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

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

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

Viramune XR 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 Viramune XR.

Viramune XR 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).

Viramune XR may also cause severe or life-threatening skin reactions. Stop taking this medicine 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.

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.

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

Viramune XR 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 Viramune XR, you will need frequent blood tests (especially during the first 18 weeks of treatment).

Use Viramune XR 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 Viramune XR if you are allergic to Viramune XR, or if you have moderate to severe liver disease.

Some medicines can interact with Viramune XR 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 Viramune XR 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, Viramune XR 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.

Viramune XR 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 Viramune XR 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.

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.

Viramune XR 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 this medicine: 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).

Viramune XR may also cause severe or life-threatening skin reactions. Stop taking Viramune XR 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.

Viramune XR 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 this medicine. 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 Viramune XR 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 Viramune XR, 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 Viramune XR. 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.