Adult Dosing
Seizures associated with Lennox-Gastaut syndrome
- Initial dose: 400-800 mg/day PO in two equally divided doses
- Increase the dose by 400–800 mg every other day until a dose of 1600 mg PO bid is reached
- Max dose: 3200 mg/day
Note:
- The drug should be taken with food
Pediatric Dosing
Seizures associated with Lennox-Gastaut syndrome
Children 
4 yrs
- Initial dose: 10 mg/kg/day PO in two equally divided doses
- Increase the dose by 10 mg/kg every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, in two equally divided doses
- Max: 3200 mg/day
Note:
- The drug should be taken with food
See Supplemental Patient Information
- Rufinamide therapy has been associated with an increased risk of suicidal thoughts or behavior, which was observed as early as one week after initiating therapy and persisted for the duration of treatment assessed; monitor patients closely for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior
- Inform patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm
- Physicians prescribing rufinamide must balance the risk of suicidal thoughts or behavior with the risk of untreated illness
- CNS adverse reactions such as somnolence or fatigue, coordination abnormalities, dizziness, and ataxia have been reported in some patients receiving therapy
- Multi-organ hypersensitivity syndrome, a serious condition sometimes induced by antiepileptic drugs, may occur with rufinamide
- To minimize the risk of precipitating seizures, seizure exacerbations, or status epilepticus, withdraw the drug gradually by reducing the dose by 25 % every 2 days. Transition to alternate therapy under close medical supervision should be made, if abrupt discontinuation is indicated
- Treatment-emergent status epilepticus has been reported in controlled-clinical trials
- Treatment with rufinamide has been associated with shortening of the QT interval
Cautions: Use cautiously in
- History of suicidal thoughts or behavior
- History of depression
- Drugs that shorten the QT interval
Supplemental Patient Information
- Inform patients, their caregivers and families of the need to be alert for the emergence or worsening of depression, any unusual changes in behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm; advise them to report these behaviors of concern promptly to their health care providers
- Advise patients to avoid alcohol during rufinamide therapy as it may cause additive central nervous system effects
- Instruct patients to notify their physicians if they experience a rash associated with fever
- Advise patients regarding the potential for somnolence or dizziness and inform them not to operate machinery or drive until they have gained sufficient experience on the drug to gauge how it affects their performance ability
- Caution women of childbearing potential that the concomitant use of rufinamide with hormonal contraceptives may render this form of contraception less effective; consider non-hormonal methods of contraception during therapy
- Advise patients prescribed with oral suspension to shake the bottle vigorously before every administration and to use the adapter and oral dosing syringe
Pregnancy Category:C
Breastfeeding: Safety unknown. According to the manufacturer's data, rufinamide is likely to be excreted in breast milk. Because of the potential for serious adverse events in nursing infants, a decision should be made regarding discontinuation of nursing or discontinuation of the drug, analyzing the importance of the drug to the mother.
Drug Name: Banzel 200 MG Oral Tablet
Ingredient(s): Rufinamide
Imprint: 262
Color(s): Pink
Shape: Oval
Size (mm): 15.00
Score: 2
Inactive Ingredient(s): colloidal silicon dioxide / corn starch / crosscarmellose sodium / hypromellose / lactose monohydrate / magnesium stearate / microcrystalline cellulose / sodium lauryl sulphate / iron oxide red / polyethylene glycol / talc / titanium dioxide
Drug Label Author:
Eisai Inc.
DEA Schedule:
Non-Scheduled
Drug Name: Banzel 400 MG Oral Tablet
Ingredient(s): Rufinamide
Imprint: 263
Color(s): Pink
Shape: Oval
Size (mm): 18.00
Score: 2
Inactive Ingredient(s): colloidal silicon dioxide / corn starch / crosscarmellose sodium / hypromellose / lactose monohydrate / magnesium stearate / microcrystalline cellulose / sodium lauryl sulphate / iron oxide red / polyethylene glycol / talc / titanium dioxide
Drug Label Author:
Eisai Inc.
DEA Schedule:
Non-Scheduled
