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Another NameDiacomit,司替戊醇,斯利潘托
IndicationsStiripentol is suitable for treating epileptic seizures associated with Dravet syndrome (DS).
Reg No.12 L 1053/23
Inspection NO.3178-23
The original pharmaceutical factory of Stiripentol is Biocodex, a French company. On August 20, 2018, the FDA (US Food and Drug Administration) approved the marketing of Stiripentol (trade name Diacomit).
Stiripentol is used to treat epileptic seizures in Dravet syndrome patients aged 2 years or older who are taking clobazam.
Stiripentol is a gamma aminobutyric acid (GABA) enhancer that can inhibit GABA metabolism and increase GABA concentration in the central nervous system, improving clinical symptoms in children with Dravet syndrome and reducing the frequency of seizures.
Stiripentol
Stiripentol is suitable for treating epileptic seizures associated with Dravet syndrome (DS).
There are no adequate data on the developmental risks associated with the use of Stiripentol in pregnant women. Administration of stiripentol to pregnant animals produced evidence of developmental toxicity, including increased incidences of fetal malformations, increased embryofetal and pup mortality, and decreased embryofetal and pup growth, at maternal doses lower than the recommended clinical dose.
There are no data on the presence of stiripentol in human milk, the effects on the breastfed infant, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Stiripentol and any potential adverse effects on the breastfed infant from Stiripentol or from the underlying maternal condition.
The safety and effectiveness of Stiripentol have been established for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months and older and weighing 7kg or more. Use of Stiripentol in this pediatric population is supported by 2 multicenter placebo-controlled, double-blind randomized studies in patients 3 to18 years of age with additional pharmacokinetic and safety data in patients 6 months to less than 3 years of age.
The safety and effectiveness of Stiripentol have not been established in pediatric patients below the age of 6 months or who weigh less than 7kg.
Clinical studies of Stiripentol in Dravet syndrome did not include patients ≥65 years of age to determine whether they respond differently from younger patients. The possibility of age-associated hepatic and renal function abnormalities should be considered when using Stiripentol in patients ≥65 years of age.
There is no formal study of the pharmacokinetics and metabolism of Stiripentol in patients with renal impairment. However, since Stiripentol metabolites are eliminated mainly through the kidney, administration to patients with moderate or severe renal impairment is not recommended.
There has been no formal study of the pharmacokinetics of Stiripentol in patients with liver impairment. However, since the drug is mainly metabolized by the liver, administration to patients with moderate or severe liver impairment is not recommended.
There are no data concerning overdose in humans. In mice treated with high doses of stiripentol (600 to 1800 mg/kg i.p.), decreased motor activity and decreased respiration were observed. Treatment of an overdose should be supportive (symptomatic measures in intensive care units).
Store in a dry place at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original package to protect from light.
The median time to stiripentol peak plasma concentration is 2 to 3 hours.
from FDA，2022.07
