Commonly Used Brand Name(s)Zerit, Zerit Pediatrics
Therapeutic ClassificationsAntiretroviral Agent
Pharmacologic ClassificationsNucleoside Reverse Transcriptase Inhibitor
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. Coadministration of stavudine and didanosine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine .
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Stavudine is used in combination with other antivirus medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Stavudine will not cure or prevent HIV infection or AIDS. It helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
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 first with your doctor.
Keep taking stavudine for the full time of treatment , even if you begin to feel better. Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.
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 doctor.
The capsule should be swallowed whole. Do not chew, crush or dissolve.
You may take this medicine with or without food.
Shake the oral liquid before use. Use a specially marked measuring cup or other device to measure each dose accurately.
This medicine comes with a Medication Guide and patient information leaflet. Read and follow the instructions in the guide or leaflet carefully. Talk to your doctor if you have any questions.
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 oral dosage forms (capsules or oral solution):
- For treatment of HIV infection:
- Adults and teenagers weighing 60 kilograms (kg) or more—40 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
- Adults and teenagers weighing up to 60 kg—30 mg every 12 hours. Your doctor may adjust your dose if needed.
- Children weighing 30 kg or more—30 mg every 12 hours. Your doctor may adjust your dose if needed.
- Infants and children at least 14 days old and weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 mg per kg of body weight every 12 hours. Your doctor may adjust your dose if needed.
- Infants from birth to 13 days old—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 mg per kg of body weight every 12 hours. Your doctor may adjust your dose if needed.
- For treatment of HIV infection:
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.
Use & StorageTOP
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 liquid in the refrigerator and get rid of any unused medicine after 30 days. Take any unused medicine to a community take-back program when available. If a program is not available in your area, ask your pharmacist about the best way to dispose of medicine you do not use. Do not throw it in the trash.
Ask your pharmacist how to dispose of any capsules you do not use.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of stavudine in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of stavudine in the elderly. However, elderly patients are more likely to have age-related kidney problems which may require an adjustment in the dose for patients receiving stavudine.
|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.|
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.
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 ProblemsTOP
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 history of, or
- Gallstones, active or history of, or
- Liver disease (includes hepatitis) or
- Obesity (being overweight) or
- Pancreatitis (inflammation of the pancreas), history of or
- Peripheral neuropathy (nerve disorder), history of or
- Use of other HIV medicines for a long period of time—Use with caution. May cause side effects to become worse.
- Diabetes—The oral liquid contains sucrose (sugar), which can make this condition worse.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
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 have 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.
Stop using this medicine and check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
This medicine may cause you to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.
When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (eg, pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.
Avoid drinking alcohol or alcoholic beverages while taking this medicine.
Do not take any other medicines without checking first with your doctor. To do so may increase the chance for side effects from stavudine.