Fycompa

Fycompa

perampanel

Manufacturer:

Eisai

Distributor:

Zuellig
/
HI-Eisai
Concise Prescribing Info
Contents
Perampanel
Indications/Uses
Treatment of partial-onset seizures w/ or w/o secondarily generalized seizures in adult & paed patients from 4 yr w/ epilepsy. Adjunctive treatment of primary generalized tonic-clonic seizures in adult & adolescent from 12 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Adult & paed Once daily at bedtime. Partial onset seizures Initially 2 mg/day, may be increased by increments of 2 mg/day wkly or every 2 wk up to maintenance of 4-8 mg/day. May further increased by increments of 2-12 mg/day if tolerated. Primary generalized tonic-clonic seizures Initially 2 mg/day, may be increased by increments of 2 mg/day wkly or every 2 wk to a maintenance of up to 8 mg/day. May further increase to 12 mg/day if tolerated. Patient w/ mild & moderate hepatic impairment Initiate at 2 mg. Patient should be up-titrated using 2 mg doses no faster than every 2 wk based on tolerability & effectiveness. Max: 8 mg.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Aggression & hostile behavior; suicidal ideation & behavior. Concomitant use w/ progestative-containing hormonal contraceptives, CYP3A inducing anti-epileptics eg, carbamazepine, phenytoin, oxcarbazepine & other non-anti-epileptics (CYP450 inducer/inhibitors). Avoid abrupt discontinuation. Monitor patients w/ history of substance abuse. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Moderate or severe renal & hepatic impairment & hemodialysis. May influence ability to drive or use machines. Women of childbearing potential not using contraception. Pregnancy & lactation. Childn <12 yr. Elderly.
Adverse Reactions
Dizziness, somnolence. Decreased/increased appetite; aggression, anger, anxiety, confusional state; ataxia, dysarthria, balance disorder, irritability; diplopia, blurred vision; vertigo; nausea; back pain; gait disturbance, fatigue; increased wt; fall; drug reaction w/ eosinophilia & systemic symptoms (DRESS)/multiorgan hypersensitivity.
Drug Interactions
May decrease efficacy of progestative-containing OCs. Decreased plasma conc w/ carbamazepine, phenytoin, oxcarbazepine, topiramate. May decrease exposure of midazolam. Decreased conc w/ strong inducers of CYP450 (eg, rifampicin & hypericum) & felbamate. Increased AUC & prolonged t½ w/ ketoconazole. Additive or supra-additive effects w/ alcohol (on tasks involving alertness & vigilance eg, driving ability).
MIMS Class
Anticonvulsants
ATC Classification
N03AX22 - perampanel ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Fycompa FC tab 2 mg
Packing/Price
7's
Form
Fycompa FC tab 4 mg
Packing/Price
28's
Form
Fycompa FC tab 8 mg
Packing/Price
28's
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