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|Zerit XR

STAVUDINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Zerit
• Zerit XR

In Canada—

• Zerit

Another commonly used name is d4T .

Category

• Antiviral, systemic

Description

Stavudine (STAV-yoo-deen) (also known as d4T) is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS).

Stavudine (d4T) will not cure or prevent HIV infection or AIDS; however, it helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Stavudine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

Stavudine may cause some serious side effects, including peripheral neuropathy. Symptoms of peripheral neuropathy include tingling, burning, numbness, and pain in the hands or feet. Check with your doctor if any new health problems or symptoms occur while you are taking stavudine .

Stavudine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Capsules (U.S. and Canada)
• Extended-release capsules (U.S.)
• Oral solution (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For stavudine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to stavudine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—

Breast-feeding—It is not known whether stavudine passes into the breast milk. However, if your baby does not already have the AIDS virus, there is a chance that you could pass it to your baby by breast-feeding. Talk to your doctor first if you are thinking about breast-feeding your baby.

Children—This medicine has been tested in children from birth through adolescence and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. Studies on the extended-release capsule form of this medicine have been done only in adult patients, and there is not specific information comparing use of extended-release stavudine capsules in children with use in other age groups.

Older adults—Stavudine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults. Elderly patients should be closely monitored for signs and symptoms of peripheral neuropathy.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking stavudine, it is especially important that your health care professional know if you are taking any of the following:

• Chloramphenicol (e.g., Chloromycetin) or
• Cisplatin (e.g., Platinol) or
• Dapsone or
• Didanosine (e.g., ddI, Videx) or
• Ethambutol (e.g., Myambutol) or
• Ethionamide (e.g., Trecator-SC) or
• Hydralazine (e.g., Apresoline) or
• Isoniazid or
• Lithium (e.g., Eskalith, Lithobid) or
• Metronidazole (e.g., Flagyl) or
• Nitrofurantoin (e.g., Macrodantin) or
• Phenytoin (e.g., Dilantin) or
• Vincristine (e.g., Oncovin) or
• Zalcitabine (e.g., ddC, HIVID)—Use of these medicines with stavudine may increase the chance of peripheral neuropathy (tingling, burning, numbness, or pain in your hands or feet)

• Didanosine (e.g., ddI, Videx) or
• Hydroxyurea (e.g., Hydrea)—Use of these medicines with stavudine may increase the chance of liver toxicity or pancreatitis

• Zidovudine (e.g., Retrovir)—May prevent stavudine from working effectively; using stavudine and zidovudine at the same time is not recommended

Other medical problems—The presence of other medical problems may affect the use of stavudine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, active or a history of, or
• Liver disease or
• Obesity (being overweight) or
• Use of other HIV medicines over a long period of time—Stavudine may make liver disease worse in patients with liver disease, active alcohol abuse, history of alcohol abuse, obesity and other HIV medicine use.

• Kidney disease—Patients with kidney disease may have an increased chance of side effects

• Peripheral neuropathy—Stavudine may make this condition worse

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking stavudine for the full time of treatment , even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses . If you need help in planning the best times to take your medicine, check with your health care professional.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing—The dose of stavudine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of stavudine. Your dose may be different if you have kidney disease. If your dose is different, do not change it unless your doctor tells you to do so:

• For short-acting oral dosage forms (capsules, oral solution):
  • For treatment of HIV infection:
    • Adults and teenagers weighing 60 kilograms (kg) (132 pounds) or more—40 milligrams (mg) every twelve hours.
    • Adults and teenagers weighing up to 60 kg (132 pounds)—30 mg every twelve hours.
    • Children weighing 30 kg (66 pounds) or more—30 mg every twelve hours.
    • Infants and children at least 14 days old and weighing less than 30 kg (66 pounds)—1 mg per kg (0.45 mg per pound) of body weight, every twelve hours.
    • Infants from birth to 13 days old—0.5 mg per kg of body weight, every twelve hours
• For long-acting oral dosage form (extended-release capsules):
  • For treatment of HIV infection:
    • Adults and teenagers weighing 60 kilograms (kg) (132 pounds) or more—100 milligrams (mg) one time per day.
    • Adults and teenagers weighing up to 60 kg (132 pounds)—75 mg one time per day.
    • Children—Long-acting capsules have not been studied in children. Your doctor will determine which short-acting dosage form is right for your child.

    • Note:

      These capsules should be swallowed whole. Do not chew, crush or dissolve. If you have trouble swallowing a capsule whole, the capsule can be opened and all of the beads inside sprinkled over 2 tablespoons of yogurt or applesauce. You should not chew or crush the beads while swallowing.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store the oral solution form in the refrigerator. However, keep the medicine from freezing.
• Do not store the capsules or long-acting capsules in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits .

Do not take any other medicines without checking with your doctor first . To do so may increase the chance of side effects from stavudine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”) . Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex . The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly , are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs , get help to stop. Do not share needles or equipment with anyone . In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 11/28/1994
Revised: 05/04/2005

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