Classes
DEA Class; Rx
Common Brand Names; Banzel
- Anticonvulsants,Others
Description
Triazole derivative anticonvulsant
Used for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
Approved for use in patients >= 1 year
Indications
Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.
Contraindications
Documented hypersensitivity
Familial Short QT syndrome
Adverse Effects
Diplopia
Dizziness
Fatigue
Headache
Somnolence
Nausea
Vomiting
Steven’s-Johnson syndrome
Warnings
Shortens QT interval
Not recommended in severe hepatic impairment
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported in patients taking antiepileptic drugs, including rufinamide; DRESS may be fatal or life-threatening; if DRESS suspected, evaluate patient immediately; discontinue therapy and initiate alternative treatment
Withdraw gradually
May impair ability to drive or perform hazardous tasks
May render hormonal contraceptives ineffective
Pregnancy and Lactation
Data are unavailable on the developmental risk associated with use in pregnant women
Data are not available regarding rufinamide presence in human milk, effects on breastfed infants, or effects on milk production
Maximum Dosage
3200 mg/day PO.
3200 mg/day PO.
17 years: 3200 mg/day PO.
13—16 years: 45 mg/kg/day PO (Max: 3200 mg/day).
45 mg/kg/day PO (Max: 3200 mg/day).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Rufinamide
tablet
- 200mg
- 400mg
oral suspension
- 40mg/mL