Nevirapine is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Nevirapine is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Nevirapine is not a cure for HIV or AIDS, and should not be used to prevent HIV.

Nevirapine oral solution (liquid) is for use in adults and children as young as 15 days old. Nevirapine extended-release tablets are for use in adults and children who are at least 6 years old.

Nevirapine may also be used for purposes not listed in this medication guide.

Your blood will need to be tested often during the first few months you are taking nevirapine.

Nevirapine can cause severe or fatal liver problems. Stop taking this medicine and call your doctor at once if you have: nausea, loss of appetite, upper stomach pain, tiredness, fever, unexplained muscle pain or weakness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Stop taking nevirapine and get emergency medical help if you have: a fever, swelling in your face or tongue, skin pain, or a rash that spreads and causes blistering and peeling.

Nevirapine comes as a tablet, an extended-release tablet, and a suspension (liquid) to take by mouth with or without food. The tablet and suspension are usually taken once a day for 2 weeks and then twice a day after the first 2 weeks. The extended-release tablet is usually taken once a day, following at least two weeks of treatment with regular nevirapine tablets or suspension. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nevirapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow nevirapine with liquids such as water, milk, or soda.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Shake the liquid gently before each use to mix the medication evenly. Use an oral dosing cup or dosing syringe to measure your dose. It is best to use a syringe, especially if your dose is less than 5 mL (1 teaspoon). If you use a dosing cup, first drink all of the medication that you measured in the dosing cup. Then fill the dosing cup with water and drink the water to be sure that you get your full dose.

Nevirapine may control HIV but will not cure it. Continue to take nevirapine even if you feel well. Do not stop taking nevirapine or any of the other medications that you are taking to treat HIV or AIDS without talking to your doctor. Your doctor will probably tell you to stop taking your medications in a certain order. If you miss doses or stop taking nevirapine, your condition may become more difficult to treat.

If you do not take nevirapine for 7 days or longer, do not start taking it again without talking to your doctor. Your doctor will start you on a low dose of nevirapine, and increase your dose after 2 weeks.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended. Starting with a low dose can reduce your risk of skin reactions.

Carefully follow your doctor's instructions about how often to take this medicine.

Nevirapine must be given in combination with other antiviral medications and it should not be used alone.

Nevirapine can be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

While using nevirapine, you will need frequent blood tests (especially during the first 18 weeks of treatment).

Use nevirapine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor at once at the first sign of any skin rash, no matter how mild.

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 at room temperature away from moisture and heat.

You should not use nevirapine if you are allergic to nevirapine, or if you have moderate to severe liver disease.

Some medicines can interact with nevirapine and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• atazanavir;

• delavirdine;

• etravirine;

• itraconazole;

• ketoconazole;

• rifampin;

• rilpivirine;

• St. John's wort; or

• telaprevir.

To make sure nevirapine is safe for you, tell your doctor if you have:

• skin problems;

• liver disease (or a history of hepatitis or cirrhosis);

• kidney disease (or if you are on dialysis); or

• if you have ever taken delavirdine or efavirenz and they were not effective in treating your condition.

It is not known whether this medicine will harm an unborn baby. However, nevirapine may be more likely to cause liver damage in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant. 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.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of nevirapine on the baby.

Nevirapine can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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.

Do not give this medicine to a child without medical advice.

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.

If you have not taken nevirapine for 7 days in a row, call your doctor before you start taking the medicine again. You may need to start with a lower dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of liver damage.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share 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.

Get emergency medical help if you have signs of an allergic reaction: joint or muscle pain, fever, mouth sores, facial swelling, blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, pain or burning when you urinate, swelling in your legs or feet, cough, chest pain, trouble breathing, or swelling in your lips, tongue, or throat.

Nevirapine can cause life-threatening effects on the liver, especially in women. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: nausea, loss of appetite, upper stomach pain, tiredness, fever, unexplained muscle pain or weakness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Stop taking nevirapine and get emergency medical help if you have: a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, and a red or purple skin rash that spreads and causes blistering and peeling. This type of reaction is a medical emergency.

Nevirapine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with nevirapine. Tell 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;

• cold sores, sores on your genital or anal area;

• rapid heart rate, 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.

Common side effects of nevirapine may include:

• skin rash; 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.

Many drugs can interact with nevirapine, or make it less effective. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• antiviral medication to treat hepatitis C;

• an antibiotic or antifungal medicine;

• birth control pills or hormone replacement therapy;

• a blood thinner (warfarin and others);

• ergot medicine (dihydroergotamine, ergonovine, and others);

• heart or blood pressure medication;

• medicine to prevent organ transplant rejection; or

• seizure medication.

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.