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Banzel Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Rufinamide 40mg/mL; orange-flavor; lactose-, gluten-, and dye-free.
Pharmacological Class
Antiepileptic.
See Also
How Supplied
Tabs—120; Susp—460mL (w. adapter & dosing syringe)
Manufacturer
Banzel Oral Suspension Indications
Indications
Adjunctive treatment of seizures in Lennox-Gastaut syndrome.
Banzel Oral Suspension Dosage and Administration
Adult
Take with food in 2 equally divided doses. ≥17yrs: initially 400–800mg per day; increase by 400–800mg/day every other day up to max 3200mg/day. Avoid abrupt cessation (reduce dose by 25% every 2 days).
Children
<1yrs: not established. Take with food in 2 equally divided doses. 1–<17yrs: initially 10mg/kg per day; increase every other day by 10mg/kg up to max 45mg/kg per day or 3200mg/day (whichever is less). Avoid abrupt cessation (reduce dose by 25% every 2 days).
Banzel Oral Suspension Contraindications
Contraindications
Familial short QT syndrome.
Banzel Oral Suspension Boxed Warnings
Not Applicable
Banzel Oral Suspension Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thoughts or behavior; monitor for new or worsening of depression, suicidal thoughts, or unusual changes. Severe hepatic impairment: not recommended. Mild to moderate hepatic impairment. Dialysis (may adjust dose). Monitor for multi-organ hypersensitivity reactions; discontinue if suspected. Pregnancy. Nursing mothers.
Banzel Oral Suspension Pharmacokinetics
See Literature
Banzel Oral Suspension Interactions
Interactions
Caution with drugs that shorten QT interval. CNS depression with alcohol, other CNS depressants. Antagonizes carbamazepine, lamotrigine, triazolam. May potentiate phenobarbital, phenytoin. Potentiated by valproate (reduce doses). Antagonized by carbamazepine, phenobarbital, primidone, phenytoin. May affect substrates of CYP3A4, CYP2E1 (monitor). Antagonizes hormonal contraceptives (use additional non-hormonal forms). May be affected by inducers or inhibitors of carboxylesterases.
Banzel Oral Suspension Adverse Reactions
Adverse Reactions
Headache, dizziness, fatigue, somnolence, nausea, incoordination, gait disturbances, ataxia, visual disturbances, leukopenia, fever/rash.
Banzel Oral Suspension Clinical Trials
See Literature
Banzel Oral Suspension Note
Not Applicable
Banzel Oral Suspension Patient Counseling
See Literature
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