Inovelon

Inovelon

rufinamide

Manufacturer:

Eisai

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rufinamide
Indications/Uses
Adjunctive treatment of seizures associated w/ Lennox-Gastaut syndrome in adults & childn ≥4 yr.
Dosage/Direction for Use
Adult, adolescent & childn (≥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. Adult & childn (<30 kg) Initially 200 mg daily, may be increased by 200 mg/day increments as frequently as every 2 days. Max: 1,000 mg/day; patient taking valproate Initially 200 mg daily dose. After a min of 2 days, dose may be increased by 200 mg/day. Max: 600 mg/day.
Administration
Should be taken with food: If patient has difficulty w/ swallowing, tab can be crushed & administered in half a glass of water.
Contraindications
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. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Monitor for signs of suicidal ideation & behaviour. Mild to moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment. May influence the ability to drive or operate machinery. Women of childbearing potential must use effective contraception during treatment. Pregnancy & lactation. Elderly >65 yr. Newborn infants or infants & toddlers <2 yr.
Adverse Reactions
Somnolence, vomiting, fatigue, decreased appetite, nasopharyngitis, headache, rash, rhinitis, ataxia, psychomotor activity, convulsion, ear infection, epistaxis, nystagmus, status epilepticus, contusion, head injury, loose stools, sinusitis, acne, dizziness, eating disorder, exanthema, influenza, oligomenorrhea, pneumonia. Decreased wt; Stevens-Johnson syndrome & other serious skin rashes w/ mucosal involvement.
Drug Interactions
Decreased conc w/ carbamazepine, phenobarb, phenytoin, vigabatrin or primidone. Increased conc w/ valproate. Decreased AUC of ethinyl estradiol & norethindrone. Reduced plasma conc of drugs metabolized by CPY3A4.
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
60's
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