Banzel 400 mg/1
rufinamide · TABLET, FILM COATED · Eisai Inc.
Banzel is a tablet, film coated containing rufinamide at 400 mg/1, taken oral. Manufactured by Eisai Inc..
Key Facts
- Brand Name
- Banzel
- Generic Name
- rufinamide
- NDC Code (Product)
62856-583- Manufacturer
- Eisai Inc.
- Strength
- 400 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021911
- Marketing Start
- 11/14/2008
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION BANZEL should be given with food. Tablets can be administered whole, as half tablets, or crushed ( 2.2 ) Measure oral suspension using provided adapter and dosing syringe ( 2.2 ) Pediatric patients 1 year and older: Starting daily dose: 10 mg/kg per day in two equally divided doses ( 2.1 ) Increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg per day, not to exceed 3200 mg per day, in two divided doses ( 2.1 ) Adults: Starting daily dose: 400-800 mg per day in two equally divided doses ( 2.1 ) Increase by 400-800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached ( 2.1 ) 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 …
Contraindications
4 CONTRAINDICATIONS BANZEL is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ( 5.3 ) ] . BANZEL is contraindicated in patients with Familial Short QT syndrome ( 4 )
Drug Interactions
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Any effects, when they occur, have been more marked in the pediatric population. Table 6 summarizes the drug-drug interactions of BANZEL with other AEDs. Table 6: Summary of drug-drug interactions of BANZEL with other antiepileptic drugs AED Co-administered Influence of Rufinamide on AED concentration a) Influence of AED on Rufinamide concentration Carbamazepine Decrease by 7 to 13% b) Decrease by 19 to 26% Dependent on dose of carbamazepine Lamotrigine Decrease by 7 to 13% b) No Effect Phenobarbital Increase by 8 to 13% b) Decrease by 25 to 46% c) ’ d) Independent of dose or concentration of phenobarbital Phenytoin In…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Central Nervous System Reactions [see Warnings and Precautions ( 5.2 )] QT Shortening [see Warnings and Precautions ( 5.3 )] Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4 )] Leukopenia [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥ 10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients ages 3 to 17 years of age In the pooled, double-blind, adjunctive therapy studies in adult and p…
Frequently Asked Questions
What is Banzel used for?
Banzel contains rufinamide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Banzel a controlled substance?
Banzel is not classified as a controlled substance by the DEA.
What is the generic name for Banzel?
The generic name for Banzel is rufinamide. There are 11 other brand versions of rufinamide.
What is the NDC code for Banzel 400 mg/1?
The NDC (National Drug Code) for Banzel 400 mg/1 is 62856-583, listed by Eisai Inc..