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Eslicarbazepine acetate

ESLICARBAZEPINE ACETATE

Manufacturer: Camber Pharmaceuticals, Inc.

Score: 145.0

Quick Summary

Eslicarbazepine acetate is an antiepileptic drug used for the treatment of partial-onset seizures in patients 4 years of age and older. The recommended initial dosage is 400 mg once daily, with possible increases to 800-1600 mg once daily based on clinical response and tolerability. Important safety information includes warnings about suicidal behavior, serious dermatologic reactions, and drug interactions. Contraindications include hypersensitivity to eslicarbazepine acetate or oxcarbazepine. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of partial-onset seizures in patients 4 years of age and older
  • Extensively converted to eslicarbazepine, which is responsible for therapeutic effects
  • Inhibition of voltage-gated sodium channels is thought to be the mechanism of action

Important Safety Information

Warning

Suicidal behavior and ideation, serious dermatologic reactions, and drug interactions

Contraindications

  • Hypersensitivity to eslicarbazepine acetate or oxcarbazepine

Adverse Reactions

  • Dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor

Dosing Recommendations

General Guidance

Reduce dosage by 50% in patients with moderate or severe renal impairment

Partial-onset seizures

Adult Dose

400 mg once daily, with possible increases to 800-1600 mg once daily

Pediatric Dose

Based on body weight, with initial doses ranging from 200-400 mg once daily

Special Population Considerations

Pregnancy

  • Limited available data, use with caution
  • Pregnancy exposure registry available

Nursing Mothers

  • Use with caution, as eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives

Pediatric Use

  • Safety and effectiveness established in patients 4-17 years old
  • Use with caution in pediatric patients, as adverse reactions may be similar to those seen in adults

Geriatric Use

  • Pharmacokinetics not affected by age, but dose selection should consider renal impairment and other concomitant medical conditions
  • Dose adjustment necessary if CrCl is <50 mL/min

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