NEVIRAPINE- nevirapine tablet, coated
Carlsbad Technology, Inc.
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MEDICATION GUIDE
Nevirapine Tablets, USP
(ne vir' a peen)
Read this Medication Guide before you start taking nevirapine 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?
Nevirapine 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 higher during the first 18 weeks of treatment.
People who have a higher CD4+ cell count when they begin nevirapine 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 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 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 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. You should continue to have your liver checked regularly during your treatment with nevirapine. It is important for you to keep all of your doctor appointments.
If your doctor tells you to stop treatment with nevirapine because you have had any of the serious liver or skin problems described above, you should never take nevirapine again.
See the section “ What are the possible side effects of nevirapine?” for more information.
What is nevirapine?
When used with other HIV medicines, nevirapine may:
Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
Nevirapine does not cure HIV infection or AIDS.
Nevirapine does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Nevirapine.
Avoid doing things that can spread HIV-1 infection to others:
Ask your doctor if you have any questions on how to prevent passing HIV to other people.
Who should not take nevirapine?
Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take nevirapine if you have certain liver problems.
Nevirapine is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take nevirapine.
What should I tell my doctor before taking nevirapine?
Before you take nevirapine, tell your doctor if you:
Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
Tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Nevirapine may affect the way other medicines work, and other medicines may affect how nevirapine works.
You should not take nevirapine 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?
Starting nevirapine tablets:
Starting nevirapine extended-release tablets when this is the first time you are taking any form of nevirapine:
Switching from nevirapine tablets to nevirapine extended-release tablets: Take nevirapine extended-release tablet 1 time a day as prescribed by your doctor.
You may sometimes pass a soft mass in your stools (bowel movement) that looks like your nevirapine extended-release tablets. This will not affect the way your medicine works.
What are the possible side effects of nevirapine?
Nevirapine may cause serious side effects, including:
See “ What is the most important information I should know about nevirapine?”
The most common side effect of nevirapine 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. 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?
Keep nevirapine and all medicines out of the reach of children.
General information about nevirapine
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine for a condition for which it was not prescribed. Do not give nevirapine 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about nevirapine that is written for health professionals.
For more information, call Carlsbad Tech 1(855)397-9777
What are the ingredients in nevirapine? Active ingredient: nevirapine Inactive ingredients:
Nevirapine Tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, silicon dioxide and magnesium stearate.
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured by:
Distributed by:
ScieGen Pharmaceuticals, Inc. Carlsbad Tech
Hauppauge, NY 11788 USA 5928 Farnsworth Court
Carlsbad, CA 92008 USA
Rev. 10/15
The brands listed are trademarks of their respective owners and are not trademarks of ScieGen Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse ScieGen Pharmaceuticals, Inc., or its products.