EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR

(ef AV ir enz, em trye SYE ta been, and ten OF oh vir) Brand: Atripla

What is the most significant information I must know about this medicine?

• Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some another medicines can reason unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you also use: midazolam, pimozide, St. John's wort, triazolam, voriconazole, or an ergot medication (dihydroergotamine, ergonovine, ergotamine, methylergonovine).

• Atripla may reason a serious condition called lactic acidosis. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

• This medicine can also reason severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What is efavirenz, emtricitabine, and tenofovir (Atripla)?

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

• Atripla treats HIV in adults and children who are at least 12 years old. HIV causes acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

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

What must I discuss with my healthcare provider till taking Atripla?

• You must not take this medicine if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).

• Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some medicines can reason unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you are taking any of the next drugs:

· midazolam or triazolam;

· pimozide;

· St. John's wort;

· voriconazole; or

· an ergot medicine--dihydroergotamine, ergonovine, ergotamine, methylergonovine.

This medicine must not be used in children weighing smaller than 88 pounds.

• To create certain Atripla is safety for you, speak your doctor if you have:

· liver or kidney disease;

· a history of mental diseases, use of antipsychotic medicine, or injection drug use;

· epilepsy or another seizure disorder;

· low bone mineral density; or

· hepatitis B or C infection.

• Some people taking Atripla develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver malady, and in people who have taken HIV/AIDS medicine for a long time. Conversation with your doctor about your risk.

• FDA pregnancy category D. Do not use this medicine if you are pregnant. It could harm the unborn child. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medicine and for at least 12 weeks after your treatment ends.

• HIV can be passed to your child if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

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

How must I take Atripla?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Take this medicine on an empty stomach at bedtime.

• While using Atripla, you may need frequent blood trials. Your liver function may also need to be tested.

• This medicine can reason you to have a false positive drug screening test. If you provide a urine sample for drug screening, speak the laboratory staff that you are taking Atripla.

• Use this medicine regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• Store in the original container at room temperature, away from moisture, heat, and easy. Hold the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using Atripla.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking Atripla?

• This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medicine will not prevent you from passing HIV to another people. Do not have unprotected sex or share razors or toothbrushes. Conversation with your doctor about safety ways to prevent HIV transmission during sex. Sharing drug or medication needles is never safety, even for a healthy person.

What are the possible side effects of Atripla?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

• Stop using Atripla and call your doctor at once if you have:

· kidney problems--increased thirst and urination, loss of appetite, constipation, few or no urinating; or

· sore throat, flu symptoms, light bruising or unusual bleeding;

· liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

· unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations, seizure (convulsions); or

· severe skin reaction -- fever, sore throat, swelling in your person or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the person or upper body) and causes blistering and peeling.

• Atripla may magnify your risk of determined infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Atripla. Speak your doctor if you have:

· signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

· chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

· cool sores, sores on your genital or anal area;

· rapid heart course, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

· trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

· swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

• General side effects may include:

· mild nausea;

· mild depression;;

· headache, dizziness, weary feeling, strange dreams; or

· changes in the shape or location of body thick (especially in your arms, legs, person, 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 message side effects to FDA at 1-800-FDA-1088.

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

This medication can harm your kidneys. This effect is heighten when you also use determined another medicines, including: antivirals, chemotherapy, injected antibiotics, medication for bowel disorders, medication to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

• Much drugs can interact with Atripla. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with Atripla, especially:

· a blood thinner--clopidogrel; any another HIV medicines--especially atazanavir, didanosine, efavirenz, lopinavir with ritonavir, or tenofovir.

This list is not complete and much another drugs can interact with Atripla. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about efavirenz, emtricitabine, and tenofovir (Atripla)

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

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