Inovelon

Inovelon

rufinamide

Manufacturer:

Eisai

Distributor:

DKSH

Marketer:

Eisai
Concise Prescribing Info
Contents
Rufinamide
Indications/Uses
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.
Administration
Should be taken with food: For patients w/ swallowing difficulties, tab may be halved or crushed.
Contraindications
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.
Presentation/Packing
Form
Inovelon FC tab 200 mg
Packing/Price
6 × 10's
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