Rufinamide is a prescription medicine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. It is available as tablets and oral suspension. MedsAcross supplies Rufinamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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
Source: US FDA prescribing information
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 (EC 50 of 3.8 μM).
Source: US FDA prescribing information
BANZEL should be given with food. Tablets can be administered whole, as half tablets, or crushed. Measure oral suspension using provided adapter and dosing syringe. Pediatric patients 1 year and older: Starting daily dose: 10 mg/kg per day in two equally divided doses. 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. Adults: Starting daily dose: 400-800 mg per day in two equally divided doses. Increase by 400-800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached
Source: US FDA prescribing information
BANZEL is contraindicated in patients with Familial Short QT syndrome.
Source: US FDA prescribing information
Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior. Central nervous system reactions can occur. Use caution when administering BANZEL with other drugs that shorten the QT interval. Discontinue BANZEL if multi-organ hypersensitivity reaction occurs. Withdraw BANZEL gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus
Source: US FDA prescribing information
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation Central Nervous System Reactions QT Shortening Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Leukopenia Most common adverse reactions (≥ 10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea
Source: US FDA prescribing information
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). Hormonal contraceptives may be less effective with BANZEL, use additional non-hormonal forms of contraception
Source: US FDA prescribing information
Store the tablets at 25ºC (77ºF), excursions permitted to 15º- 30ºC (59ºF - 86ºF). Store the oral suspension at 25ºC (77ºF), excursions permitted to 15º- 30ºC (59ºF - 86ºF). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Rufinamide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Rufinamide 40 mg/mL oral suspensionOralGeneric name | — | US FDA | Available on request |
| Rufinamide 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Rufinamide 400 mg tabletOralGeneric name | — | US FDA | Available on request |
| Banzel 200 mg tabletOral | Eisai | US FDA | Available on request |
| Banzel 40 mg/mL oral suspensionOral | Eisai | US FDA | Available on request |
| Banzel 400 mg tabletOral | Eisai | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 6 presentations of Rufinamide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Rufinamide, including Banzel.
Yes. The US FDA first approved Rufinamide on 14 November 2008, according to Drugs@FDA.
Yes. Rufinamide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Rufinamide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Rufinamide is classified under ATC code N03AF03 (Rufinamide).
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