efavirenz

Efavirenz may cause serious psychiatric symptoms including severe depression, suicidal thoughts, aggression, extreme fear, or unusual behavior. Contact your doctor at once if you have any of these side effects.

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take efavirenz with astemizole (Hismanal), bepridil (Vascor), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), voriconazole (Vfend), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking efavirenz.

There are many other medicines that can interact with efavirenz, or make it less effective. 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.

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.

Taking efavirenz 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 is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Efavirenz is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Efavirenz is not a cure for HIV or AIDS.

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

Do not use this medication if you are allergic to efavirenz, or if you are using any of the following drugs:

• astemizole (Hismanal);
• bepridil (Vascor);
• cisapride (Propulsid);
• midazolam (Versed) or triazolam (Halcion);
• pimozide (Orap);
• voriconazole (Vfend); or
• ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

Using any of these medicines while you are taking efavirenz can cause serious medical problems or death.

Before taking efavirenz, tell your doctor if you are allergic to any drugs, or if you have

• liver disease (including hepatitis B or C);
• high cholesterol or triglycerides; or
• if you have ever taken delavirdine (Rescriptor) or nevirapine (Viramune) and they were not effective in treating your condition.

If you have any of these conditions, you may not be able to use efavirenz, 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 efavirenz without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking efavirenz.

HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using efavirenz. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether efavirenz had any effect on the baby.

You should not breast-feed while you are using efavirenz. 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.

Take efavirenz exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine with a full glass of water.

Efavirenz can be taken with or without food. Avoid taking with a high-fat meal, which can make it harder for your body to absorb the medication.

Efavirenz can cause side effects such as mood or behavior changes. These symptoms may improve the longer you take the medication. Taking efavirenz at bedtime may also lessen these effects. Contact your doctor if you have more serious symptoms such as severe depression or thoughts of hurting yourself.

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

Do not take efavirenz as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to efavirenz if you do not take it in combination with other HIV medicines your doctor has prescribed.

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. It is important that you not miss any scheduled visits to your doctor.

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.

Store efavirenz at room temperature away from moisture and heat.

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.

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an efavirenz overdose may include confusion, lack of balance or coordination, severe mood or behavior changes, or thoughts of suicide.

If you also take an antacid, take it at least 1 hour before or after taking efavirenz. Do not take antacids at the same time as taking efavirenz.

Efavirenz 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.

Avoid drinking alcohol. It can increase some of the side effects of efavirenz.

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

Taking efavirenz 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.

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.

Efavirenz may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, chills, body aches, flu symptoms; or
• any other signs of new infection.

Less serious side effects may be more likely to occur, such as:

• mild nausea, vomiting, or stomach pain;
• diarrhea or constipation;
• cough;
• blurred vision;
• headache, dizziness, tired feeling;
• trouble concentrating;
• muscle or joint pain;
• sleep problems (insomnia), unusual dreams; 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.

There are many other medicines that can interact with efavirenz, or make it less effective. Before taking efavirenz, tell your doctor if you are using any of the following drugs:

• sildenafil (Viagra);
• St. John's wort;
• a blood thinner such as warfarin (Coumadin);
• a cholesterol medication such as Lipitor or Zocor;
• an antibiotic such as clarithromycin (Biaxin), itraconazole (Sporanox), rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• heart or blood pressure medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan);
• other HIV medicines such as amprenavir (Agenerase), indinavir (Crixivan), lopinovir/ritonavir (Kaletra), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase); or
• seizure medications such as phenytoin (Dilantin) or carbamazepine (Tegretol).

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

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.

Your pharmacist has more information about efavirenz written for health professionals that you may read.

Efavirenz is available with a prescription under the brand name Sustiva. 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.

• Sustiva 50 mg-gold and white capsules
• Sustiva 100 mg-white capsules
• Sustiva 200 mg-gold capsules