Oxcarbazepine

DRUG INFORMATION

  ADULT
    - Adults : Initiate with a dose of 600 mg/day, given twice a day • Adjunctive
      Therapy: Maximum increment of 600 mg/day at approximately weekly intervals.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'dosage and
      administration', retrieved 2026-08-29
    - For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20
      mg/kg/day may be considered.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'dosage and
      administration', retrieved 2026-08-29
    - If clinically indicated, the dose may be increased by a maximum of 600 mg/day at
      approximately weekly intervals; the maximum recommended daily dose is 1,200
      mg/day.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Oxcarbazepine is indicated for use as adjunctive therapy for partial-onset
      seizures in patients aged 2 to 16 years. The safety and effectiveness for use as
      adjunctive therapy for partial-onset seizures in pediatric patients below the age
      of 2 have not been established. Oxcarbazepine is also indicated as monotherapy for
      partial-onset seizures in patients aged 4 to 16 years.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'pediatric use',
      retrieved 2026-08-29
    - For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20
      mg/kg/day may be considered.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'dosage and
      administration', retrieved 2026-08-29
    - Controlled trials in these patients examined the effectiveness of a 1,200 mg/day
      dose; a dose of 2,400 mg/day has been shown to be effective in patients converted
      from other AEDs to oxcarbazepine oral suspension monotherapy (see above).
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Comparisons of creatinine clearance in young and elderly volunteers indicate that
      the difference was due to age-related reductions in creatinine clearance.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'use in specific
      populations', retrieved 2026-08-29
    - Close monitoring of sodium levels is required in elderly patients at risk for
      hyponatremia [se e Warnings and Precautions (5.1) ]. 8.6 Renal Impairment Dose
      adjustment is recommended for renally impaired patients (creatinine clearance < 30
      mL/min) [see Dosage and Administration (2.7) and Clinical Pharmacology (12.3) ].
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for oxcarbazepine (OXCARBAZEPINE),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Although oxcarbazepine is closely related structurally to
      carbamazepine, which is considered to be teratogenic in humans, available human
      data from published literature and ongoing pregnancy registry studies on use of
      oxcarbazepine during pregnancy have not demonstrated an increased prevalence of
      major congenital malformationswith first trimester exposure.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'pregnancy',
      retrieved 2026-08-29
    - However, all published studies reviewed have important methodological limitations,
      including unmeasured confounding and a small number of exposed cases (see Data).
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'pregnancy',
      retrieved 2026-08-29
    - There are risks to the mother and fetus associated with partial onset seizures
      (see Clinical Considerations).
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Contraception Use of oxcarbazepine with hormonal contraceptives containing
      ethinylestradiol or levonorgestrel is associated with decreased plasma
      concentrations of these hormones and may result in a failure of the therapeutic
      effect of the oral contraceptive drug.
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'nursing mothers',
      retrieved 2026-08-29
    - Advise women of reproductive potential taking oxcarbazepine who are using a
      contraceptive containing ethinylestradiol or levonorgestrel to use additional or
      alternative non-hormonal birth control [see Drug Interactions (7.3) and Clinical
      Pharmacology (12.3) ].
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'nursing mothers',
      retrieved 2026-08-29
    - In a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50,
      or 150 mg/kg/day) during the latter part of gestation and throughout the lactation
      period, a persistent reduction in body weights and altered behavior (decreased
      activity) were observed in offspring exposed to the highest dose (less than the
      MRHD on a mg/m 2 basis).
      Source: US FDA label for oxcarbazepine (OXCARBAZEPINE), section 'use in specific
      populations', retrieved 2026-08-29