Concise Prescribing Info
Adjunctive therapy in the treatment of seizures associated w/ Lennox-Gastaut syndrome in patients ≥4 yr.
Dosage/Direction for Use
Adult, adolescent & childn ≥4 yr, ≥30 kg Initially 400 mg daily, may be increased by 400 mg/day increments every 2 days. Max: ≥70.1 kg 3,200 mg/day, 50.1-70 kg 2,400 mg/day, 30-50 kg 1,800 mg/day. Patient >30 kg receiving valproate Initially 400 mg daily, may be increased by 400 mg/day increments every other day. Max: ≥70.1 kg 2,200 mg/day, 50.1-70 kg 1,600 mg/day, 30-50 kg 1,200 mg/day. Childn ≥4 yr & <30 kg not receiving valproate Initially 200 mg daily, may be increased by 200 mg/day increments every 2 days up to max of 1,000 mg/day. <30 kg receiving valproate Initially 200 mg daily, may be increased by 200 mg/day after 2 days to max of 600 mg/day.
Should be taken with food: For patients w/ swallowing difficulties, tab may be halved or crushed.
Hypersensitivity to rufinamide or triazole derivatives.
Special Precautions
Status epilepticus. W/draw gradually to reduce the possibility of seizures on w/drawal. Associated w/ dizziness, somnolence, ataxia & gait disturbances. Serious antiepileptic drug hypersensitivity syndrome including drug reaction w/ eosinophilia & systemic symptoms (DRESS) & Stevens-Johnson syndrome. Lymphadenopathy, liver function test abnormalities & hematuria. Discontinue use & start alternative treatment if antiepileptic drug hypersensitivity syndrome is suspected. Decreased in QTc interval proportional to conc. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Monitor for signs of suicidal ideation & behaviour. May cause minor to major influence on the ability to drive & use machinery. Patients w/ mild to moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment. Women of childbearing potential must use effective contraception during treatment. Should not be used during pregnancy. Avoid breast-feeding during treatment.
Adverse Reactions
Somnolence, headache, dizziness; nausea, vomiting; fatigue. Pneumonia, influenza, nasopharyngitis, ear infection, sinusitis, rhinitis; anorexia, eating disorder, decreased appetite; anxiety, insomnia; status epilepticus, convulsion, abnormal coordination, nystagmus, psychomotor hyperactivity, tremor; diplopia, blurred vision; vertigo; epistaxis; upper abdominal pain, constipation, dyspepsia, diarrhoea; rash, acne; back pain; oligomenorrhoea; gait disturbance; decreased wt; head injury, contusion.
Drug Interactions
Increased plasma conc w/ valproate. Decreased ethinylestradiol & norethindrone AUC w/ OCs. Reduced plasma conc of substances metabolised by CYP3A4 enzymes. Concomitant use w/ warfarin & digoxin.
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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