Literature Monitor

Aptiom Receives FDA approval for Partial-Onset Seizures in Children

Sunovion news release; 2017 Sept 14


FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.

Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.

Dosage and administration. The recommended dosage of APTIOM is based on

body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.

Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.

Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older Accessed October 16, 2017

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