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Stiripentol Dosage

Medically reviewed by Drugs.com. Last updated on Aug 7, 2019.

Applies to the following strengths: 250 mg; 500 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Dravet Syndrome

50 mg/kg/day orally in 2 or 3 divided doses
-If exact dose is not achievable with available dose strengths, round to nearest possible dose
Maximum dose: 3000 mg/day

Comments:
-There is no clinical data supporting the use of the drug as monotherapy in patients with Dravet syndrome.

Use: For the treatment of seizures associated with Dravet syndrome in patients 2 years or older taking clobazam.

Usual Pediatric Dose for Dravet Syndrome

2 years or older:
50 mg/kg/day orally in 2 or 3 divided doses
-If exact dose is not achievable with available dose strengths, round to nearest possible dose
Maximum dose: 3000 mg/day

Comments:
-There is no clinical data supporting the use of the drug as monotherapy in patients with Dravet syndrome.

Use: For the treatment of seizures associated with Dravet syndrome in patients 2 years or older taking clobazam.

Renal Dose Adjustments

Mild renal impairment: No adjustment recommended
Moderate to severe renal impairment: Not recommended

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended
Moderate to severe hepatic impairment: Not recommended

Dose Adjustments

Elderly: Has not been studied to determine whether they may respond differently; consider the possibility of age-related changes in renal and/or hepatic function.

For patients experiencing somnolence:
-Consider reducing dose of clobazam by 25%; if somnolence persists, a further reduction of 25% may be needed as well as dose adjustments of other drugs with sedating properties.

For patients experiencing gastrointestinal events, decreased appetite and weight loss:
-Consider reducing valproate by 30% per week.

Treatment Discontinuation:
-Gradual withdrawal is advisable whenever possible.
-If rapid withdrawal is medically necessary, appropriate monitoring is recommended.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Take orally with meals (dose should be divided and given 2 to 3 times a day)

Capsules: Swallow whole with a glass of water; capsules should not be opened or broken

Powder for Oral Suspension: Mix powder in a glass of water (100 mL); take immediately after mixing
-To ensure all medicine is taken, add a small amount of water (25 L) to glass and drink

Missed dose: If a dose is missed it should be taken as soon as possible
-If it is almost time for the next dose, the missed dose should not be taken, instead take scheduled dose
-Doses should not be doubled

Storage requirements:
-Store in a dry place; protect from light

General:
-Two clinical studies were performed in patients 3 to 18 years old with Dravet syndrome inadequately controlled on clobazam and valproate despite optimized therapy; the safety and efficacy for patients 2 years to less than 3 years was extrapolated from these studies.
-In these studies, the addition of stiripentol resulted in a significantly greater responder rate (defined as greater than 50% decrease in the frequency of generalized clonic or tonic-clonic seizures) compared to placebo; 43% and 25% of patients reported no generalized clonic or tonic-clonic seizures in study 1 and study 2, respectively, for the duration of the study.

Monitoring:
-Hematologic testing should be performed prior to initiation and repeated every 6 months
-Monitor growth of pediatric patients
-Monitor for somnolence
-Monitor for emergence of worsening depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-Patients/caregivers should be instructed to report any unusual change in mood or behavior, worsening of depression, or suicidal thoughts or behaviors to their healthcare provider immediately.
-Patients should be instructed not to stop therapy without speaking with their healthcare provider; additionally, they should not start or stop any other medications without consulting with their healthcare provider due to the high risk of drug interactions.
-Patients/caregivers should be instructed to report excessive sleepiness, especially if it effects eating and leads to weight loss.
-Patients should be instructed avoid performing hazardous tasks until they gain sufficient experience with this drug to understand how it affects their mental and/or motor performance.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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