Stavudine is an antiviral medicine that is used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). Stavudine is not a cure for HIV or AIDS.

Stavudine may also be used for purposes not listed in this medication guide.

Do not take this medicine with didanosine or zidovudine, or with any other medicine that contains stavudine.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Stavudine can also cause serious or life-threatening effects on your liver or pancreas. Call your doctor at once if you have: stomach pain or swelling, fever, nausea, vomiting, easy bruising or bleeding, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Stavudine comes as a capsule and as an oral solution (liquid) to take by mouth. It is usually taken twice a day (every 12 hours), with or without food and with plenty of water. To help you remember to take stavudine, take it at around the same times each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take stavudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are giving the oral solution to a child, shake the bottle well before each use to mix the medication evenly. Use the measuring cup provided to measure the child's dose.

Stavudine controls HIV infection but does not cure it. Continue to take stavudine even if you feel well. Do not stop taking stavudine without talking to your doctor. When your supply of stavudine starts to run low, get more from your doctor or pharmacist. If you miss doses or suddenly stop taking stavudine, your condition may become more difficult to treat.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times. You may take stavudine with or without food.

Shake the liquid medicine before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Stavudine doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store stavudine capsules at room temperature away from moisture and heat. Keep the bottle tightly closed.

Store stavudine liquid in the refrigerator, do not freeze. Throw away any unused liquid after 30 days.

You should not take stavudine if you are allergic to it. Do not take stavudine with didanosine or zidovudine, or with any other medicine that contains stavudine.

Stavudine can cause severe or life-threatening effects on your liver or pancreas. Tell your doctor if you have liver disease or a history of pancreatitis.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• liver disease, including hepatitis C;

• diabetes (stavudine liquid may contain sucrose);

• gallstones;

• numbness, tingling, or pain in your hands or feet;

• problems with your pancreas; or

• if you drink large amounts of alcohol.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules at room temperature and away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator and dispose of the unused portion after 30 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of pancreas or liver damage.

Using stavudine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Stavudine may cause serious side effects. Call your doctor at once if you have:

• numbness, tingling, or pain in your hands or feet;

• weakness in your legs, feet, arms, or hands;

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• pancreatitis--fever, severe pain in your upper stomach spreading to your back, nausea and vomiting.

Stavudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken stavudine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of stavudine may include:

• weakness, numbness, tingling, or burning pain in your hands or feet;

• nausea, vomiting, diarrhea;

• rash; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• hydroxyurea.

This list is not complete. Other drugs may affect stavudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of stavudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.