Rufinamide Dosage

Medically reviewed by Drugs.com. Last updated on Nov 30, 2023.

Usual Adult Dose for Lennox-Gastaut Syndrome

Initial dose: 400 to 800 mg orally per day in 2 equally divided doses

• Titrate in 400 to 800 mg increments every other day until a maximum daily dose of 3200 mg/day is reached

Maintenance dose: 1600 mg orally twice a day

Comments:

• It is not known if doses lower than 3200 mg/day are effective.
• For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Usual Pediatric Dose for Lennox-Gastaut Syndrome

1 year of age or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses

• Titrate in 10 mg/kg increments every other day to a target dose of 45 mg/kg/day

Maintenance dose: 45 mg/kg orally per day in 2 equally divided doses
Maximum dose: 3200 mg/day

Comments:

• It is not known if doses lower than 45 mg/kg (not to exceed 3200 mg/day) are effective.
• For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment: Caution recommended
Severe hepatic impairment: Use not recommended

Dose Adjustments

Concomitant Administration of Valproate:

• For patients stabilized on rufinamide before initiating valproate: Initiate valproate at lower doses
• For patients stabilized on valproate before beginning rufinamide:
• Adults: Initial dose 400 mg orally per day
• Pediatrics: Initial dose 10 mg/kg/day

Withdrawal of antiepileptic drugs (AEDs):

• This drug should be withdrawn gradually to minimize risk of precipitating seizure, seizure exacerbation, or status epilepticus
• If abrupt discontinuation is medically necessary, the transition to another AED should be made under close medical supervision
• In clinical trials, discontinuation was achieved by reducing the dose by approximately 25% every 2 days.

Precautions

CONTRAINDICATIONS:

• In patients with Familial Short QT syndrome

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis may reduce plasma levels by about 30%; dose adjustments should be considered

Other Comments

Administration advice:

• Take orally with food
• May administer tablets whole, cut in half, or crushed
• Oral suspension: Shake well (vigorously) before every administration; measure dose using the enclosed bottle adapter and dosing syringe

Storage requirements:

• Oral tablets and suspension: Store at room temperature (59F to 86F [15C to 30C])
• Oral Suspension: Replace cap securely after opening; store in an upright position; use within 90 days of first opening the bottle

General:

• The oral suspension does not contain lactose or gluten and is dye-free.
• The oral tablets and oral suspension have been shown to be bioequivalent; patients should be monitored during the switch over period.

Monitoring:

• Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients/caregivers should understand that this drug may cause central nervous system adverse reactions such as somnolence, dizziness and coordination difficulties; patients should not drive or perform hazardous tasks until they have gained sufficient experience with this drug.
• Patients should understand that alcohol may cause additive central nervous system effects.
• Patients should be instructed to contact their healthcare provider if they experience a rash associated with a fever.
• Women of childbearing potential should be instructed on contraceptive use and instructed to notify their healthcare provider if they become pregnant or intend to become pregnant.

Frequently asked questions

• What is the mechanism of action of Banzel (rufinamide)?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer