Fycompa

Fycompa

perampanel

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Perampanel
Indications/Uses
Adjunctive treatment of partial-onset seizures w/ or w/o secondarily generalized seizures in patients ≥12 yr w/ epilepsy & primary generalised tonic-clonic seizures in adult & adolescent patients from 12 yr w/ idiopathic generalised epilepsy.
Dosage/Direction for Use
Adult & adolescent Partial onset seizures Initially 2 mg daily, may be increased by 2-mg increments to maintenance dose: 4-8 mg daily. Then, may be further increased by 2-mg increments to 12 mg daily. Primary generalised tonic-clonic seizures Initially 2 mg daily, may be increased by 2-mg increments to maintenance dose: 8 mg daily. Then, may be further increased to 12 mg daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Severe cutaneous ARs eg, drug reaction w/ eosinophilia & systemic symptoms, Stevens-Johnson syndrome. Monitor for signs of suicidal ideation & behaviours. Increased risk of falls in elderly. Mood or behavioural pattern changes. History of substance abuse. Decreased effectiveness of progestative-containing hormonal contraceptives. Concomitant use w/ CYP3A-inducing anti-epileptic drugs & CYP450 inducers or inhibitors. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsoption. Not recommended in moderate or severe renal impairment, patients undergoing hemodialysis & severe hepatic impairment. Hepatotoxicity; mild & moderate hepatic impairment. May affect ability to drive & use machines. Not recommended in women of childbearing potential & during pregnancy. Lactation. Childn <12 yr. Elderly ≥65 yr.
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 Interactions
Decreased levonorgestrel exposure. Increased clearance by CYP450 3A enzyme inducers eg, carbamazepine, phenytoin, oxcarbazepine. Reduced levels by carbamazepine. Decreased oxcarbazepine clearance. Decreased midazolam AUC. Decreased conc by strong CYP450 inducers eg, rifampicin, Hypericum perforatum (St. John's wort); felbamate. Increased AUC & prolonged t½ by ketoconazole. Additive effects w/ alcohol.
MIMS Class
Anticonvulsants
ATC Classification
N03AX22 - perampanel ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Fycompa FC tab 2 mg
Packing/Price
28's
Form
Fycompa FC tab 4 mg
Packing/Price
28's
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