ABACAVIR- abacavir tablet, film coated 
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MEDICATION GUIDE

Abacavir (a-BAK-a-vir) Tablets USP 300 mg

What is the most important information I should know about abacavir tablets?

Abacavir tablets can cause serious side effects, including:

Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir tablet and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.

If you get a symptom from 2 or more of the following groups while taking abacavir  tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets.


Symptom(s)
Group 1
Fever
Group 2
Rash
Group 3
Nausea, vomiting, diarrhea, abdominal (stomach area) pain
Group 4
Generally ill feeling, extreme tiredness, or achiness
Group 5
Shortness of breath, cough, sore throat

A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.

If you stop abacavir tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.

If your healthcare provider tells you that you can take abacavir tablets again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

What is abacavir tablets?

Abacavir tablet is a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

The safety and effectiveness of abacavir sulfate has not been established in children under 3 months of age.

When used with other antiretroviral medicines to treat HIV-1 infection, abacavir tablets may help:

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Abacavir tablets does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Who should not take abacavir tablets?

Do not take abacavir tablets if you:

What should I tell my healthcare provider before taking abacavir tablets?

Before you take abacavir tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with abacavir tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take abacavir tablets with other medicines.

Tell your healthcare provider if you take:

How should I take abacavir tablets?

What are the possible side effects of abacavir tablets?

You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

The most common side effects of abacavir sulfate in adults include:

The most common side effects of abacavir sulfate in children include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of abacavir tablets. For more information, ask your healthcare provider 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 abacavir tablets?

Keep abacavir tablets and all medicines out of the reach of children.

General information for safe and effective use of abacavir tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets for a condition for which it was not prescribed. Do not give abacavir tablets to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir tablets that is written for health professionals.

For more information go to www.ciplausa.com or call Cipla at 1-866-604-3268.

What are the ingredients in abacavir tablets?

Active ingredient: abacavir

Inactive ingredients:

Tablets:

microcrystalline cellulose, sodium starch glycolate, corn starch, hypromellose, magnesium stearate, colloidal silicon dioxide and opadry yellow 15C52843 (consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80).

Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

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

Revised: May 2018

Manufactured by

Cipla Limited

MIDC, Patalganga

M.S. 410220, INDIA

Manufactured for: Cipla USA, Inc.

1560 Sawgrass Corporate Parkway,

Suite 130 Sunrise, FL 33323

Revised: 8/2019
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