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Banzel

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Banzel

Banzel

INDICATIONS

BANZEL (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

DOSAGE AND ADMINISTRATION

BANZEL (rufinamide tablets) should be given with food. Tablets can be administered whole, as half tablets or crushed, for dosing flexibility.

BANZEL (rufinamide tablets) 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 The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle.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 (rufinamide tablets) Oral Suspension Dosing Instructions for complete instructions on how to properly dose and administer the BANZEL (rufinamide tablets) Oral Suspension.

Patient 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 ]

Patients Undergoing Hemodialysis

Hemodialysis may reduce exposure to a limited (about 30%) extent. Accordingly, adjusting the BANZEL (rufinamide tablets) dose during the dialysis process should be considered [see CLINICAL PHARMACOLOGY]

Patients with Hepatic Disease

Use of BANZEL (rufinamide tablets) 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 Population].

Patients on Antiepileptic Drugs (AEDs)

Patients on valproate should begin at a BANZEL (rufinamide tablets) dose lower than 10 mg/kg/day (children) or 400 mg/day (adults). For effects of other AEDs on BANZEL see DRUG INTERACTIONS.

HOW SUPPLIED

Dosage Forms And Strengths

Film coated Tablets: 200 mg (pink) and 400 mg (pink). Tablets are scored on both sides.

Oral Suspension: 40mg/mL.

Storage And Handling

BANZEL 200 mg tablets (containing 200 mg rufinamide) are pink in color, film-coated, oblong-shape tablets, with a score on both sides, imprinted with “ε 262” on one side. They are available in bottles of 30 (NDC 62856-582-30).

BANZEL 400 mg tablets (containing 400 mg rufinamide) are pink in color, film-coated, oblong-shape tablets, with a score on both sides, imprinted with “ε 263” on one side. They are available in bottles of 120 (NDC 62856-583-52).

BANZEL (rufinamide tablets) Oral Suspension is an orange flavored liquid supplied in a polyethylene terephthalate (PET) bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains a calibrated oral dosing syringe and an adapter. Store the oral suspension in an upright position. Use within 90 days of first opening the bottle, then discard any remainder. The oral suspension is available in bottles of 460 mL (NDC 62856-584-46).

Store the tablets at 25°C (77°F); excursions permitted to 15°- 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°- 30°C (59°F - 86°F). Replace cap securely after opening. The cap fits properly in place when the adapter is in place.

Manufactured by: Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677. Revised March 2011

Last reviewed on RxList: 4/22/2011
This monograph has been modified to include the generic and brand name in many instances.

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