Stiripentol
استیریپنتول
🧠 Nervous SystemAntiseizure
Market / country: 🇺🇸 USA
Diacomit (US)
🧮 Dose calculator
Dravet syndrome · Regimen source: FDA Diacomit · 2.2, Table 1
- • ≥1 y and ≥10 kg: may use 3 doses (16.67 mg/kg). Round to the nearest achievable dose (usually within 50–150 mg of 50 mg/kg/day). With a meal; do not open capsules. CBC before starting. FDA Diacomit · 2.2FDA Diacomit · 2.3FDA Diacomit · 2.1
Enter age and weight.
🛡️ Safety & information
Warnings
- • Somnolence; decreased appetite and weight; neutropenia and thrombocytopenia; phenylketonuria (powder); suicidal thoughts; withdraw gradually. FDA Diacomit · 5
Formulations
- 250 mg powder for oral suspension (packet) — sachet 🇺🇸 USA FDA Diacomit · 3
- 500 mg powder for oral suspension (packet) — sachet 🇺🇸 USA FDA Diacomit · 3
- 250 mg capsule — capsule 🇺🇸 USA FDA Diacomit · 3
- 500 mg capsule — capsule 🇺🇸 USA FDA Diacomit · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Diacomit · 8.1
“Risk Summary There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Diacomit · 8.2
“Risk Summary There are no data on the presence of stiripentol in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Diacomit · 8.4
“The safety and effectiveness of DIACOMIT have been established for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months and older and weighing 7 kg or more.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Diacomit · 8.5
“Clinical studies of DIACOMIT in Dravet syndrome did not include patients ≥65 years of age to determine whether they respond differently from younger patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA206709
- DailyMed (FDA label)FDA Diacomit
- MedlinePlus (NIH)Stiripentol
- WHO ATC/DDDN03AX17
- Darooyab (Iran)Stiripentol
🇮🇷 Registered in Iran Darooyab · G-685/Stiripentol
Dosage forms with Iranian generic codes, per Darooyab.
- 14155 · STRIPENTOL 250MG CAP · کپسول ستریپنتول ۲۵۰ میلیگرم
- 14157 · STRIPENTOL 500MG CAP · کپسول ستریپنتول ۵۰۰ میلیگرم
- 53029 · STIRIPENTOL POWDER, FOR SUSPENSION ORAL 250 mg · سوسپانسیون خوراکی ستیریپنتول ۲۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Diacomit · 3FDA Diacomit · 2.2, Table 1FDA Diacomit · 2.2FDA Diacomit · 2.3FDA Diacomit · 2.1FDA Diacomit · 5FDA Diacomit · SPL approval / marketing categoryFDA Diacomit · 8.1FDA Diacomit · 8.2FDA Diacomit · 8.4FDA Diacomit · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-685/Stiripentol
- Clinical review⚠ Unverified