Cenobamate
سنوبامات
🧠 Nervous SystemAntiepileptic
Market / country: 🇺🇸 USA
Xcopri (US)
🧮 Dose calculator
Epilepsy (complex partial / absence seizures) · Regimen source: FDA Xcopri · 2.2, Table 1FDA Xcopri · 2.3
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to cenobamate; familial short QT syndrome. FDA Xcopri · 4
Warnings
- • DRESS with rapid titration; QT shortening; suicidal ideation; somnolence. FDA Xcopri · 5
Formulations
- 12.5 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
- 25 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
- 50 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
- 100 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
- 150 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
- 200 mg tablet — tablet 🇺🇸 USA FDA Xcopri · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xcopri · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of XCOPRI in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xcopri · 8.2
“Risk Summary There are no data available on the presence of cenobamate in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Xcopri · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xcopri · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )] .”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Xcopri · 8.3
“Contraception Women of reproductive potential concomitantly using oral contraceptives should use additional or alternative non-hormonal birth control [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .”
🔗 Reference links
- FDA (approval record)NDA212839
- DailyMed (FDA label)FDA Xcopri
- MedlinePlus (NIH)Cenobamate
- WHO ATC/DDDN03AX25
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Xcopri · 3FDA Xcopri · 2.2, Table 1FDA Xcopri · 2.3FDA Xcopri · 4FDA Xcopri · 5FDA Xcopri · SPL approval / marketing categoryFDA Xcopri · 8.1FDA Xcopri · 8.2FDA Xcopri · 8.4FDA Xcopri · 8.5FDA Xcopri · 8.3
- 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 · search
- Clinical review⚠ Unverified