Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults & adolescents ≥16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn ≥4 yr w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy & primary generalized tonic-clonic seizures in adults & childn ≥4 yr w/ idiopathic generalized epilepsy.
Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Add-on therapyAdult (≥18 yr) & adolescent (12-17 yr) ≥50 kg Initially 500 mg bid, may be increased up to 1,500 mg bid. Dose may be increase or decrease to 500 mg bid every 2-4 wk. Childn & adolescent ≥50 kg Adult dose, 4-17 yr <50 kg Initially 10 mg/kg bid, may be increased up to 30 mg/kg bid. Dose increment/decrement should not be >10 mg/kg bid every 2 wk. Oral solnChildn ≤20 kg Initially 100 mg/mL.
Avoid abrupt w/drawal. Monitor for signs of depression &/or suicidal ideation & behaviors. Renal & severe hepatic impairment. Contains sunset yellow lake (tab) & methyl & propyl parahydroxybenzoate (oral soln) which may cause allergic reactions. May impair ability to drive or operate machinery. Pregnancy & lactation. Infants <1 yr w/ epilepsy. Childn <6 yr (tab), <4 yr & infants (infusion conc). Elderly. Oral soln: Rare hereditary problems of fructose intolerance (due to maltitol content) & may cause headache, stomach upset & diarrhea (due to glycerol content). Soln for infusion: Patients on controlled Na diet.