STAVUDINE- stavudine for solution 
Cipla Ltd.

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Medication Guide

Stavudine (stav' ue deen)

for Oral Solution USP 1mg/mL

What is the most important information I should know about Stavudine oral solution?

Stavudine can cause serious side effects, including:

            Build up of acid in your blood (lactic acidosis). Lactic acidosis can  happen in some people who take Stavudine oral solution or similar medicines (nucleoside analogues). Lactic acidosis is a serious medical emergency that can lead to death.

Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:

       Severe liver problems. Severe liver problems, including liver failure can happen in people who take stavudine. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Taking Stavudine oral solution with medicines that contain didanosine or hydroxyurea may increase your risk for liver problems.

Call your healthcare provider right away if you have any of the following symptoms of liver problems:

You may be more likely to get lactic acidosis or severe liver problems if you are female, are very overweight (obese), or have been taking nucleoside analogue medicines for a long time.

       Neurologic problems including weakness of your legs, feet, arms, or hands (motor weakness) and numbness, tingling or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy can be common and severe, and happens more often in people who have advanced HIV-1 disease, have a history of peripheral neuropathy, or in people who take other medicines that can cause peripheral neuropathy. In some cases, symptoms of neurologic problems may continue, worsen or temporarily worsen after you stop treatment with Stavudine oral solution.

Neurologic problems can be difficult to notice in children who take Stavudine oral solution. Ask your child's healthcare provider for the signs and symptoms of neurologic problems in children.

            Inflammation of your pancreas (pancreatitis) can happen in people who take Stavudine oral solution in combination with didanosine and can lead to death.

Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:

For more information about side effects, see "What are the possible side effects of Stavudine oral solution?"

What is Stavudine oral solution?

Stavudine is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV)-1 infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Do not take Stavudine oral solution if you:

Before taking Stavudine oral solution, tell your healthcare provider about all of your medical conditions, including if you:

Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a medicine called hydroxyurea.

Some medicines interact with stavudine. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Stavudine oral solution?

What should I avoid while taking Stavudine oral solution?

What are the possible side effects of Stavudine?

Stavudine can cause serious side effects including:

Your healthcare provider will monitor you for changes in your body fat. It is important to tell your healthcare provider if you notice any changes.

The most common side effects of stavudine include:

These are not all the possible side effects of stavudine.

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 oral solution?

Oral solution:

Keep Stavudine oral solution and all medicines out of the reach of children.

General Information about the safe and effective use of Stavudine oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Stavudine oral solution for a condition for which it was not prescribed. Do not give Stavudine oral solution to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Stavudine oral solution that is written for health professionals.

What are the ingredients in Stavudine oral solution?

Active Ingredient: stavudine

Inactive Ingredients:

Stavudine for Oral Solution: methyparaben, propylparaben, mannitol, carboxymethyl cellulose sodium, sodium saccharin and strawberry cream flavour.

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

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

CIPLA LTD.

Verna, Goa 403 722

INDIA

Revised: January 2019

Revised: 1/2019
Cipla Ltd.