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

Stavudine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, and feeling very weak or tired. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. 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). Before taking stavudine, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to stavudine in the past, such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

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.

What should I discuss with my healthcare provider before taking stavudine?

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.

Stavudine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, and feeling very weak or tired. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. 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. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. 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.