Concise Prescribing Info
Adjunctive treatment of seizures associated w/ Lennox-Gastaut syndrome in adults & ped patients ≥1 yr.
Dosage/Direction for Use
Adult ≥17 yr Initially 400-800 mg/day in 2 equally divided doses. Should be increased by 400-800 mg every other day. Max daily dose: 3,200 mg in 2 equally divided doses. Ped patients 1 yr to <17 yr Initially approx 10 mg/kg in 2 equally divided doses. Should be increased by approx 10 mg/kg increments every other day. Max daily dose: 45 mg daily, not to exceed 3,200 mg in 2 equally divided doses. Patients taking valproate Adult Initially 400 mg daily. Childn <10 mg/kg daily.
Should be taken with food: For patients w/ swallowing difficulties, tab may be halved or crushed.
Special Precautions
Increased risk of suicidal thoughts or behavior. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior &/or unusual changes in mood or behavior. CNS reactions. Familial short QT syndrome. Concomitant use w/ drugs that shorten QT interval. Discontinue if drug reaction w/ eosinophilia & systemic symptoms is suspected. W/draw gradually; close medical supervision in transition to another epileptic drug if abrupt discontinuation of Inovelon is necessary. Leukopenia. Severe hepatic (Child-Pugh score 10-15) impairment; mild (Child-Pugh score 5-6) to moderate (Child-Pugh score 7-9) hepatic impairment. May impair ability to drive or operate machinery. Pregnancy & lactation. Ped patients <1 yr.
Adverse Reactions
Headache, dizziness, fatigue, somnolence & nausea; diplopia, ataxia, upper abdominal pain. Adults: Tremor, nystagmus, blurred vision, vomiting, anxiety, constipation, dyspepsia, back pain, gait disturbance, vertigo. Ped patients: Influenza, nasopharyngitis, decreased appetite, rash, bronchitis, sinusitis, psychomotor hyperactivity, aggression, ear infection, disturbance in attention, pruritis.
Drug Interactions
Decreased conc w/ carbamazepine, lamotrigine & primidone. May decrease conc of carbamazepine & lamotrigine. May increase conc of phenobarb & phenytoin. Increased conc w/ valproate.
MIMS Class
ATC Classification
N03AF03 - rufinamide ; Belongs to the class of carboximide derivatives antiepileptic. Used in the management of epilepsy.
Inovelon FC tab 200 mg
6 × 10's
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