August 1, 2015
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Banzel

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Banzel




Indications
Dosage
How Supplied

INDICATIONS

BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.

DOSAGE AND ADMINISTRATION

Dosage Information

Pediatric Patients (1 Year to less than 17 Years)

The recommended starting daily dose of BANZEL in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than the target doses are effective.

Adults (17 Years and Older)

The recommended starting daily dose of BANZEL in adults with Lennox-Gastaut Syndrome is 400 to 800 mg per 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, administered in two equally divided doses, is reached. It is not known whether doses lower than 3200 mg are effective.

Administration Information

Administer BANZEL with food. BANZEL film-coated tablets can be administered whole, as half tablets or crushed.

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 The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle.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 PATIENT INFORMATION].

Dosing In 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].

Dosing In 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].

Dosing In Patients Taking Valproate

Patients taking valproate should begin BANZEL at a dose lower than 10 mg/kg per day in pediatric patients or 400 mg per day in adults [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: 40 mg/mL.

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 “ 262” on one side. They are available in bottles of 120 (NDC 62856-582-52).

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 “ 263” on one side. They are available in bottles of 120 (NDC 62856-583-52).

BANZEL 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).

Storage And Handling

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.

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised June 2015

Last reviewed on RxList: 7/13/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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