Description
Stiripentol is used with clobazam to treat seizures in patients with Dravet syndrome.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Powder for Suspension
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 stiripentol in children 6 months of age and older and weighing 7 kilograms (kg) or more. Safety and efficacy have not been established in children younger than 6 months of age or weighing less than 7 kg.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of stiripentol in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution for patients receiving this medicine.
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.
- Mavacamten
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.
- Calcifediol
- Carbamazepine
- Citalopram
- Enzalutamide
- Fenfluramine
- Fosphenytoin
- Lumacaftor
- Methadone
- Mitotane
- Orlistat
- Phenytoin
- Rifampin
- St John's Wort
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.
- Cannabidiol
- Ginkgo
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- 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:
- Kidney disease, moderate to severe or
- Liver disease, moderate to severe—Use is not recommended.
- Phenylketonuria (PKU)—The oral liquid contains phenylalanine, which can make this condition worse.
Proper Use
Take this medicine only 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.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Swallow the capsule whole with a glass of water during a meal. Do not break or open it.
Mix the powder for suspension with a glass of water (100 mL) and drink it right away during a meal. Add a small amount of water (25 mL) to the drinking glass and drink all of the mixture to make sure there is no medicine left in the glass.
Stiripentol is used together with another seizure medicine (clobazam). Keep using all of your medicines unless your doctor tells you to stop.
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 powder for suspension):
- For seizures:
- Adults—Dose is based on body weight and must be determined by your doctor. The dose is 50 milligrams (mg) per kilogram (kg) of body weight per day given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
- Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 10 kilograms (kg) or more—50 milligrams (mg) per kilogram (kg) of body weight per day given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
- Weighing 7 kg to less than 10 kg—50 mg per kg of body weight per day given in 2 divided doses.
- Children 6 months to less than 1 year of age weighing 7 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is 50 mg per kg of body weight per day given in 2 divided doses.
- Children younger than 6 months of age or weighing less than 7 kg—Use and dose must be determined by your doctor.
- For seizures:
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
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the medicine in its original container. Do not store the mixed oral liquid. Take it right away after mixing.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may make you or your child drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with stiripentol may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Stiripentol may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.
Stiripentol may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or 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
- Aggression
- anxiety
- chest tightness
- cough producing mucus
- dry mouth
- fever
- headache
- irregular heartbeat
- irritability
- loss of strength or energy
- muscle pain or weakness
- nervousness
- restlessness
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- slurred speech
- sore throat
- stuffy or runny nose
- trouble breathing
- trouble sleeping
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
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
- Decreased appetite
- increased watering of the mouth
- nausea
- vomiting
- weight changes
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.
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