Tablet
- Strengths
- 200, 400 mg
- Product note
- Scored; can be crushed.
Rufinamide
Banzel
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Banzel: adjunctive treatment of Lennox-Gastaut syndrome-associated seizures from age 1 year.
- Role
- Maintenance
- Class
- Sodium-channel modulation; slower recovery from inactivation in vitro
Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Banzel tablet/suspension U.S. label
Lennox-Gastaut syndrome · 1 year and older · Maintenance
Formulations & strengths
U.S. products unless another country is named. Strengths are per unit or stated volume.
Oral suspension
- Strengths
- 40 mg/mL (200 mg/5 mL)
- Product note
- Shake; give with food.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- Age ≥17: start 400–800 mg/day in 2 doses; increase 400–800 mg/day every other day to maximum 3,200 mg/day. With valproate start below 400 mg/day. Take with food.
- Pediatric
- Age 1–<17: start 10 mg/kg/day in 2 doses; increase 10 mg/kg/day every other day to 45 mg/kg/day, not exceeding 3,200 mg/day. With valproate start below 10 mg/kg/day.
- Titration / repeat dosing
- Children: 10 mg/kg/day in 2 doses; increase by 10 mg/kg every other day to 45 mg/kg/day (max 3,200 mg/day). Adults: 400–800 mg/day; increase by 400–800 mg every other day to 3,200 mg/day.
Practical administration
- Product instructions
- Give BANZEL with food. Tablets may be swallowed whole, halved or crushed. Shake oral suspension and use the supplied calibrated syringe.
Dose adjustment & concentrations
- Renal impairment
- No adjustment generally; dialysis may reduce exposure.
- Hepatic impairment
- Avoid severe; caution mild–moderate.
- Serum reference information
- No established therapeutic range
Safety
- Boxed warning
- No boxed warning.
- Contraindications
- Familial short-QT syndrome.
- Serious precautions & monitoring
- Shortens QT; take with food.
Common / selected adverse effects
- Somnolence
- Vomiting
- Headache
- Fatigue
- Dizziness
- Nausea
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Valproate | Increases rufinamide exposure, especially in children; dizziness, somnolence or vomiting may increase. | Start below 10 mg/kg/day in children or 400 mg/day in adults already taking valproate, per label. |
| Other QT-shortening drugs | Potential additive QT shortening. | Use caution; familial short QT syndrome is a contraindication. |
| Hormonal contraceptives / enzyme-inducing ASMs | Contraceptive effectiveness may fall; inducers can lower rufinamide exposure. | Use additional nonhormonal contraception; monitor response after ASM changes. |
Pregnancy & contraception
- Fetal / neonatal risk
- Human rufinamide pregnancy data are inadequate. Animal studies found developmental toxicity at clinically relevant doses.
- Contraception
- Rufinamide reduces exposure to ethinylestradiol/norethindrone and may impair hormonal contraception. Use an additional nonhormonal method.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Direct pivotal trial
Trial summary
- Study design / duration
- Multicenter, randomized, double-blind, placebo-controlled adjunctive trial in Lennox-Gastaut syndrome; 28-day baseline followed by 12-week treatment including titration.
- Primary endpoint
- No single pivotal endpoint is identified in the cited source.
- Results
- In the pivotal Lennox-Gastaut syndrome trial, total-seizure frequency decreased 33% with rufinamide versus 12% with placebo; tonic-atonic seizures decreased 43% versus a 2% increase with placebo.
Trial publications
Mechanism of action
- In vitro studies show prolonged sodium-channel inactivation and slower recovery after depolarization, reducing sustained repetitive action-potential firing.
- This is the principal proposed mechanism. The precise human antiseizure action is unknown; the label does not establish exclusive fast- or slow-inactivated-state selectivity.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- At least 85% absorbed based on urinary recovery; exposure becomes less than dose-proportional. Food increases exposure. Absolute oral-versus-IV bioavailability has not been established.
- Elimination half-life
- Approximately 6–10 hours.
- Volume of distribution
- Apparent volume approximately 50 L at 3,200 mg/day; depends on dose and body surface area.
- Active metabolite(s)
- None known: the principal carboxylic-acid metabolite is inactive.
- Active-metabolite half-life
- Not applicable — no clinically established active metabolite.
- Protein binding
- 34%
- Metabolism / elimination
- Carboxylesterase-mediated hydrolysis
Valproate increases rufinamide exposure, especially in smaller children.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- 2008
- Brands
- Banzel
- Manufacturer / marketer
- Eisai (Banzel)
- Generic availability
- Yes
- Related drugs
- Structurally distinct triazole derivative; not closely related to other marketed ASMs.
Sources & review status
Representative sources are selected product labels, not an exhaustive list of generic manufacturers. Consult the exact product and formulation prescribed. Brand-name package inserts are linked separately.
Brand reference: Banzel tablets / suspension ↗
Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 12/2022. This is a draft reference; final review is pending.