perampanel 8 mg
1 INDICATIONS AND USAGE FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 ) 1.1 Partial - Onset Seizures FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
eisai inc.
ROUND PURPLE E 295 8
E 295 8 ROUND PURPLE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied FYCOMPA Tablets 2 mg are orange, round, biconvex, film-coated tablets debossed with “2” on one side and “Є 275” on the other. They are supplied as follows: Bottles of 30 NDC 62856-272-30 Bottles of 90 NDC 62856-272-90 4 mg are red, round, biconvex, film-coated tablets debossed with “4” on one side and “Є 277” on the other. They are supplied as follows: Bottles of 30 NDC 62856-274-30 Bottles of 90 NDC 62856-274-90 6 mg are pink, round, biconvex, film-coated tablets debossed with “6” on one side and “Є 294” on the other. They are supplied as follows: Bottles of 30 NDC 62856-276-30 Bottles of 90 NDC 62856-276-90 8 mg are purple, round, biconvex, film-coated tablets debossed with “8” on one side and “Є 295” on the other. They are supplied as follows: Bottles of 30 NDC 62856-278-30 Bottles of 90 NDC 62856-278-90 10 mg are green, round, biconvex, film-coated tablets debossed with “10” on one side and “Є 296” on the other. They are supplied as follows: Bottles of 30 NDC 62856-280-30 Bottles of 90 NDC 62856-280-90 12 mg are blue, round, biconvex, film-coated tablets debossed with “12” on one side and “Є 297” on the other. They are supplied as follows: Bottles of 30 NDC 62856-282-30 Bottles of 90 NDC 62856-282-90 FYCOMPA Oral Suspension 0.5 mg/mL is a white to off-white opaque liquid. It is supplied in a round amber PET bottle with a child-resistant closure. It is packaged with a dispenser set that provides two 20-mL graduated oral dosing syringes and a push-in bottle adapter. Bottle containing 340 mL NDC 62856-290-38 16.2 Storage Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Oral Suspension: Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.
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