INOVELON FILM-COATED TABLET 200 MG [SIN15146P]

Product Info

INOVELON FILM-COATED TABLET 200 MG

[SIN15146P]

4.1 Therapeutic Indications

Rufinamide is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years of age and older and in adults.

4.2 Posology and Method of Administration

Posology
Rufinamide film-coated tablets are for oral use. Rufinamide should be administered twice daily. If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.

Adjunctive Therapy in Patients with Seizures Associated with Lennox-Gastaut Syndrome (4 Years of Age and Older).

Use in children and adults less than 30 kg

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 up to a maximum recommended dose of 1000 mg/day. In clinical trials, the dose was increased as frequently as every two days. Doses of up to 3600 mg/day have been studied in a limited number of patients.

Treatment in patients also taking Valproate 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 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 up to a maximum recommended dose as indicated in the table below. In clinical trials, the dose was increased as frequently as every two days.

Doses of up to 4000 mg/day (in the 30–50 kg range) or 4800 mg/day (over 50 kg) have been studied in a limited number of patients.

Elderly Use

There is limited information on the use of rufinamide in the elderly. Since, the pharmacokinetics of rufinamide are not altered in the elderly (Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), 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. Hemodialysis may reduce exposure to a limited (about 30%) extent. Accordingly, adjusting the rufinamide dose during the dialysis process should be considered.

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.

Method of 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.

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.

4.3 Contraindications

Rufinamide is contraindicated in patients with known hypersensitivity to rufinamide, triazole derivatives, or to any excipients used in the formulation.