NEVIRAPINE - nevirapine suspension 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Nevirapine Oral Suspension, USP

(ne vir' a peen)


What is the most important information I should know about nevirapine oral suspension?

Nevirapine oral suspension can cause severe liver and skin problems that may lead to death. These problems can happen at any time during treatment, but your risk is higher during the first 18 weeks of treatment.

Nevirapine oral suspension can cause serious side effects, including:




People who have higher CD4+ cell counts when they begin nevirapine oral suspension have a higher risk of liver problems, especially:



Stop taking nevirapine oral suspension and call your doctor right away if you have any of the following symptoms of liver problems with or without a skin rash:




Stop taking nevirapine oral suspension and call your doctor right away if you get a rash with any of the following symptoms:




See “What are the possible side effects of nevirapine oral suspension?”  for more information about side effects.


What is nevirapine oral suspension?


Nevirapine oral suspension is prescription HIV-1 medicines used with other HIV-1 medicines to treat HIV-1 (Human Immunodeficiency Virus 1) in adults and in children 15 days of age and older. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).



Do not take nevirapine oral suspension:



Before taking nevirapine oral suspension, tell your doctor about all your or your child’s medical conditions, including if you or your child:


Pregnancy Registry: There is a pregnancy registry for women who take nevirapine oral suspension 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 about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take St. John’s wort.



How should I take nevirapine oral suspension? 



Your doctor should start you with 1 dose each day to lower your chance of getting a serious rash. It is important that you only take 1 dose of nevirapine oral suspension each day for the first 14 days.


Switching from nevirapine oral suspension to nevirapine extended-release tablets:




If you take nevirapine oral suspension:


What are the possible side effects of nevirapine oral suspension?


Nevirapine oral suspension may cause serious side effects, including:


See “What is the most important information I should know about nevirapine oral suspension?”


The most common side effect of nevirapine oral suspension is rash.


Nevirapine oral suspension may cause decreased fertility in females. Talk to your doctor if you have concerns about fertility.


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 the safe and effective use of 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. You can ask your pharmacist or doctor for information about nevirapine oral suspension that is written for health professionals.



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.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


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

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

Revised: 05/2017

Revised: 5/2017
Aurobindo Pharma Limited