Description
Stavudine is used in combination with other medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.
Stavudine will not cure or prevent HIV infection or AIDS. It helps 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 other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of stavudine in children.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Didanosine
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.
- Atidarsagene Autotemcel
- Cabotegravir
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Hydroxyurea
- Orlistat
- Pexidartinib
- Ribavirin
- Tacrolimus
- Zidovudine
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.
- Methadone
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 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.
Proper Use
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. Read and follow the instructions carefully. Talk to your doctor if you have any questions.
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 oral dosage forms (capsules or oral solution):
- For treatment of HIV infection:
- Adults and children weighing 60 kilograms (kg) or more—40 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
- Adults and children weighing less than 60 kg—30 mg every 12 hours. Your doctor may adjust your dose as needed.
- Children weighing 30 kg or more—30 mg every 12 hours. Your doctor may adjust your dose as needed.
- 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 as 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 as needed.
- For treatment of HIV infection:
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 liquid in the refrigerator and throw away 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.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also using didanosine (Videx®).
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. 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.
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.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may cause you to lose fat from your legs, arms, or face. Talk to your doctor if you have any concerns.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves disease, polymyositis, or Guillain-Barré syndrome.
Avoid drinking alcohol or alcoholic beverages while taking this medicine.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.
Side Effects
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
- Burning, numbness, tingling, or painful sensations
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Incidence not known
- Black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- blurred vision
- chest pain
- chills
- constipation
- cough
- darkened urine
- decreased appetite
- depression or indentation of the skin
- diarrhea
- difficulty in moving
- difficulty swallowing
- fast heartbeat
- fast, shallow breathing
- fever
- general feeling of discomfort
- general tiredness and weakness
- hives, itching, skin rash
- indigestion
- joint pain or swelling
- light-colored stools
- loss of appetite
- muscle cramping, pains, or stiffness
- nausea
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination (severe)
- sleepiness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain or discomfort
- swollen glands
- tightness in the chest
- trembling or other problems with muscle control or coordination
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal pain
- vomiting
- yellow eyes or skin
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
- Headache
Incidence not known
- Trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
