Section 01 · Monograph
Eslicarbazepine
Reviewed Nov 2026FDA label
AptiomNa+ channel blocker
- Forms
- Tab: 200, 400, 600, 800mg
- Dose
- 400-1600mg once daily
- MOA
- Blocks voltage-gated Na+ channels
Indications
- Treatment of partial-onset seizures (monotherapy or adjunctive) in patients age 4 years and olderFDA-labeled
Mechanism of Action
- Prodrug rapidly hydrolyzed to eslicarbazepine, the same major active metabolite produced by oxcarbazepine (via the S-enantiomer of the monohydroxy derivative)
- Blocks voltage-gated Na+ channels, stabilizing their inactivated state and reducing repetitive neuronal firing
Full Dosing
Adult / usual
- Once-daily dosing is a distinguishing practical feature versus oxcarbazepine/carbamazepine, which supports adherence
- Adults: initiate 400mg once daily, increase by 400–600mg at weekly intervals as needed to a usual maintenance range of 800–1600mg once daily
Renal
- Dose adjustment required in renal impairment; lower maximum doses recommended with reduced CrCl
Hepatic
- Dose adjustment/caution advised in hepatic impairment
Pediatric
- Pediatric dosing (age 4–17) is weight-based, also administered once daily
Contraindications
- Known hypersensitivity to eslicarbazepine acetate or to oxcarbazepine (cross-reactivity)
Drug Interactions
- Cross-hypersensitivity risk with oxcarbazepine (contraindicated) and possible cross-reactivity with carbamazepine
- Moderate CYP3A4 induction reduces efficacy of hormonal contraceptives — alternative or additional contraception recommended
- Inhibits CYP2C19, which may increase phenytoin concentrations
- Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin) can reduce eslicarbazepine exposure, potentially requiring a higher dose
Adverse Effects
- Common: dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, tremor
- Hyponatremia, dose-related — clinically significant hyponatremia (<125mEq/L) occurred in roughly 1–1.5% of patients on higher doses in controlled trials versus none on placebo
- Serious dermatologic reactions and multiorgan hypersensitivity reactions
- Suicidal ideation/behavior — monitor for new or worsening depression or mood changes
Monitoring Parameters
- Serum sodium in patients at risk for hyponatremia (e.g., concurrent sodium-lowering medications, renal impairment) or with suggestive symptoms
- Signs of hypersensitivity reaction, especially with prior oxcarbazepine or carbamazepine sensitivity
- Renal and hepatic function for dose adjustment
Pregnancy & Lactation
- Limited human pregnancy data; animal studies show developmental toxicity at clinically relevant exposures
- Consider enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry
- Unknown whether present in human breast milk; detected in animal milk — weigh benefits of breastfeeding against potential infant exposure