NEVIRAPINE - nevirapine tablet, extended release 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Nevirapine Extended-Release Tablets USP
(ne vir' a peen)

What is the most important information I should know about
nevirapine extended-release tablets?

Nevirapine extended-release tablets
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 extended-release tablets
can cause serious side effects, including:

People who have higher CD4+ cell counts when they begin nevirapine extended-release tablets have a higher risk of liver problems, especially:

Stop taking nevirapine extended-release tablets 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 extended-release tablets 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 extended-release tablets because you have had any of the severe liver or skin symptoms listed above, you should never take nevirapine extended-release tablets again.

See “What are the possible side effects of nevirapine extended-release tablets?” for more information about side effects.

What are nevirapine extended-release tablets?

Nevirapine extended-release tablets and nevirapine oral solution are 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 or older. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Nevirapine extended-release tablets are a prescription medicine used with other HIV-1 medicines to treat HIV-1 (Human Immunodeficiency Virus 1) in adults and in children 6 years of age to less than 18 years of age.

Do not take nevirapine extended-release tablets:

Before taking nevirapine extended-release tablets, 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 extended-release tablets 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 extended-release tablets?


Starting nevirapine extended-release tablets when this is the first time you are taking any form of nevirapine:


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


2. Day 15, take nevirapine extended-release tablets 1 time a day as prescribed by your doctor.

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



What are the possible side effects of nevirapine extended-release tablets?


Nevirapine extended-release tablets may cause serious side effects, including:


See “What is the most important information I should know about nevirapine extended-release tablets?”


The most common side effect of nevirapine extended-release tablets is rash.


Nevirapine extended-release tablets 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 extended-release tablets. 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 extended-release tablets?


Keep nevirapine extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of
nevirapine extended-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine extended-release tablets for a condition for which it was not prescribed. Do not give nevirapine extended-release tablets to other people, even if they have the same condition you have. They may harm them. You can ask your pharmacist or doctor for information about nevirapine extended-release tablets that is written for health professionals.

What are the ingredients in
nevirapine extended-release tablets?

Active ingredient: nevirapine

Inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, hypromellose, lactose monohydrate and sodium stearyl fumarate.

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


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 11/2018

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse Aurobindo Pharma Limited or its products.

Revised: 11/2018
Aurobindo Pharma Limited