efavirenz, emtricitabine, and tenofovir
|Pronunciation:||ef AV ir enz, em trye SYE ta been, and ten OF oh vir|
What is the most important information I should know about efavirenz, emtricitabine, and tenofovir?
|Do not use efavirenz, emtricitabine, and tenofovir if you are pregnant. It could harm the unborn baby.|
|Do not take this medication if you are also taking cisapride (Propulsid), midazolam (Versed), triazolam (Halcion), St. John's wort, voriconazole (Vfend), or an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine). Do not take this medication with other medicines that also contain efavirenz, emtricitabine, or tenofovir (Complera, Sustiva, Emtriva, Truvada, Viread), or lamivudine (Combivir, Epivir, Epzicom, Trizivir).|
There are many other drugs that can cause serious or life-threatening medical problems if you take them together with efavirenz, emtricitabine, and tenofovir. Tell your doctor about all medications you use.
|Some people develop lactic acidosis while taking efavirenz, emtricitabine, and tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.|
|Efavirenz, emtricitabine, and tenofovir can cause 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?
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). This medication is not a cure for HIV or AIDS.
Efavirenz, emtricitabine, and tenofovir may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking efavirenz, emtricitabine, and tenofovir?
|You should not take this medication if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread), or if you are taking any of the following drugs:|
- cisapride (Propulsid);
- midazolam (Versed) or triazolam (Halcion);
- St. John's wort;
- voriconazole (Vfend);
- an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine);
- lamivudine (Combivir, Epivir, Epzicom, or Trizivir); or
- any other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Complera, Sustiva, Emtriva, Truvada, or Viread).
To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:
- liver or kidney disease;
- a history of mental illness, use of antipsychotic medication, or injection drug use;
- epilepsy or other seizure disorder;
- osteopenia (low bone mineral density); or
- hepatitis B or C infection.
|FDA pregnancy category D. Do not use this medication if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 12 weeks after your treatment ends.|
HIV can be passed to your baby 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 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.|
|Some people develop a life-threatening condition called lactic acidosis while taking efavirenz, emtricitabine, and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.|
How should I take efavirenz, emtricitabine, and tenofovir?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
|Take this medication on an empty stomach at bedtime.|
Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.
|If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using efavirenz, emtricitabine, and tenofovir.|
This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking efavirenz, emtricitabine, and tenofovir.
HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.
|Store in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.|
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
|Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause uncontrolled muscle movements.|
What should I avoid while taking efavirenz, emtricitabine, and tenofovir?
|Drinking alcohol can increase certain side effects of this medication.|
|This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.|
|Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing 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.|
What are the possible side effects of efavirenz, emtricitabine, and tenofovir?
|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.|
|This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.|
|Stop using this medication and call your doctor at once if you have any other serious side effects such as:|
- signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- urinating less than usual or not at all;
- fever, chills, body aches, flu symptoms;
- unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations;
- severe blistering, peeling, and red skin rash; or
- seizure (convulsions).
Less serious side effects may include:
- mild nausea, vomiting, diarrhea, gas, upset stomach;
- headache, dizziness, drowsiness, tired feeling;
- trouble concentrating;
- sleep problems (insomnia), strange dreams;
- darkened skin on the palms of your hands or the soles of your feet; 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.
What other drugs will affect efavirenz, emtricitabine, and tenofovir?
Many drugs can interact with efavirenz, emtricitabine, and tenofovir. Below is just a partial list. Tell your doctor if you are using:
- acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);
- adefovir (Hepsera) or cidofovir (Vistide);
- maraviroc (Selzentry);
- methadone (Methadose);
- sertraline (Zoloft);
- a blood thinner such as warfarin (Coumadin, Jantoven);
- cholesterol medications such as atorvastatin (Lipitor, Caduet), pravastatin (Pravachol), or simvastatin (Zocor, Simcor, Vytorin);
- an antibiotic such as clarithromycin (Biaxin), rifabutin (Mycobutin), or rifampin (Rifater, Rifamate);
- antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or posaconazole (Noxafil);
- heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others;
- medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
- seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), phenobarbital (Solfoton); or
- certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), or ritonavir (Norvir, Kaletra).
|This list is not complete and there are many other drugs that can interact with efavirenz, emtricitabine, and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.|
Where can I get more information?
Your pharmacist can provide more information about efavirenz, emtricitabine, and tenofovir.
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.
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