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(perampanel) Tablets, for Oral Use
SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
- Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA
- These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression
- Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA
- Closely monitor patients particularly during the titration period and at higher doses
- FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening
FYCOMPA tablets contain perampanel, a non-competitive AMPA receptor antagonist. Perampanel is described chemically as 2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3).
The molecular formula is C23H15N3O •3/4H2O and the molecular weight is 362.90 (3/4 hydrate). The chemical structure of perampanel is:
Perampanel is a white to yellowish white powder. It is freely soluble in N-methylpyrrolidone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether and practically insoluble in heptane and water.
FYCOMPA (perampanel) tablets are round, bi-convex, film coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc and titanium dioxide. Tablets of different strengths also may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg) and FD&C blue # 2 indigo carmine aluminum lake (10 mg and 12 mg).
Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Fycompa Information
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