Generic name: rufinamide
Dosage form: tablet, film coated; oral suspension
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BANZEL should be given with food. Tablets can be administered whole, as half tablets or crushed, for dosing flexibility.
BANZEL Oral Suspension should be shaken well before every administration. The provided adapter and calibrated oral dosing syringe should be used to administer the oral suspension. The adapter which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle. The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle. The cap should be replaced after each use. The cap fits properly when the adapter is in place. See BANZEL Oral Suspension Dosing Instructions for complete instructions on how to properly dose and administer the BANZEL Oral Suspension.
Patients with Lennox-Gastaut Syndrome
Children four years and older with Lennox-Gastaut Syndrome: Treatment should be initiated at a daily dose of approximately 10 mg/kg/day administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in two equally divided doses. It is not known whether doses lower than the target doses are effective.
Adults with Lennox-Gastaut Syndrome: Treatment should be initiated at a daily dose of 400-800 mg/day administered in two equally divided doses. The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg/day, administered in two equally divided doses is reached. It is not known whether doses lower than 3200 mg are effective.
Patients with Renal Impairment
Renally impaired patients (creatinine clearance less than 30 mL/min) do not require any special dosage change when taking BANZEL [see Clinical Pharmacology (12.3)].
Patients Undergoing Hemodialysis
Hemodialysis may reduce exposure to a limited (about 30%) extent. Accordingly, adjusting the BANZEL dose during the dialysis process should be considered [see Clinical Pharmacology (12.3)].
Patients with Hepatic Disease
Use of BANZEL in patients with hepatic impairment has not been studied. Therefore, use in patients with severe hepatic impairment is not recommended. Caution should be exercised in treating patients with mild to moderate hepatic impairment [see Use in Specific Populations, (8.7)].
Patients on Antiepileptic Drugs (AEDs)
Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg/day (children) or 400 mg/day (adults). For effects of other AEDs on BANZEL see Drug Interactions (7.2).