What is the most important information I should know about Viramune?

• Women and patients with higher CD4 counts are at increased risk of liver problems while taking Viramune. Women with CD4 counts higher than 250 cells/ mm3 are at the greatest risk of these events. If you are a woman with CD4>250 cells/ mm3 or a man with CD4>400 cells/ mm3 you should not begin taking Viramune unless you and your doctor have decided that the benefit of doing so outweighs the risk.
• In rare cases, Viramune has caused severe liver damage resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.
• Severe, life-threatening skin reactions have been associated with the use of Viramune. Call your doctor immediately if you develop a rash with or without a fever, blistering, sores or lesions in your mouth, irritated eyes, swelling, or muscle or joint aches.
• Viramune may decrease the effectiveness of birth control pills, which could result in pregnancy. Talk to your doctor about appropriate forms of birth control.

What is Viramune?

• Viramune is an antiviral medication. It is in a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors. Viramune inhibits the reproduction of HIV in the body.
• Viramune is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Viramune is not a cure for HIV or AIDS.
• Viramune may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Viramune?

• Before taking this medication, tell your doctor if you have kidney or liver disease. You may need a dosage adjustment or special monitoring during therapy with Viramune.
• Viramune is in the FDA pregnancy category C. This means that it is not known whether Viramune will be harmful to an unborn baby. It is very important to treat HIV/ AIDS during pregnancy to reduce the risk of infecting the baby. Talk to your doctor about treatment options. A barrier method of contraception (e.g., condoms) is recommended during treatment with non-nucleoside reverse transcriptase inhibitors for the prevention of pregnancy.
• It is not known whether Viramune passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

How should I take Viramune?

• Take Viramune exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Viramune can be taken with or without food.
• Shake the suspension well before measuring a dose. Use a dose-measuring cup or syringe to measure each dose. After taking the dose, add a small amount of water to the dose-measuring device and drink this mixture also.
• It is important to take Viramune regularly to get the most benefit.
• Treatment of HIV/ AIDS almost always requires the use of two or more drugs. If you need to stop taking one of the medicines you are taking for HIV, you should stop all of them until you can talk to your doctor.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Viramune to monitor progress and side effects.
• Store Viramune tablets and suspension at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Viramune overdose may include swelling, fever, rash, fatigue, headache, insomnia, nausea, vomiting, and lung problems.

What should I avoid while taking Viramune?

• Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. Viramune is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.

What are the possible side effects of Viramune?

• Women and patients with higher CD4 counts are at increased risk of liver problems while taking Viramune. Women with CD4 counts higher than 250 cells/ mm3 are at the greatest risk of these events. If you are a woman with CD4>250 cells/ mm3 or a man with CD4>400 cells/ mm3 you should not begin taking Viramune unless you and your doctor have decided that the benefit of doing so outweighs the risk.
• In rare cases, Viramune has caused severe liver damage resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.
• Severe, life-threatening skin reactions have been associated with the use of Viramune. Call your doctor immediately if you develop a rash with or without a fever, blistering, sores or lesions in your mouth, irritated eyes, swelling, or muscle or joint aches.
• Stop taking Viramune and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, tongue, or face).
• Other, less serious side effects may be more likely to occur. Continue to take Viramune and talk to your doctor if you experience
  • nausea, vomiting, diarrhea, or abdominal pain;
  • headache;
  • numbness, tingling, or muscle pain; or
  • changes in body fat (e.g., increased fat in the upper back, neck, breast, and trunk and loss of fat from the legs, arms, and face).
• 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.

What other drugs will affect Viramune?

• Before taking Viramune, tell your doctor if you are taking any of the following medicines:
  • rifampin (Rimactane, Rifadin) or rifabutin (Mycobutin);
  • ketoconazole (Nizoral) or itraconazole (Sporanox);
  • protease inhibitors such as saquinavir (Invirase), indinavir (Crixivan), nelfinavir (Viracept), or ritonavir (Norvir);
  • products containing the herb Hypericum perforatum or St. John's wort;
  • methadone (Dolophine); or
  • birth control pills.
• You may not be able to take Viramune, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Viramune. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.