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What is stavudine?

Stavudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Stavudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Stavudine is not a cure for HIV or AIDS.

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

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not use this medication if you are allergic to stavudine.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking stavudine, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease;
• diabetes; or
• a history of pancreatitis.

Some people have developed a life-threatening condition called lactic acidosis while taking stavudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Stavudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking stavudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Stavudine may also be more likely to cause lactic acidosis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using stavudine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether stavudine had any effect on the baby.

You should not breast-feed while you are using stavudine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

If you have diabetes, you should know that the liquid form of this medication contains 50 milligrams (mg) of sucrose (sugar) per milliliter (mL). This is equal to 250 milligrams of sugar per teaspoon (5 mL) of stavudine liquid.

Avoid drinking alcohol while taking stavudine. Alcohol may increase the risk of damage to the pancreas and/or liver.

Taking stavudine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include numbness, burning, pain, or tingly feeling, nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Stop using stavudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

• liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;
• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
• high blood sugar - increased thirst, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting; or
• any signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, or unusual weakness.

Less serious side effects may include:

• diarrhea;
• muscle pain;
• headache;
• mild skin rash; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking this medication, tell your doctor if you are using any of the following drugs:

• didanosine (Videx);
• doxorubicin (Adriamycin);
• hydroxyurea (Droxia, Hydrea);
• interferon-alfa (Roferon, Intron, Rebetron);
• ribavirin (Rebetol, Ribasphere, Copegus Virazole); or
• zidovudine (Retrovir).

This list is not complete and there may be other drugs that can interact with stavudine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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