FYCOMPA ORAL SUSPENSION CIII
Generic Name and Formulations:
Indications for FYCOMPA ORAL SUSPENSION:
Monotherapy or adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥12yrs of age. Adjunctive treatment of primary generalized tonic-clonic seizures in patients ≥12 yrs.
Partial-onset: 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: 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. May antagonize midazolam. Potentiates oxcarbazepine. Potentiated by ketoconazole. Caution with concomitant CNS depressants (eg, benzodiazepines, narcotics, barbiturates, sedating antihistamines) and alcohol. Reduces effectiveness of levonorgestrel (oral or implant 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)
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