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USP DI Vol. II - STAVUDINE (Systemic)

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) isused in the treatment of the infection caused by the human immunodeficiencyvirus (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 destructionof the immune system. This may help delay the development of problems usuallyrelated to AIDS or HIV disease. Stavudine will not keep you from spreadingHIV to other people. People who receive this medicine may continue to havethe 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, andpain in the hands or feet. Check with your doctor if anynew health problems or symptoms occur while you are taking stavudine.

Stavudine is available only with your doctor's prescription, in the followingdosage 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 willdo. This is a decision you and your doctor will make. For stavudine, the followingshould be considered:

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

Pregnancy?

Note:

The combination of stavudine and didanosine should be used with cautionduring pregnancy.

Stavudine has not been studied in pregnant women. However, studies in animalshave shown that stavudine causes birth defects when given in very high doses.Before taking this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant.

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

Children?This medicine has been tested in children from birththrough adolescence and, in effective doses, has not been shown to cause differentside effects or problems than it does in adults. Studies on theextended-release capsule form of this medicine have been done only in adultpatients, and there is not specific information comparing use of extended-releasestavudine capsules in children with use in other age groups.

Older adults?Stavudine has not been studied specifically in olderpeople. Therefore, it is not known whether it causes different side effectsor problems in the elderly than it does in younger adults. Elderly patientsshould be closely monitored for signs and symptoms of peripheral neuropathy.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingstavudine, it is especially important that your health care professional knowif 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 withstavudine 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 stavudinemay increase the chance of liver toxicity or pancreatitis
  • Zidovudine (e.g., Retrovir)?May prevent stavudine from workingeffectively; using stavudine and zidovudine at the same time is not recommended

Other medical problems?The presence of other medicalproblems may affect the use of stavudine. Make sure you tell your doctor ifyou 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?Stavudinemay make liver disease worse in patients with liver disease, active alcoholabuse, history of alcohol abuse, obesity and other HIV medicine use.
  • Kidney disease?Patients with kidney disease may have an increasedchance 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 takemore of it, do not take it more often, and do not take it for a longer timethan your doctor ordered. Also, do not stop taking this medicine without checkingwith 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 withyour 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 fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of stavudine. Your dose may be different if you have kidneydisease. 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?40milligrams (mg) every twelve hours.
      • Adults and teenagers weighing up to 60 kg (132 pounds)?30 mgevery twelve hours.
      • Children weighing 30 kg (66 pounds) or more?30 mg every twelvehours.
      • Infants and children at least 14 days old and weighing less than30 kg (66 pounds)?1 mg per kg (0.45 mg per pound) of body weight, everytwelve 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-releasecapsules):
    • For treatment of HIV infection:
      • Adults and teenagers weighing 60 kilograms (kg) (132 pounds) or more?100milligrams (mg) one time per day.
      • Adults and teenagers weighing up to 60 kg (132 pounds)?75 mgone 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 yourchild.
      • 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 openedand 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 assoon as possible. However, if it is almost time for your next dose, skip themissed 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 themedicine 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 causethe medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat 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 atregular visits.

Do not take any other medicines without checking withyour doctor first. To do so may increase the chance of side effectsfrom stavudine.

HIV may be acquired from or spread to other people through infected bodyfluids, including blood, vaginal fluid, or semen. If youare infected, it is best to avoid any sexual activity involving an exchangeof body fluids with other people. If you do have sex, always wear (or haveyour partner wear) a condom (?rubber?). Only use condomsmade of latex, and use them every time you have vaginal,anal, or oral sex. The use of a spermicide (such as nonoxynol-9) mayalso 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. Donot use oil-based jelly, cold cream, baby oil, or shortening as a lubricant?theseproducts can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry theirown condoms. Birth control pills and diaphragms will help protect againstpregnancy, but they will not prevent someone from giving or getting the AIDSvirus. 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 sharingeven 1 needle or syringe can spread the virus. If you have any questions aboutthis, 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 mayneed medical attention.

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

    More common

      Tingling, burning, numbness, or pain in the hands or feet

    Less common

      Cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; joint pain; muscle pain; ; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing

    Rare

      Nausea and vomiting; stomach pain (severe)

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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    More common

      Chills with fever; loss of appetite; weight loss

    Less common

      Diarrhea; difficulty in sleeping; headache; lack of strength or energy; stomach pain (mild)

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


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