Rufinamide Dosage
Medically reviewed by Drugs.com. Last updated on Dec 2, 2024.
Applies to the following strengths: 200 mg; 400 mg; 40 mg/mL
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
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
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
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- This drug should be withdrawn gradually to minimize risk of precipitating seizure, seizure exacerbation, or status epilepticus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.
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