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| BANZEL®(rufinamide) Tablet, Film Coated for Oral Use
BANZEL®(rufinamide) Oral Suspension
Initial U.S. Approval: 2008
BANZEL is available for oral administration in film-coated tablets, scored on both sides, containing 200 and 400 mg of rufinamide. Inactive ingredients are colloidal silicon dioxide, corn starch, crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. The film coating contains hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.
BANZEL is also available for oral administration as a liquid containing rufinamide at a concentration of 40 mg/mL. Inactive ingredients include microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethylcellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, noncrystallizing sorbitol solution 70%, and an orange flavor.
| CLINICAL PHARMACOLOGY
Mechanism of Action
The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown.
The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel. Rufinamide (>/=1 µM) significantly slowed sodium channel recovery from inactivation after a prolonged prepulse in cultured cortical neurons, and limited sustained repetitive firing of sodium-dependent action potentials (EC50 of 3.8 µM).
| INDICATIONS AND USAGE
BANZEL (rufinamide) is an anti-epileptic drug indicated for:
Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
USE IN SPECIFIC POPULATIONS
Renal impairment: Renally impaired patients (creatinine clearance less than 30 mL/min) do not require any specific dosage change. Adjusting the BANZEL dose for the loss of drug upon dialysis should be considered.
Hepatic impairment: Use in patients with severe hepatic impairment is not recommended. Caution should be exercised in treating patients with mild to moderate hepatic impairment.
| WARNINGS AND PRECAUTIONS
| ADVERSE REACTIONS
In all patients with epilepsy treated with BANZEL in double-blind, adjunctive therapy studies, the most commonly observed adverse reactions (>/=10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea
To report SUSPECTED ADVERSE REACTIONS, contact Eisai, Inc. at 1-888-274-2378 or www.banzel.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION SUMMARY
BANZEL should be given with food. Tablets can be administered whole, as half tablets, or crushed.
The prescribed amount of the oral suspension should be measured using the provided adapter and dosing syringe
Children four years and older with LGS: 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.
Adults with LGS: 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 dose of 3200 mg/day, administered in two equally divided doses is reached.
DOSAGE AND ADMINISTRATION
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.
Patient with Lennox-Gastaut Syndrome
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
Patients Undergoing Hemodialysis
Patients with Hepatic Disease
Patients on Antiepileptic Drugs (AEDs)
| DOSAGE FORMS AND STRENGTHS
-200 mg (pink), 400 mg (pink), film-coated tablets with a score on both sides.
-40 mg/mL oral suspension.
Store the tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Protect from moisture. Replace cap securely after opening.
Store the oral suspension at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Replace cap securely after opening. The cap fits properly in place when the adapter is in place.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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