Pronunciation:

STAV-yoo-deen

Brand Names:

• Zerit
• Zerit Pediatrics

Dosage Forms:

• Capsule
• Powder for Suspension

Warnings:

Lactic acidosis and severe hepatomegaly with steatosis including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine, with or without hydroxyurea, in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression .

Lactic acidosis and severe hepatomegaly with steatosis including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Stavudine (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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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 no 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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Didanosine
• Doxorubicin Hydrochloride
• Hydroxyurea
• Ribavirin
• Zidovudine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the oral solution form in the refrigerator.

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:

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)

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.