Stiripentol

Stiripentol (stir-ih-PEN-tol) is the generic name (non-brand name) of a seizure medicine with the brand name Diacomit® from Biocodex.  

Stiripentol is approved for use:

  • In the US, the FDA has approved stiripentol in combination with clobazam (Onfi) to treat seizures associated with Dravet syndrome in persons 2 years of age and older. In other countries, stiripentol is approved to be used in combination with both valproic acid and clobazam for seizures in Dravet syndrome.
Diacomit

Capsules:

250 mg

500 mg

Oral Powder for suspension (Sachets):

250 mg

500 mg

Used to treat

Dravet Syndrome

Forms

Capsules:

250 mg

500 mg

 

Oral Powder for suspension (Sachets): 

250 mg

500 mg

Dosing

Stiripentol is usually started at a dose of 5-10 mg/kg/day divided into 2 or 3 equal doses and gradually increased up to a maximum dose of 50 mg/kg/day (to a maximum 3000 mg/day) over 2-4 weeks. Older children and adults often require lower doses (20-30 mg/kg/d) as they may not tolerate doses as high as 50 mg/kg/day.

As stiripentol interacts with how the body breaks down clobazam and fenfluramine, doses of both of these medications often need to be reduced when stiripentol is added.

Follow your prescribing provider's instructions for how much to take and when to make changes.

How to take and store Stiripentol?

How to take:

Take stiripentol exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

Check the number and strength of the capsules or powder you get from the pharmacy. If your provider changes your dose, the strength of capsules or powder may be different.

Stiripentol is usually taken 2 or 3 times a day.

Stiripentol is best taken with food to reduce the chance of stomach upset. The capsules should be swallowed whole and should not be opened.

For the oral powder, follow the directions for mixing the powder with water. Always use an accurate measuring spoon or syringe to make sure the amount is correct. Do not use a regular teaspoon.

Take only the amount that your provider tells you to take. If you take an extra dose, call your provider for advice. If you take a larger number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room.

How to store:

Store at room temperature (below 86oF, 30oC).

Keep away from light and moisture.

Keep all medicines out of reach of children.

What if I forget?

Taking the right amount of seizure medicine on time every day is the most important way to control seizures. Try these steps to help you remember when to take stiripentol.

  • If you miss a dose, take it as soon as you remember it.
  • If it is almost time for the next dose, check with your health care provider for advice.
  • To avoid missed doses, use a pillbox or to set an alarm on your watch or on phone.
  • Use an online seizure diary or text message system like Texting 4 Control to send you reminders of when to take medicines.
  • Write down any missed doses in your seizure calendar. Share this with your health care provider at each visit.
How does Stiripentol affect the brain?

Brain cells normally talk to each other using electrical signals and chemicals. Seizures can happen when there is too much excitation of brain cells, or not enough inhibition. Stiripentol works by increasing inhibition. Stiripentol also affects how certain other medications are broken down, and can lead to increased levels of some medications, such as clobazam and fenfluramine.

How does the body digest Stiripentol?

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How well does the Stiripentol work?

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What are the most common side effects of Stiripentol?

Decreased appetite and weight loss

Feeling tired or sleepy

Low muscle tone, being off balance

In some cases the above side effects may be due to the levels of other co-medications (such as clobazam or valproic acid) getting too high, as stiripentol decreases the body’s ability to metabolize these other medications.

Stiripentol can also cause low white blood cell and platelet counts. It is recommended that a blood count be obtained before starting stiripentol and then periodically

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo. Such behavior is possible but rare with stiripentol.

What are the most serious side effects of Stiripentol?

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What else is Stiripentol used for?

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Who should not take Stiripentol?

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Can Stiripentol be taken with other medicines?

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What are the effects of Stiripentol on Children?

The effects of stiripentol in children are as described above.

If a woman takes Stiripentol during pregnancy will it hurt the baby?

Effect of seizure medicines during pregnancy: In the United States, the FDA assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Stiripentol is listed in Pregnancy Category C. This means that caution is advised, but the benefits of the medicine may outweigh the potential risks.

Stiripentol is typically used in Dravet syndrome – pregnancies in women with this syndrome are rare.

Talk to your health are providers if you are pregnant or plan to become pregnant.

The risk of birth defects is generally higher in children of women who:

Take more than one seizure medicine at the same time

Have a family history of birth defects

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) each day of the vitamin called folic acid (also called folate). This vitamin is thought to help prevent birth defects affecting the brain and spinal cord, called neural tube defects. The most common of these is known as spina bifida. 

Women at high risk of having a child with a birth defect (such as those with a birth defect in a previous pregnancy or taking certain seizure medicines) may be asked to take 4 mg (4000 mcg) daily before and during pregnancy.

Talk to your health care provider about using folic acid and how much to take.

Start taking this vitamin before you become pregnant.

If you were taking stiripentol while pregnant, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 (www.aedpregnancyregistry.org).

Seizures during pregnancy: Some women may have more seizures during pregnancy, because of hormone changes and how seizure medicine is handled by your body.

Talk to your health care provider before pregnancy about seizures and if medicine changes may be needed.

Know when to check blood levels of medicine during and after pregnancy.

The dose of seizure medicine may need to be adjusted during and after pregnancy.

Breastfeeding: No information is available on stiripentol in a woman's breast milk.

Women who wish to breastfeed should talk to their doctor about the best medicine to use during pregnancy and when breastfeeding.

If you choose to breastfeed, have the baby followed closely by a health care professional. Check the baby for drowsiness and keep track of their weight gain and development, especially if you are taking more than one seizure medicine.

Talk to your health care team about any concerns that arise and the benefits and risks of breastfeeding.

Contraception: There are no known interactions of stiripentol with hormonal birth control.

What are the effects of Stiripentol on Seniors

There is no data on the use of stiripentol in seniors.

What are the dose ranges for Stiripentol?

The best amount of any seizure medicine is the amount that controls seizures without causing bothersome side effects. This depends on many factors, which are different for every individual.

Blood levels are not typically monitored for stiripentol.

Read the package insert of Stiripentol

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