tenofovir?

There are many other medicines that can cause interactions or serious medical problems if you take them together with efavirenz, emtricitabine, and tenofovir. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Drugs that can interact with efavirenz, emtricitabine, and tenofovir include:

  • acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);

  • St. John's wort;

  • sertraline (Zoloft);

  • methadone (Methadose);

  • birth control pills;

  • adefovir (Hepsera) or cidofovir (Vistide);

  • a blood thinner such as warfarin (Coumadin);

  • cholesterol medications such as atorvastatin (Lipitor), pravastain (Pravachol), or simvastatin (Zocor);

  • antibiotics such as clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifater, Rifamate);

  • seizure medicines such as carbamazepine (Tegretrol, Carbatrol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton); or

  • certain other HIV medicines such as amprenavir (Agenerase), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept).

If you are using any of these drugs, you may not be able to take efavirenz, emtricitabine, and tenofovir, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect efavirenz, emtricitabine, and tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has more information about efavirenz, emtricitabine, and tenofovir written for health professionals that you may read.

What does my medication look like?

Efavirenz, emtricitabine, and tenofovir is available with a prescription under the brand name Atripla. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Atripla 600 mg /200 m/300 mg (efavirenz, emtricitabine, tenofovir)-pink, capsule-shaped tablets

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 9/20/06 12:45:05 PM.

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