Stavudine (By mouth)

Introduction

Stavudine (STAV-ue-deen)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Stavudine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s)

Zerit

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You should allow at least 12 hours between doses.
• You may take this medicine with or without food.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle of medicine well just before taking each dose.
• Stavudine is taken with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed at the correct time of day as part of your combination treatment.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the capsules at room temperature in a closed container, away from heat, moisture, and direct light. Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover capsules after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Store the oral liquid in the refrigerator. Do not freeze the liquid. Throw away any unused medicine after 30 days, but do not throw it in the trash. Flush it down the toilet or take it to a community take-back program when available.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using didanosine (Videx®, Videx EC®) or zidovudine or "AZT" (Combivir®, Retrovir®, Trizivir®). Tell your doctor if you use doxorubicin (Adriamycin®, Doxil®, Rubex®), hydroxyurea (Droxia®, Hydrea®), interferon (Intron-A®, Roferon-A®), or ribavirin (Copegus®, Rebetol®, Rebetron®, Ribasphere®, Virazole®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, or pancreas problems. Tell your doctor if you have gallstones, diabetes, a history of nerve problems, or if you are receiving kidney dialysis. Make sure your doctor knows if you drink alcohol on a regular basis.
• Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Stop taking the medicine and call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Stop using this medicine and check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
• Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
• This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
• When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Extreme weakness, tiredness, or confusion.
• Fever or chills.
• Increased hunger or thirst.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Shortness of breath or trouble with breathing.
• Sudden and severe stomach pain, nausea, vomiting, or lightheadedness.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Headache, dizziness, depression, or trouble sleeping.
• Loss of appetite.
• Mild skin rash or itching.
• Muscle pain.
• Unusual dreams.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088