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Pharmacologic classification: triazole derivative
Therapeutic classification: antiepileptic
Pregnancy risk category: C
AVAILABLE FORMS
Tablets: 200 mg, 400 mg
INDICATIONS AND DOSAGES
Adjunct treatment of seizures associated with Lennox–Gastaut syndrome—
Adults: Initially, 200 to 400 mg P.O. b.i.d. Increase dosage by 400 to 800 mg/day every 2 days to 3,200 mg daily in divided doses.
Children age 4 and older: Initially, 5 mg/kg b.i.d. Increase dosage by 10 mg/kg every other day to 45 mg/kg or 3,200 mg (whichever is less) daily in divided doses.
ADJUST-A-DOSE: Dialysis clears the drug by 30%; dosage adjustment may be necessary.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with familial short QT syndrome and in those with severe hepatic impairment.
Use cautiously in patients with mild to moderate hepatic impairment.
INTERACTIONS
Drug-drug.
Phenytoin, phenobarbital: May increase levels of these drugs and decrease rufinamide's effect. Use together cautiously.
Carbamazepine: May decrease effectiveness of both drugs. Use together cautiously.
Ethinyl estradiol and norethindrone: May decrease effectiveness of the drugs. Use a nonhormonal form of contraception.
Lamotrigine: May decrease drug levels. Monitor patient closely.
Primidone: May decrease rufinamide levels. Use together cautiously.
Valproate: May increase rufinamide levels. Titrate valproate dose slowly.
Triazolam: May decrease drug levels. Use together cautiously.
Drug-lifestyle.
Alcohol: May cause additive CNS effect. Discourage use together.
ADVERSE REACTIONS
CNS: aggression, anxiety, ataxia, attention disturbance, dizziness, fatigue, gait disturbance, headache, psychomotor hyperactivity, seizure, somnolence, tremor, vertigo.
EENT: blurred vision, diplopia, ear infection, nasopharyngitis, nystagmus, sinusitis.
GI: constipation, decreased appetite, dyspepsia, increased appetite, nausea, upper abdominal pain, vomiting.
Hematologic: leukopenia.
Musculoskeletal: back pain.
Respiratory: bronchitis.
Skin: pruritis, rash.
Other: influenza.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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