Rx Item-Banzel 400mg Tab 120 by Eisai

BANZEL- rufinamide tablet, film coated
BANZEL- rufinamide suspension
Eisai Inc.

1 I NDICATIONS AND USAGE

? 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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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 The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle.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 Counseling Information ( 17)].

2. 3 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 [s ee Clinical Pharmacology ( 12.3) ].

2. 4 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 Population s ( 8.7) ].

2. 5 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 Int eractions ( 7.2) ] .

3 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 400mg Tab 120 by Eisai
NDC No. 62856-0583-52 UPC/GTIN No. 3-62856-58352-7 MPN 58352 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

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Eisai Inc.

RUFINAMIDE ORAL TABLET 40
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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