STAVUDINE - stavudine capsule 
Aurobindo Pharma Limited

----------

Medication Guide


Stavudine Capsules, USP

Read this Medication Guide before you start taking stavudine capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. You and your healthcare provider should talk about your treatment with stavudine capsules before you start taking them and at regular check-ups. You should stay under your healthcare provider’s care when taking stavudine capsules.

What is the most important information I should know about
stavudine capsules?

Stavudine capsules
can cause serious side effects, including: 

1.   Build up of acid in your blood (lactic acidosis). Lactic acidosis can cause death and must be treated in the hospital. The risk of lactic acidosis may be higher if you: 

It is important to call your healthcare provider right away if you: 


2.   Liver problems. Some people (including pregnant women) who have taken stavudine capsules have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and death due to liver problems. Your healthcare provider should check your liver function while you are taking stavudine capsules. You should be especially careful if you have a history of heavy alcohol use or liver problems. Use of stavudine capsules with VIDEX EC or VIDEX (didnosine) may increase your risk for liver damage.

It is important to call your healthcare provider right away if you have:
 


3.   Swelling of the pancreas (pancreatitis) that may cause death has occurred when stavudine capsules were used with VIDEX EC or VIDEX (didanosine). Pancreatitis can happen at any time during your treatment with stavudine capsules.

It is important to call your healthcare provider right away if you have:
 


What are stavudine capsules?

Stavudine capsules are a prescription medicine used with other HIV medicines to treat human immunodeficiency virus (HIV) infection in children and adults. Stavudine belongs to a class of drugs called nucleoside analogues.

Stavudine capsules will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking stavudine capsules, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your healthcare provider regularly and report any medical problems that occur.

Who should not take
stavudine capsules?

Do not take
stavudine capsules if you: 


What should I tell my healthcare provider before taking stavudine capsules?


Before you take stavudine capsules, tell your healthcare provider 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 healthcare provider about how you can take part in this registry. 


Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, or herbal supplements. Stavudine capsules may affect the way other medicines work, and other medicines may affect how stavudine capsules work. 

Especially tell your healthcare provider if you take: 
 


Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

How should I take
stavudine capsules? 

What should I avoid while taking stavudine capsules? 


What are the possible side effects of stavudine capsules? 

Stavudine capsules can cause serious side effects including:


It is important to call your healthcare provider right away if you have: 


These changes may include: 


         - trunk
         - upper back and neck (buffalo hump)
         - breast or chest 


         - legs
         - arms
         - face
Your healthcare provider will monitor you for changes in your body fat. It is important to tell your healthcare provider if you notice any of these changes. 


The most common side effects of stavudine capsules 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 stavudine capsules. 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
stavudine capsules? 

Store stavudine capsules in a tightly closed container at room temperature at 15° to 30°C (59° to 86°F).

Keep
stavudine capsules and all medicines out of the reach of children and pets.

General information about the safe and effective use of
stavudine capsules

Avoid doing things that can spread HIV-1 infection to others. 


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use stavudine capsules for a condition for which they were not prescribed. Do not give stavudine capsules to other people, even if they have the same symptoms as you have. They may harm them. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place stavudine capsules in an unrecognizable closed container in the household trash.

This Medication Guide summarizes the most important information about stavudine capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about stavudine capsules that is written for health professionals. For more information, call 1-866-850-2876.

What are the ingredients in
stavudine capsules?

Active Ingredient:
stavudine

Inactive Ingredients:
microcrystalline cellulose, sodium starch glycolate, anhydrous lactose, and magnesium stearate. The hard gelatin shell consists of gelatin, sodium lauryl sulfate, titanium dioxide, yellow iron oxide, and red iron oxide. The capsules are printed with black ink containing black iron oxide.

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

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

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

Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India

Revised: 10/2012

Revised: 08/2013
 
Aurobindo Pharma Limited