Uses
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Source: US FDA prescribing information
- Presentations
- 9
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Eslicarbazepine is a prescription medicine indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It is available as tablets and kits for oral use. MedsAcross supplies Eslicarbazepine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers, Decreased Central Nervous System Disorganized Electrical Activity
- ATC classification
- N03AF04 Eslicarbazepine · Anticonvulsant agent, subgroup N03AF
- US FDA first approval
- 8 November 2013
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Kit
- Identifiers
- UNII S5VXA428R4RxCUI 1482502CAS 104746-04-5DrugBank DB14575Q27077226
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
APTIOM is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
Source: US FDA prescribing information
Dosing overview
Adult Patients: The recommended initial dosage of APTIOM is 400 mg once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions. Increase the dose in weekly increments of 400 mg to 600 mg once daily, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1600 mg once daily. Pediatric Patients: The recommended dosage of APTIOM is based on body weight and is administered orally once daily. Increase the dose in weekly intervals based on clinical response and tolerability, to the recommended maintenance dosage. Patients with Moderate or Severe Renal Impairment: Reduce dosage by 50%.
Source: US FDA prescribing information
Contraindications
APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine.
Source: US FDA prescribing information
Warnings and precautions
Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior. Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established. Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms. Neurological Adverse Reactions: Monitor for dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes. Use caution when driving or operating machinery. Withdrawal of APTIOM: Withdraw APTIOM gradually to minimize the risk of increased seizure frequency and status epilepticus. Drug Induced Liver Injury: Discontinue APTIOM in patients with jaundice or evidence of significant liver injury. Hematologic Adverse Reactions: Consider discontinuing.
Source: US FDA prescribing information
Side effects
The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Suicidal Behavior and Ideation Serious Dermatologic Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Anaphylactic Reactions and Angioedema Hyponatremia Neurological Adverse Reactions Drug Induced Liver Injury Abnormal Thyroid Function Tests Pancytopenia, Agranulocytosis, and Leukopenia Most common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions in pediatric patients are similar to those seen in adult patients.
Source: US FDA prescribing information
Interactions
Carbamazepine: May need dose adjustment for APTIOM or carbamazepine. Phenytoin: Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin. Phenobarbital or Primidone: Higher dosage of APTIOM may be necessary. Hormonal Contraceptives: APTIOM may decrease the effectiveness of hormonal contraceptives.
Source: US FDA prescribing information
Storage
Store APTIOM tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
9 presentations of Eslicarbazepine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Eslicarbazepine 600 mg tabletOralGeneric name | — | US FDA | Available on request |
| Eslicarbazepine 800 mg tabletOralGeneric name | — | US FDA | Available on request |
| Eslicarbazepine 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Eslicarbazepine 400 mg tabletOralGeneric name | — | US FDA | Available on request |
| Aptiom 200 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
| Aptiom 400 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
| Aptiom 600 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
| Aptiom 800 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
| Aptiom kitOral | Sumitomo Pharma | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Eslicarbazepine available for export from India?
Yes, on request. MedsAcross lists 9 presentations of Eslicarbazepine and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Eslicarbazepine have?
The catalogue lists 1 brand names for Eslicarbazepine, including Aptiom.
Is Eslicarbazepine approved by the US FDA?
Yes. The US FDA first approved Eslicarbazepine on 8 November 2013, according to Drugs@FDA.
Is Eslicarbazepine authorised in the European Union?
Yes. Eslicarbazepine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Eslicarbazepine need cold chain shipping?
No listed presentation of Eslicarbazepine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Eslicarbazepine in?
Eslicarbazepine is classified under ATC code N03AF04 (Eslicarbazepine).
References
- Aptiom prescribing information (Sumitomo Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 10 November 2023
- Zebinix: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 August 2026
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