Tablet (Aptiom / generic)
- Strengths
- 200, 400, 600, 800 mg
- Product note
- The product contains eslicarbazepine acetate, the prodrug. Profile name denotes the active therapy. No commercial U.S. oral liquid identified; label allows crushing tablets.
Eslicarbazepine
Aptiom
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Aptiom: focal-onset (partial-onset) seizures from age 4 years.
- Role
- Maintenance
- Class
- Active sodium-channel modulator; administered as the acetate prodrug
Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Aptiom tablet U.S. label
Focal seizures · 4 years and older · Maintenance
Formulations & strengths
U.S. products unless another country is named. Strengths are per unit or stated volume.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- 400 mg once daily, then 800–1,600 mg once daily.
- Pediatric
- Age ≥4 years: weight-based once-daily dosing.
- Titration / repeat dosing
- Adults: 400 mg once daily; after 1 week increase to 800 mg daily. If needed, increase by 400–600 mg at weekly intervals to 1,200–1,600 mg daily. Pediatric titration is weight based, no more often than weekly.
- Dose basis
- All doses below refer to the marketed eslicarbazepine acetate formulation (Aptiom).
Dose adjustment & concentrations
- Renal impairment
- Reduce initial and maintenance dose by 50% when CrCl <50 mL/min.
- Hepatic impairment
- No adjustment mild–moderate; not studied severe.
- Serum reference information
- No established therapeutic range
Safety
- Boxed warning
- No boxed warning.
- Contraindications
- Hypersensitivity to eslicarbazepine acetate or oxcarbazepine.
- Serious precautions & monitoring
- Monitor sodium when indicated; clinically significant hyponatremia can worsen seizures. Serious rash, DRESS, anaphylaxis/angioedema, liver injury and hematologic abnormalities require evaluation. Dose-related dizziness, ataxia and visual effects.
Common / selected adverse effects
- Dizziness
- Somnolence
- Nausea
- Headache
- Diplopia
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Phenytoin / other CYP2C19 substrates | Eslicarbazepine inhibits CYP2C19; phenytoin can rise and cause ataxia/diplopia. | Monitor phenytoin and adjust if toxicity occurs. |
| Carbamazepine or other enzyme-inducing ASMs | Lower eslicarbazepine exposure; carbamazepine also increases dizziness/diplopia. | Review both doses and tolerability. Do not coadminister with oxcarbazepine. |
| Hormonal contraceptives | Reduced estrogen/progestin exposure. | Use additional/alternative nonhormonal contraception. |
Pregnancy & contraception
- Fetal / neonatal risk
- Human pregnancy data for eslicarbazepine acetate are insufficient to define risk. Animal studies found malformations, embryofetal loss and impaired fetal growth at clinically relevant doses.
- Contraception
- Aptiom reduces ethinylestradiol/levonorgestrel exposure. Use additional or alternative nonhormonal contraception during treatment and for at least one menstrual cycle after stopping, as directed by the label.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Direct pivotal trial
Trial summary
- Study design / duration
- Three randomized, double-blind, placebo-controlled adjunctive trials in adults with focal seizures; 8-week baseline, 2-week titration, and 12-week maintenance.
- Primary endpoint
- No single pivotal endpoint is identified in the cited source.
- Results
- Three pivotal adjunctive focal-seizure trials showed median seizure-frequency reductions of roughly 32–35% at 800 mg and 35–39% at 1,200 mg versus 15–21% with placebo.
Trial publications
Mechanism of action
- Drug identity: eslicarbazepine is the active S-licarbazepine molecule. Aptiom contains eslicarbazepine acetate, an ester prodrug hydrolyzed to eslicarbazepine.
- Target: voltage-gated sodium channels. Inhibition of sodium-channel activity is thought to limit repetitive neuronal firing; the precise human antiseizure mechanism remains incompletely established.
- Relationship: oxcarbazepine produces both S- and R-licarbazepine (collectively MHD). The acetate prodrug produces predominantly S-licarbazepine. These products have different dosing and are not interchangeable milligram for milligram.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- The administered acetate prodrug is well absorbed and rapidly hydrolyzed; >90% of the dose is recovered in urine as eslicarbazepine-related material. A separate absolute bioavailability for administered active eslicarbazepine is not specified.
- Elimination half-life
- Active eslicarbazepine: 13–20 hours in adults with epilepsy; 10–16 hours in pediatric patients.
- Volume of distribution
- Apparent volume for active eslicarbazepine approximately 61 L in a 70-kg patient (population PK).
- Active metabolite(s)
- Eslicarbazepine IS the principal active product of the administered acetate prodrug (~91% of systemic exposure). Minor active products of that prodrug are R-licarbazepine (~5%) and oxcarbazepine (~1%).
- Active-metabolite half-life
- Principal active eslicarbazepine: 13–20 hours in adults. Separate half-lives for the minor active products after Aptiom are not reported in the cited label.
- Protein binding
- <40%
- Metabolism / elimination
- Acetate prodrug → eslicarbazepine by hydrolysis; subsequent glucuronidation and renal elimination.
The profile is named for active eslicarbazepine; it must not be described as converting to itself. Renal function affects its clearance.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- 2013
- Brands
- Aptiom
- Manufacturer / marketer
- Sunovion/Sumitomo Pharma America (Aptiom)
- Generic availability
- Yes; market availability varies
- Related drugs
- Eslicarbazepine (S-licarbazepine) is also the predominant component of oxcarbazepine’s active MHD mixture. Carbamazepine is structurally related.
Sources & review status
Representative sources are selected product labels, not an exhaustive list of generic manufacturers. Consult the exact product and formulation prescribed. Brand-name package inserts are linked separately.
Brand reference: Aptiom ↗
Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 3/2019. This is a draft reference; final review is pending.