Clinical Information
Gen. Code and Des.
72032 eslicarbazepine acetate ORAL TABLET 600 MG
GCN and Des.
36106 eslicarbazepine acetate ORAL TABLET 600 MG
Strength
600MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28129200 ANTICONVULSANTS, MISCELLANEOUS
Active Ingredients
13277 eslicarbazepine acetate 236395145
Inactive Ingredients
These highlights do not include all the information needed to use APTIOM safely and effectively. See full prescribing information for APTIOM.
APTIOM® (eslicarbazepine acetate) tablets, for oral use
Initial U.S. Approval: 2013
INDICATIONS AND USAGE
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. (1)
DOSAGE AND ADMINISTRATION
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. (2.2)
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. (2.2)
Patients with Moderate or Severe Renal Impairment: Reduce dosage by 50%. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, 400 mg, 600 mg, 800 mg (3)
CONTRAINDICATIONS
Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. (4)
WARNINGS AND PRECAUTIONS
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 APTIOM: Withdraw APTIOM gradually to minimize the risk of increased seizure frequency and status epilepticus. (2.6, 5.7, 8.1)
Drug Induced Liver Injury: Discontinue APTIOM in patients with jaundice or evidence of significant liver injury. (5.8)
Hematologic Adverse Reactions: Consider discontinuing. (5.10)
ADVERSE REACTIONS
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. (6.1)
Adverse reactions in pediatric patients are similar to those seen in adult patients.
To report SUSPECTED ADVERSE REACTIONS, contact Sunovion at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carbamazepine: May need dose adjustment for APTIOM or carbamazepine. (2.3, 5.6, 7.1)
Phenytoin: Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin. (2.3, 7.1, 7.2)
Phenobarbital or Primidone: Higher dosage of APTIOM may be necessary. (2.3, 7.1)
Hormonal Contraceptives: APTIOM may decrease the effectiveness of hormonal contraceptives. (7.4, 8.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2019