Adjunctive treatment of partial-onset seizures w/ or w/o secondarily generalised seizures in patients ≥12 yr w/ epilepsy & primary generalised tonic-clonic seizures in patients ≥12 yr w/ idiopathic generalised epilepsy.
Adult & adolescent Partial-onset seizuresInitially 2 mg daily at bedtime. May be increased by increments of 2 mg (either wkly or every 2 wk) to a maintenance dose of 4-8 mg daily, w/ 1 wk interval between dose increases. Max dose: 12 mg daily. Primary generalised tonic-clonic seizures Initially 2 mg daily at bedtime. May be increased by increments of 2 mg (either wkly or every 2 wk) to a maintenance dose of 8 mg daily, w/ 1 wk interval between dose increases. Then, may be further increased up to 12 mg daily. Patient w/ mild & moderate hepatic impairment Initially 2 mg daily. Dose up titration: 2 mg doses no faster than every 2 wk. Max: 8 mg daily.
Monitor for signs of suicidal ideation & behaviours. Severe cutaneous adverse reactions (SCARs) including drug reaction w/ eosinophilia & systemic symptoms (DRESS), aggression & hostile behavior. Monitor closely patients for skin reactions. Discontinue if drug reaction w/ eosinophilia & systemic symptoms (DRESS) occurs. May decrease effectiveness of progestative-containing hormonal contraceptives. Increased risk of falls particularly in the elderly. Reduce dose or discontinue if there is significant changes in mood or behavioural pattern. Patients w/ history of substance abuse & monitor for symptoms of drug abuse. Lower response rates in concomitant use w/ CYP3A enzyme-inducing drugs (carbamazepine, phenytoin, oxcarbazepine); decreased or increased plasma levels w/ other CYP450 inducers or inhibitors. Monitor patients response when switching from concomitant non-inducer anti-epileptic to enzyme inducing drugs or vice versa. Monitor closely patients for tolerability & clinical response when adding or removing CYP450 inducers or inhibitors. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause dizziness & somnolence & therefore may influence the ability to drive or use machines. Not recommended in patients w/ moderate or severe renal impairment or undergoing haemodialysis & severe hepatic impairment. Not recommended in women of childbearing potential not using contraception. Not recommended during pregnancy. Lactation. Childn <12 yr. Elderly ≥65 yr.
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