儿童和成人使用卢非酰胺的剂量一样吗？

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

The dosage of rufinamide for children and adults is different, and the dosage form is also different. Rufinamide is available in two dosage forms: film-coated tablets and oral suspension. Most adults take film-coated tablets, while children take oral suspension or film-coated tablets.

The European Commission and the US FDA approved rufinamide in 2007 and 2008 respectively for the adjuvant treatment of epilepsy associated with Lennox-Gastaut syndrome in children over 4 years old and in adults.

Rufinamide treats diseases

The exact mechanism of its anti-epileptic effect is still unclear. In vitro study results indicate that the main mechanism of action of rufinamide is to regulate the activity of sodium channels, especially prolonging the inactive state of the channels.

In cultured cortical nerves, rufinamide significantly slows down the recovery of sodium channels from the inactivated state after a prolonged prepulse and limits the sustained and repetitive firing of sodium-dependent action potentials. It is suitable for the adjuvant treatment of epileptic seizures related to Lennox-Gastaut syndrome in children 1 year old and above and in adults.

How to use rufinamide

Rufinamide needs to be taken with food. Rufinamide film-coated tablets can be taken as a whole tablet, half a tablet or crushed.

Rufinamide oral suspension should be shaken well before each dose, and oral suspension should be administered using the adapter and calibrated oral dosing syringe provided.

The adapter provided in the product carton should be securely inserted into the neck of the bottle before use and remain in place during use of the bottle. The dosing syringe should be inserted into the adapter and the dose removed from the inverted bottle. The cap should be replaced after each use.

of rufinamide

1. Children (under 1-17 years old): The recommended starting daily dose of rufinamide for pediatric patients with Lennox-Gastaut syndrome is approximately 10 mg/kg, administered in two equal doses. The dose should be increased by approximately 10 mg/kg every other day until the maximum daily dose of 45 mg/kg is reached, not to exceed 3200 mg in two equally divided doses. It is unclear whether doses lower than the target dose are effective.

2. Adults (17 years and above): The recommended starting daily dose is 400-800 mg per day, administered in two equal portions. The dose should be increased by 400-800 mg every other day until the maximum daily dose is reached 3200 mg, administered in two equal portions.

Medication for special populations

1. Patients receiving hemodialysis: Hemodialysis can reduce the exposure of rufinamide to a limited extent, about 30%, and the dose of rufinamide should be considered to be adjusted during the dialysis process.

2. Patients with liver disease: There have been no studies on the use of rufinamide in patients with liver damage. Therefore, it is not recommended for patients with severe hepatic impairment and should be used with caution in patients with mild to moderate hepatic impairment.

3. Patients taking sodium valproate: When patients taking sodium valproate start taking rufinamide, the dose for pediatric patients should be less than 10 mg/kg per day, and for adult patients, the dose should be less than 400 mg per day.

Rufinamide for the treatment of epilepsy

In a well-designed 16-week trial, adjunctive oral rufinamide was more effective than placebo in the treatment of seizures associated with refractory Lennox-Gastaut syndrome in children, adolescents, and adults. The rufinamide group had a significant reduction from baseline in total seizure frequency and median tonic-flaccid seizure frequency per 28 days and showed an improvement in seizure severity compared with the placebo group.

Furthermore, these beneficial effects of rufinamide on seizure frequency were maintained during a subsequent 3-year open-label extension study. Adjuvant rufinamide treatment significantly reduced the frequency of partial seizures per 28 days compared with placebo in two well-designed trials lasting approximately 3 months.

A higher proportion of patients treated with rufinamide had a ≥50% reduction in partial seizure frequency every 28 days. In patients with Lennox-Gastaut syndrome and partial seizures, rufinamide was generally well tolerated and adverse events were mostly mild or moderate.