Concise Prescribing Info
Adjunctive treatment of seizures associated w/ Lennox-Gaustaut syndrome in adults & childn ≥4 yr.
Dosage/Direction for Use
Adult, adolescent & childn ≥4 yr, ≥30 kg Initially 400 mg daily, may be increased by 400 mg daily increments every 2 days. Max: ≥70.1 kg 3,200 mg daily, 50.1-70 kg 2,400 mg daily, 30-50 kg 1,800 mg daily. Childn ≥4 yr & <30 kg not receiving valproate Initially 200 mg daily, may be increased by 200 mg daily increments every 2 days up to max: 1,000 mg daily. <30 kg receiving valproate Initially 200 mg daily, may be increased by 200 mg daily after 2 days to max: 600 mg daily.
Should be taken with food: For patients w/ swallowing difficulties, tab may be halved/crushed.
Hypersensitivity to triazole derivatives.
Special Precautions
Hypersensitivity syndrome. Development &/or increased frequency of new seizure type. Monitor for signs of suicidal ideation & behaviours. Increase occurrence of falls. Congenital short QT syndrome. Avoid abrupt w/drawal. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Mild to moderate hepatic impairment. Not recommended in severe hepatic impairment. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Lactation. Childn <4 yr.
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. Reduced plasma conc of substances metabolised by CYP3A4 enzymes.
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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