ABACAVIR AND LAMIVUDINE - abacavir and lamivudine tablet, film coated
Aurobindo Pharma Limited
Abacavir and Lamivudine Tablets USP
(a bak' a vir and la miv' ue deen)
What is the most important information I should know about abacavir and lamivudine tablets?
Abacavir and lamivudine tablets can cause serious side effects, including:
If you get a symptom from 2 or more of the following groups while taking abacavir and lamivudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir and lamivudine tablets.
||Nausea, vomiting, diarrhea, abdominal (stomach area) pain
||Generally ill feeling, extreme tiredness, or achiness
||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 and lamivudine tablets because of an allergic reaction, never take abacavir and lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ, TRIZIVIR, or ZIAGEN) again.
If your healthcare provider tells you that you can take abacavir and lamivudine tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one.
What are abacavir and lamivudine tablets?
Abacavir and lamivudine tablets are 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). Abacavir and lamivudine tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).
Abacavir and lamivudine tablets should not be used in children weighing less than 55 pounds (25 kg).
When used with other antiretroviral medicines to treat HIV-1 infection, abacavir and lamivudine tablets may help:
1. reduce the amount of HIV-1 in your blood. This is called “viral load”.
2. increase the number of CD4+ (T) cells in your blood, that help fight off other infections.
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 and lamivudine tablets do 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 and lamivudine tablets?
Do not take abacavir and lamivudine tablets if you:
What should I tell my healthcare provider before taking abacavir and lamivudine tablets?
Before you take abacavir and lamivudine tablets tell your healthcare provider if you:
Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
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 and lamivudine 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 and lamivudine 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 and lamivudine tablets with other medicines.
Tell your healthcare provider if you take:
How should I take abacavir and lamivudine tablets?
What are the possible side effects of abacavir and lamivudine 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 and lamivudine tablets 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 and lamivudine 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 and lamivudine tablets?
Keep abacavir and lamivudine tablets and all medicines out of the reach of children.
General information for safe and effective use of abacavir and lamivudine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir and lamivudine tablets for a condition for which it was not prescribed. Do not give abacavir and lamivudine tablets to other people, even if they have the same symptoms that you have. They 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 and lamivudine tablets that is written for health professionals.
For more information, call Aurobindo Pharma USA, Inc at 1-866-850-2876.
What are the ingredients in abacavir and lamivudine tablets?
Active ingredients: abacavir sulfate and lamivudine
Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Tablet film coating contains: Opadry Orange YS-1-13065-A that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
EPIVIR, TRIUMEQ, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies.
The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to the Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 038, India