Felbamate
فلبامات
🧠 Nervous SystemAntiseizure (dicarbamate)
Market / country: 🇺🇸 USA
Felbatol (US)
🧮 Dose calculator
Epilepsy (complex partial / absence seizures) · Regimen source: FDA Felbatol · Dosage and Administration
- • Or in 4 doses. Adjunct: reduce other AEDs by 20% (up to 33%); increase by 1200 mg/day weekly. Only when epilepsy is severe enough that aplastic anaemia risk is acceptable. FDA Felbatol · Dosage and AdministrationFDA Felbatol · Boxed Warning
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to felbamate or other carbamates; history of blood dyscrasia or hepatic dysfunction. FDA Felbatol · Contraindications
Warnings
- • Boxed warning: aplastic anaemia (>100-fold) and hepatic failure — only in very severe epilepsy, with haematology consultation and informed consent. FDA Felbatol · Boxed Warning
- • Suicidal thoughts and behaviour; do not stop abruptly (seizures, status epilepticus). FDA Felbatol · Warnings
Renal adjustment
- • eGFR < 60: Renal impairment: halve the starting and maintenance doses. FDA Felbatol · Dosage and Administration
Formulations
- 400 mg tablet (scored) — tablet 🇺🇸 USA FDA Felbatol · How Supplied
- 600 mg tablet (scored) — tablet 🇺🇸 USA FDA Felbatol · How Supplied
- 600 mg/5 mL oral suspension — suspension 🇺🇸 USA FDA Felbatol · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Felbatol · Pregnancy
“Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Felbatol · Nursing Mothers
“Felbamate has been detected in human milk.”
- 👶 ChildrenUse with caution
Label: established only for Lennox-Gastaut in children; not established in other children. FDA Felbatol · Pediatric Use
“The safety and effectiveness of Felbatol in children other than those with Lennox-Gastaut syndrome has 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 Felbatol · Geriatric Use
“In general, dosage 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.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA020189
- DailyMed (FDA label)FDA Felbatol
- MedlinePlus (NIH)Felbamate
- WHO ATC/DDDN03AX10
- Darooyab (Iran)Felbamate
🇮🇷 Registered in Iran Darooyab · G-665/Felbamate
Dosage forms with Iranian generic codes, per Darooyab.
- 01504 · FELBAMATE 400MG TAB · قرص فلبامات ۴۰۰ میلیگرم
- 20731 · FELBAMATE 600MG TAB · قرص فلبامات ۶۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Felbatol · How SuppliedFDA Felbatol · Dosage and AdministrationFDA Felbatol · Boxed WarningFDA Felbatol · ContraindicationsFDA Felbatol · WarningsFDA Felbatol · SPL approval / marketing categoryFDA Felbatol · PregnancyFDA Felbatol · Nursing MothersFDA Felbatol · Pediatric UseFDA Felbatol · Geriatric Use
- 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-665/Felbamate
- Clinical review⚠ Unverified