Agencia Lei Va Hong
Concise Prescribing Info
Adjunctive therapy in the treatment of seizures associated w/ Lennox-Gastaut syndrome in patient ≥4 yr.
Dosage/Direction for Use
Adult, adolescent & childn ≥4 yr (≥30 kg) Initially 400 mg daily dose, may be increased by 400 mg/day as frequently as 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. Childn ≥4 yr, <30 kg not receiving valproate Initially 200 mg daily, may be increased by 200 mg/day increments as frequently as every 2 days. Max: 1,000 mg/day; <30 kg also receiving valproate medication Initially 200 mg daily dose. After a min of 2 days, dose may be increased by 200 mg/day. Max: 600 mg/day.
Should be taken with food: Take in the morning & evening w/ water. For patients w/ swallowing difficulties, crush tab & administer in ½ glass of water.
Hypersensitivity to rufinamide or triazole derivatives.
Special Precautions
Status epilepticus. W/draw or 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 & haematuria. Discontinue use & start alternative treatment if reaction is suspected. Decrease in QTc interval proportional to conc. Women of childbearing potential. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Monitor for signs of suicidal ideation & behaviour. Hepatic impairment. Lactation. Elderly >65 yr. 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
Significant increase of plasma conc w/ valproate. Decreased AUC of ethinyl estradiol & norethindrone. Reduced plasma conc of substances metabolised by CPY3A4.
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
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