Contraindicated in:
- Hypersensitivity to oxcarbazepine, carbamazepine, or eslicarbazepine.
Use Cautiously in:
- All patients (may ↑ risk of suicidal thoughts/behaviors)
- Renal impairment (dose ↓ recommended if CCr <30 mL/min)
- Severe hepatic impairment
- Rep: Women of reproductive potential
- OB: May be teratogenic (associated with oral clefts and cardiac abnormalities); levels of active metabolites may gradually ↓ during pregnancy which may ↑ seizure risk; use during pregnancy only if potential maternal benefit justifies potential fetal risk
- Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
- Pedi: Safety and effectiveness not established in children <2 yr (immediate-release) or <6 yr (extended-release)
- Geri: Appears on Beers list. May worsen or cause syndrome of inappropriate antidiuretic hormone (SIADH) secretion in older adults. Use with caution in older adults and closely monitor sodium concentrations when starting therapy or ↑ dose.
Exercise Extreme Caution in:
- Patients positive for HLA-B*1502 alleles (unless benefits clearly outweigh the risks) (↑ risk of serious skin reactions).
Derm: acne, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, urticaria.
EENT: abnormal vision, diplopia, nystagmus.
Endo: SIADH, hypothyroidism.
F and E: ↑thirst, hyponatremia.
GI: abdominal pain, nausea, vomiting, dyspepsia.
Hemat: lymphadenopathy.
Neuro: ataxia, dizziness, drowsiness, gait disturbances, headache, tremor, vertigo, cognitive symptoms, SEIZURES, SUICIDAL THOUGHTS.
Misc: hypersensitivity reactions.
(Immediate-release tablets and oral suspension can be interchanged at equal doses.)
- PO (Adults): Adjunctive therapy (immediate-release): 300 mg twice daily, may ↑ by up to 600 mg/day at weekly intervals up to 1200 mg/day (up to 2400 mg/day may be needed); Conversion to monotherapy (immediate-release): 300 mg twice daily; may ↑ by 600 mg/day at weekly intervals, while other antiepileptic drugs are tapered over 36 wk; dose of oxcarbazepine should be ↑ up to 2400 mg/day over a period of 24 wk; Initiation of monotherapy (immediate-release): 300 mg twice daily, ↑ by 300 mg/day every 3rd day, up to 1200 mg/day. Maximum maintenance dose should be achieved over 24 wk; Adjunctive therapy or monotherapy (extended-release): 600 mg once daily for 1 wk; may ↑ by 600 mg/day at weekly intervals up to 12002400 mg once daily; Concurrent use of strong CYP3A4 inducer (carbamazepine, phenobarbital, phenytoin, rifampin) (extended-release): consider initiating therapy with 900 mg once daily.
- PO (Children 216 yr): Adjunctive therapy (immediate-release): 45 mg/kg twice daily (up to 600 mg/day), ↑ over 2 wk to achieve 900 mg/day in patients 2029 kg, 1200 mg/day in patients 29.139 kg and 1800 mg/day in patients >39 kg (range 651 mg/kg/day). In patients <20 kg, initial dose of 1620 mg/kg/day may be used not to exceed 60 mg/kg/day. Conversion to monotherapy (immediate-release): 810 mg/kg/day given twice daily; may ↑ by 10 mg/kg/day at weekly intervals, whereas other antiepileptic drugs are tapered over 36 wk; dose of oxcarbazepine should be ↑ up to 600900 mg/day in patients 20 kg, 9001200 mg/day in patients 2530 kg, 9001500 mg/day in patients 3540 kg. 12001500 mg/day in patients 45 kg, 12001800 mg/day in patients 5055 kg, 12002100 mg/day in patients 6065 kg, and 15002100 mg/day in patients 70 kg. Maximum maintenance dose should be achieved over 24 wk.
- PO (Children 617 yr): Adjunctive therapy or monotherapy (extended-release): 810 mg/kg once daily (up to 600 mg/day) for 1 wk; may ↑ by 810 mg/kg/day at weekly intervals over 23 wk to achieve 900 mg/day in patients 2029 kg, 1200 mg/day in patients 29.139 kg and 1800 mg/day in patients >39 kg; Concurrent use of strong CYP3A4 inducer (carbamazepine, phenobarbital, phenytoin, rifampin) (extended-release): consider initiating therapy with 1215 mg/kg (max dose = 900 mg) once daily.
Renal Impairment
- PO (Adults): CCr<30 mL/min (immediate- and extended-release). Initiate therapy at 300 mg/day and ↑ slowly to achieve desired response.
Therapeutic Classification: anticonvulsants
Pharmacologic Classification: carbamazepine analogues
Absorption: Rapidly absorbed after oral administration and rapidly converted to the active 10-hydroxy metabolite (MHD).
Distribution: Extensively distributed to tissues.
Metabolism/Excretion: Extensively converted to the active metabolite, MHD, which is then primarily excreted by the kidneys.
Half-life: Oxcarbazepine: 2 hr; MHD: 9 hr.
(blood levels)
Steady-state levels of MHD are reached after 23 days during twice-daily dosing.