Eslicarbazepine acetate
اسلیکاربازپین
🧠 Nervous SystemAntiseizure (sodium-channel blocker)
Market / country: 🇺🇸 USA
Aptiom (US)
🧮 Dose calculator
Epilepsy (complex partial / absence seizures) · Regimen source: FDA Aptiom · 2.2
- • Start 400 mg (or 800 mg if needed); increase weekly by 400–600 mg. Not with oxcarbazepine. FDA Aptiom · 2.2FDA Aptiom · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. FDA Aptiom · 4
Warnings
- • Suicidal thoughts and behaviour; do not stop abruptly (seizures, status epilepticus). FDA Aptiom · 5.1
- • Serious skin reactions and DRESS; anaphylaxis; hyponatraemia; dizziness and gait disturbance; liver injury. Not recommended in severe hepatic impairment. FDA Aptiom · 5FDA Aptiom · 2.5
Renal adjustment
- • eGFR < 50: CrCl <50: reduce initial, titration and maintenance doses by 50%. FDA Aptiom · 2.4
Formulations
- 800 mg tablet (scored) — tablet 🇺🇸 USA FDA Aptiom · 3
- 400 mg tablet — tablet 🇺🇸 USA FDA Aptiom · 3
- 200 mg tablet (scored) — tablet 🇺🇸 USA FDA Aptiom · 3
- 600 mg tablet (scored) — tablet 🇺🇸 USA FDA Aptiom · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Aptiom · 8.1
“Risk Summary Limited available data with APTIOM use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Aptiom · 8.2
“Eslicarbazepine is present in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Aptiom · 8.4
“Safety and effectiveness of APTIOM have been established in the age groups 4 to 17 years.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Aptiom · 8.5
“Although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Aptiom · 8.3
“Contraception Use of APTIOM with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones.”
🔗 Reference links
- FDA (approval record)NDA022416
- DailyMed (FDA label)FDA Aptiom
- MedlinePlus (NIH)Eslicarbazepine
- WHO ATC/DDDN03AF04
- 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 Aptiom · 3FDA Aptiom · 2.2FDA Aptiom · 2.3FDA Aptiom · 2.2, Table 1FDA Aptiom · 4FDA Aptiom · 5.1FDA Aptiom · 5FDA Aptiom · 2.5FDA Aptiom · 2.4FDA Aptiom · SPL approval / marketing categoryFDA Aptiom · 8.1FDA Aptiom · 8.2FDA Aptiom · 8.4FDA Aptiom · 8.5FDA Aptiom · 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