VIRAMUNE - nevirapine tablet
State of Florida DOH Central Pharmacy
Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about VIRAMUNE?
VIRAMUNE can cause serious side effects. These include severe liver and skin problems which can cause death. The risk of these problems is greatest during the first 18 weeks of treatment, but these problems can also happen at any time during treatment.
Severe liver problems: Anyone who takes VIRAMUNE may get severe liver problems. In some cases, these liver problems can lead to liver failure and the need for a liver transplant, or death. You may get a rash if you have liver problems. People with higher risk of these problems include women or anyone with higher CD4+ cell counts when they begin VIRAMUNE treatment. Women with CD4+ cell counts higher than 250 cells/mm3 at the start of treatment have the greatest risk for liver damage.
If you are a woman with CD4+ cell >250 cells/mm3 or a man with CD4+ cell >400 cells/mm3, you and your doctor will decide if VIRAMUNE is right for you.
People who have abnormal liver test results and people with hepatitis B or C have a greater chance of getting liver problems and further increases in liver test results during treatment.
If you get any of the following symptoms of liver problems, stop taking VIRAMUNE and call your doctor right away:
Your doctor should see you and do blood tests often to check your liver function during the first 18 weeks of treatment with VIRAMUNE. You should continue to have your liver checked regularly during your treatment with VIRAMUNE. It is important for you to keep all of your doctor appointments.
Severe rash and skin reactions: Skin rash is the most common side effect of VIRAMUNE. Most rashes happen in the first 6 weeks of taking VIRAMUNE. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. If you get a rash with any of the following symptoms, stop using VIRAMUNE and call your doctor right away:
If your doctor tells you to stop treatment with VIRAMUNE because you have had the serious liver or skin problems described above, you should never take VIRAMUNE again.
These are not all the side effects of VIRAMUNE. See the section "What are the possible side effects of VIRAMUNE?" for more information.
What is VIRAMUNE?
VIRAMUNE is a medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
VIRAMUNE is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). VIRAMUNE works by lowering the amount of HIV in your blood ("viral load"). You must take VIRAMUNE with other anti-HIV medicines. When you take VIRAMUNE with other anti-HIV medicines, VIRAMUNE can lower your viral load and increase the number of CD4+ cells ("T cells"). CD4+ cells are a type of immune helper cell in the blood. VIRAMUNE may not have these effects in every person.
VIRAMUNE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking VIRAMUNE may still get infections common in people with HIV (opportunistic infections). It is very important that you stay under the care of your doctor.
Who should not take VIRAMUNE?
Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take VIRAMUNE if you have certain liver problems.
What should I tell my doctor before taking VIRAMUNE?
Before you take VIRAMUNE, tell your doctor if you:
Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. VIRAMUNE may affect the way other medicines work, and other medicines may affect how VIRAMUNE works. Especially tell your doctor if you take:
Also tell your doctor if you are taking the following drugs:
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take VIRAMUNE?
What are the possible side effects of VIRAMUNE?
VIRAMUNE may cause serious side effects.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of VIRAMUNE. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VIRAMUNE?
Keep VIRAMUNE and all medicines out of the reach of children.
General information about VIRAMUNE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIRAMUNE for a condition for which it was not prescribed. Do not give VIRAMUNE to other people, even if they have the same condition you have. It may harm them.
This Medication Guide summarizes the most important information about VIRAMUNE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about VIRAMUNE that is written for health professionals.
For more information, call Boehringer Ingelheim Pharmaceuticals, Inc., at 1-800-542-6257, or (TTY) 1-800-459-9906.
What are the ingredients in VIRAMUNE?
Active Ingredient: nevirapine
Viramune Tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate
Viramune Oral Suspension: carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate 80, sodium hydroxide, and purified water
This Medication Guide has been approved by the US Food and Drug Administration
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