Eslicarbazepine

Eslicarbazepine acetate 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.

• Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.ICD-10: G40.909

• Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2 , 5.3 , and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine.contraindicated

• Adult Patients: The recommended initial dosage of eslicarbazepine acetate 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 1,600 mg once daily. ( 2.2 ) • Pediatric Patients: The recommended dosage of eslicarbazepine acetate 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 ( 2.2 ). • Patients with Moderate or Severe Renal Impairment: Reduce dosage by 50%. ( 2.4 ) 2.1 Important Administration Instructions Instruct patients to administer eslicarbazepine acetate tablets either as whole or as crushed tablets. Instruct patients to take eslicarbazepine acetate tablets either with or without food. The eslicarbazepine acetate dosing regimen depends on age, weight, and renal function. 2.2 General Dosing Recommendations Monotherapy and Adjunctive Therapy Adult Patients The recommended initial dosage of eslicarbazepine acetate is 400 mg administered orally 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 during initiation [see Adverse Reactions ( 6.1 )] .

• Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior. ( 5.1 ) • Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established. ( 5.2 , 5.3 , 5.4 ) • Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms. ( 5.5 ) • 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. ( 5.6 ) • Withdrawal of eslicarbazepine acetate: Withdraw eslicarbazepine acetate gradually to minimize the risk of increased seizure frequency and status epilepticus. ( 2.6 , 5.7 , 8.1 ) • Drug Induced Liver Injury: Discontinue eslicarbazepine acetate tablets in patients with jaundice or evidence of significant liver injury. ( 5.8 ) • Hematologic Adverse Reactions: Consider discontinuing. ( 5.10 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including eslicarbazepine acetate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Serious Dermatologic Reactions [see Warnings and Precautions ( 5.2 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.4 )] • Hyponatremia [see Warnings and Precautions ( 5.5 )] • Neurological Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Drug Induced Liver Injury [see Warnings and Precautions ( 5.8 )] • Abnormal Thyroid Function Tests [see Warnings and Precautions ( 5.9 )] • Pancytopenia, Agranulocytosis, and Leukopenia [see Warnings and Precautions ( 5.10 )] • Most common adverse reactions in adult patients receiving eslicarbazepine acetate (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. ( 6.1 ) • Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as eslicarbazepine acetate, during pregnancy. Encourage women who are taking eslicarbazepine acetate during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary Limited available data with eslicarbazepine acetate use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see Data). Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the dose range of 400 mg to 1,600 mg once daily, both in healthy adult subjects and patients. The apparent half-life of eslicarbazepine in plasma was 13 to 20 hours in adult epilepsy patients.

10.1 Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Symptoms of overdose are consistent with the known adverse reactions of eslicarbazepine acetate and include hyponatremia (sometimes severe), dizziness, nausea, vomiting, somnolence, euphoria, oral paraesthesia, ataxia, walking difficulties, and diplopia. The maximum dosage studied in open-label adult monotherapy treatment following withdrawal of concomitant AEDs was 2,400 mg once daily. 10.2 Treatment or Management of Overdose There is no specific antidote for overdose with eslicarbazepine acetate. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered. Standard hemodialysis procedures result in partial clearance of eslicarbazepine acetate. Hemodialysis may be considered based on the patient’s clinical state or in patients with significant renal impairment.

• Nov 8, 2013NDANDA022416Sumitomo Pharma Am
• Jun 29, 2021ANDAANDA211238Dr Reddys
• Aug 3, 2023ANDAANDA211186Hetero Labs Ltd V
• Oct 6, 2023ANDAANDA211199Alkem Labs Ltd
• Dec 7, 2023ANDAANDA211236Apotex
• Feb 27, 2024ANDAANDA211227Torrent
• Mar 27, 2024ANDAANDA211246Lupin
• Aug 4, 2025ANDAANDA211219Jubilant Generics

1. 1Seizure98531%
2. 2Off Label Use3139.8%
3. 3Drug Ineffective2859.0%
4. 4Dizziness2146.7%
5. 5Somnolence1875.9%
6. 6Hyponatraemia1715.4%
7. 7Fatigue1514.7%
8. 8Headache1334.2%
9. 9Fall1153.6%
10. 10Generalised Tonic-clonic Seizure1133.6%
11. 11Nausea1003.1%
12. 12Therapy Interrupted983.1%
13. 13Rash973.1%
14. 14Condition Aggravated922.9%
15. 15Memory Impairment902.8%

The 10 most recently updated of 70 ClinicalTrials.gov registrations naming Eslicarbazepine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Anti-epileptogenic Effects of Eslicarbazepine Acetate
  Completed · Phase 2 · Interventional · 129 enrolled · Bial - Portela C S.A.
  NCT06597084updated 2025-05-02
• A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
  Completed · Phase 1 · Interventional · 32 enrolled · Bial - Portela C S.A.
  NCT02283814updated 2025-04-11
• Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
  Completed · Phase 1 · Interventional · 67 enrolled · Bial - Portela C S.A.
  NCT02283788updated 2025-04-11
• Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine
  Completed · Phase 1 · Interventional · 32 enrolled · Bial - Portela C S.A.
  NCT02281591updated 2025-04-08
• A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
  Completed · Phase 1 · Interventional · 18 enrolled · Bial - Portela C S.A.
  NCT01879345updated 2025-04-08
• Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
  Completed · Phase 1 · Interventional · 12 enrolled · Bial - Portela C S.A.
  NCT01679002updated 2025-04-06
• The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
  Completed · Phase 1 · Interventional · 13 enrolled · Bial - Portela C S.A.
  NCT02172742updated 2025-04-06
• Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
  Completed · Phase 3 · Interventional · 395 enrolled · Bial - Portela C S.A.
  NCT00957047updated 2025-03-25
• Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
  Completed · Phase 3 · Interventional · 402 enrolled · Bial - Portela C S.A.
  NCT00957684updated 2025-03-12
• Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
  Completed · Phase 3 · Interventional · 653 enrolled · Bial - Portela C S.A.
  NCT00988429updated 2021-05-19

Frequently asked questions

How does Eslicarbazepine work?

Eslicarbazepine acetate 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.

What is Eslicarbazepine used for?

According to FDA labeling, Eslicarbazepine carries indications including: Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Eslicarbazepine?

Eslicarbazepine is classified as Carboxamide derivatives, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers, Sodium Channel Antagonists, Decreased Central Nervous System Disorganized Electrical Activity.

What are the brand names for Eslicarbazepine?

Eslicarbazepine is marketed under brand names including Aptiom.

What are the contraindications for Eslicarbazepine?

Eslicarbazepine labeling lists contraindications including: Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2 , 5.3 , and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine.. Always consult the full prescribing information and a clinician.