Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
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. 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. Doses of up to 3600 mg/day have been studied in a limited number of patients.
Patients <30 kg Also Receiving Valproate Medication: 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.
Use in Adults, Adolescents and Children Four Years of Age or Older of 30 kg or Over: Treatment should be initiated at a daily dose of 400 mg. 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 Table 1 (see Table 1).
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Doses of up to 4,000 mg/day (in the 30-50 kg range) or 4,800 mg/day (in the over 50 kg) have been studied in a limited number of patients.
Discontinuation of Rufinamide: When rufinamide treatment is to be discontinued, it should be withdrawn gradually.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 judgment is necessary.
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Paediatric Population: The safety and efficacy of rufinamide of children aged 4 years and less have not yet been established. No data are available.
Older People: There is limited information on the use of rufinamide in older people. Since, the pharmacokinetics of rufinamide are not altered in older people (see Pharmacology: Pharmacokinetics under Actions), dosage adjustment is not required in patients over 65 years of age.
Renal Impairment: A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: Use 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. Use in patients with severe hepatic impairment is not recommended.
Administration: Rufinamide 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, rufinamide should be administered with food (see Pharmacology: Pharmacokinetics under Actions). If the patient has difficulty swallowing, tablets can be crushed and administered in half a glass of water.