|Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.Inovelon oral suspension and Inovelon film coated tablets may be interchanged at equal doses. Patients should be monitored during the switch over period. |
Use in children four years of age or older and less than 30 kg
Patients <30 kg not receiving valproate:Treatment should be initiated at a daily dose of 200 mg (5 ml dosing suspension given as two 2.5 ml doses, one in the morning and one in the evening). According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every two days, up to a maximum recommended dose of 1000 mg/day (25 ml/day). Doses of up to 3600 mg/day (90 ml/day) have been studied in a limited number of patients.
Patients <30 kg also receiving valproate:As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients <30 kg being co-administered valproate. Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day (15 ml/day).
Use in adults, adolescents and children four years of age or older of 30 kg or overTreatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses). According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every two days, up to a maximum recommended dose as indicated in the table below.
Doses of up to 4,000 mg/day (100 ml/day) in the 30-50 kg range or 4,800 mg/day (120 ml/day) in the over 50 kg category have been studied in a limited number of patients.
||30.0 50.0 kg
||50.1 70.0 kg
|Maximum recommended dose
||1,800 mg/day or
||2,400 mg/day or
||3,200 mg/day or
Discontinuation of treatmentWhen rufinamide treatment is to be discontinued, it should be withdrawn gradually. In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days.In the case of one or more missed doses, individualised clinical judgement is necessary.Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Paediatric populationThe safety and efficacy of rufinamide of children aged 4 years and less have not yet been established. No data are available.
ElderlyThere is limited information on the use of rufinamide in the elderly. Since, the pharmacokinetics of rufinamide are not altered in the elderly (see section 5.2), dosage adjustment is not required in patients over 65 years of age.
Renal impairmentA study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
Hepatic impairmentUse in patients with hepatic impairment has not been studied. Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment. Therefore, use in patients with severe hepatic impairment is not recommended.
Method of administrationRufinamide is for oral use. It should be taken twice daily with water in the morning and in the evening, in two equally divided doses. As a food effect was observed, it will preferable to should be administered with food (see section 5.2).
Film Coated TabletsIf the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Oral SuspensionThe oral suspension should be shaken vigorously before every administration. Please refer to section 6.6 for further details.