NEVIRAPINE - nevirapine hemihydrate suspension 
Aurobindo Pharma Limited

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MEDICATION GUIDE


Nevirapine Oral Suspension, USP
 
Read this Medication Guide before you start taking nevirapine oral suspension 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 nevirapine oral suspension? 
 
Nevirapine oral suspension can cause serious side effects. These include severe liver and skin problems that can cause death. These problems can happen at any time during treatment, but your risk is highest during the first 18 weeks of treatment.
 
1.  Severe liver problems: Anyone who takes nevirapine oral suspension 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.
 
People who have a higher CD4+ cell count when they begin nevirapine oral suspension treatment have a higher risk of liver problems, especially:
 

If you are a woman with CD4+ counts higher than 250 cells/mm3 or a man with CD4+ counts higher than 400 cells/mm3, you and your doctor will decide whether starting nevirapine oral suspension is right for you. 
 
In general, women have a higher risk of liver problems compared to men. 
 
People who have abnormal liver test results before starting nevirapine oral suspension treatment and people with hepatitis B or C also have a greater chance of getting liver problems.  
 
You may get a rash if you have liver problems.
 
Stop taking nevirapine oral suspension and call your doctor right away if you have any of the following symptoms of liver problems: 
 
Your doctor should see you and do blood tests often to check your liver function during the first 18 weeks of treatment with nevirapine oral suspension. You should continue to have your liver checked regularly during your treatment with nevirapine oral suspension. It is important for you to keep all of your doctor appointments.
 
2.  Severe rash and skin reactions:Skin rash is the most common side effect of nevirapine oral suspension. Most rashes happen in the first 6 weeks of taking nevirapine oral suspension. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using nevirapine oral suspension and call your doctor right away if you get a rash with any of the following symptoms:
 
If your doctor tells you to stop treatment with nevirapine oral suspension because you have had any of the serious liver or skin problems described above, you should never take nevirapine oral suspension again. 
 
See the section “What are the possible side effects of nevirapine oral suspension?” for more information.
 
What is nevirapine oral suspension? 
 
Nevirapine oral suspension is a prescription medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
 
Nevirapine is a type of anti-HIV medicine called a “non-nucleoside reverse transcriptase inhibitor” (NNRTI). Nevirapine oral suspension works by lowering the amount of HIV in your blood (“viral load”). You must take nevirapine oral suspension with other anti-HIV medicines. When you take nevirapine oral suspension with other anti-HIV medicines, nevirapine oral suspension 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. Nevirapine oral suspension may not have these effects in every person. 
 
Nevirapine comes in different forms. This Medication Guide provides information about nevirapine oral suspension.
 
Nevirapine oral suspension does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking nevirapine oral suspension may still get infections common in people with HIV (opportunistic infections). It is very important that you stay under the care of your doctor.
 
It is not known if nevirapine oral suspension lowers the chance of passing HIV to other people. Effective treatment combined with safer sex practices, may reduce the chance of passing HIV to others through sexual contact. Always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles. Take your HIV medicines as prescribed.
 
Who should not take nevirapine oral suspension? 
 
Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take nevirapine oral suspension if you have certain liver problems. 
 
Nevirapine oral suspension is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take nevirapine oral suspension.
 
What should I tell my doctor before taking nevirapine oral suspension?
 
Before you take nevirapine oral suspension, 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. Nevirapine oral suspension may affect the way other medicines work, and other medicines may affect how nevirapine oral suspension works.
 
You should not take nevirapine oral suspension if you also take:
 
Also tell your doctor if you take:
 
If you are not sure if you take a medicine above, ask your doctor or pharmacist.
 
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 nevirapine oral suspension?
 
What are the possible side effects of nevirapine oral suspension?
 
Nevirapine oral suspension may cause serious side effects, including:
 
The most common side effect of nevirapine oral suspension is rash.
 
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 nevirapine oral suspension. 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 nevirapine oral suspension?
 
Keep nevirapine oral suspension and all medicines out of the reach of children.
 
General information about nevirapine oral suspension.
 
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine oral suspension for a condition for which it was not prescribed. Do not give nevirapine oral suspension 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 nevirapine oral suspension. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about nevirapine oral suspension that is written for health professionals.
 
For more information, call 1-866-850-2876.
 
What are the ingredients in nevirapine oral suspension? 
 
Active ingredient: nevirapine 
 
Inactive ingredients: carbopol 974PNF, methylparaben, propylparaben, non crystallizing sorbitol solution, sucrose, propylene glycol, polysorbate 80, sodium hydroxide, and purified water. 

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
 
Revised: 09/2012 

This Medication Guide has been approved by the U.S. Food and Drug Administration.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Revised: 02/2013
 
Aurobindo Pharma Limited