Indications for FYCOMPA ORAL SUSPENSION:
Monotherapy or adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥4yrs of age. Adjunctive treatment of primary generalized tonic-clonic seizures in patients ≥12yrs.
Adults and Children:
Partial-onset: <4yrs: not established. ≥4yrs: initially 2mg/day at bedtime; may increase by 2mg/day no more than once per week to 4–12mg/day; max 12mg/day. Tonic-clonic: <12yrs: not established. ≥12yrs: initially 2mg/day at bedtime; may increase by 2mg/day no more than once per week to 8–12mg/day. Concomitant moderate or strong CYP3A4 inducers: initially 4mg/day at bedtime. Elderly or hepatic impairment: max frequency for dose increase is every 2 weeks; mild: max 6mg/day; moderate: max 4mg/day. Severe hepatic or renal impairment, hemodialysis: not recommended.
Serious psychiatric and behavioral reactions.
Increased risk of serious psychiatric and behavioral reactions (eg, aggression, hostility, irritability); monitor during treatment (esp. initial titration period or at higher doses) and one month after last dose; reduce dose or permanently discontinue if symptoms persist. Increased risk of suicidal thoughts or behavior; monitor for clinical worsening or unusual changes. Increased risk of neurologic effects (eg, dizziness, gait disturbance, somnolence, fatigue) or falls and injuries; monitor (esp. elderly). Avoid abrupt cessation. Elderly: titrate slowly. Pregnancy. Nursing mothers.
AMPA glutamate receptor antagonist.
Antagonized by moderate and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, oxcarbazepine, topiramate, rifampin, St. John’s wort); see Adult. Caution with concomitant CNS depressants (eg, benzodiazepines, narcotics, barbiturates, sedating antihistamines). Avoid alcohol. Reduces effectiveness of levonorgestrel-containing contraceptives; use additional non-hormonal form during and for 1 month after discontinuation.
Dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, anxiety, gait disturbance, balance disorder; psychiatric reactions, DRESS/multiorgan hypersensitivity (discontinue if occurs).
Tabs—30, 90; Susp—340mL (w. dosing syringes and adapter)