Fycompa

Fycompa

perampanel

Manufacturer:

Eisai

Distributor:

DKSH
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Perampanel
Indications/Uses
Adjunctive treatment of partial-onset seizures w/ or w/o secondarily generalised seizures in adult & adolescent ≥12 yr w/ epilepsy. Adjunctive treatment of primary generalised tonic-clonic seizures in adult & adolescent ≥12 yr w/ idiopathic generalised epilepsy.
Dosage/Direction for Use
Adult & adolescent Partial onset seizure Initially 2 mg/day, may be increased by increments of 2 mg (either wkly or every 2 wk) to a maintenance dose of 4-8 mg/day. Depending on clinical response & tolerability at dose of 8 mg/day, dose may be increased by increments of 2 mg/day to 12 mg/day. Primary generalised tonic-clonic seizures Initially 2 mg/day, may be increased by increments of 2 mg (either wkly or every 2 wk) to a maintenance dose of up to 8 mg/day. Depending on clinical response & tolerability at dose of 8 mg/day, dose may be increased up to 12 mg/day. Mild or moderate hepatic impairment Initially 2 mg, up-titrate using 2 mg doses no faster than every 2 wk. Max: 8 mg.
Administration
May be taken with or without food: Take at bedtime. Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Monitor for signs of suicidal ideation & behaviours. May decrease effectiveness of progestative-containing hormonal contraceptives. Increased risk of falls. Reports of aggressive & hostile behaviour. Abuse potential. Concomitant use w/ CYP3A inducing anti-epileptics & other concomitant (non-anti-epileptic) CYP450 inducers or inhibitors. Rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. May influence ability to drive or use machines. Not recommended in patients w/ moderate or severe renal impairment, patients undergoing haemodialysis, & patients w/ severe hepatic impairment. Not recommended in women of childbearing potential not using contraception. Pregnancy & lactation. Elderly. Childn <12 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 efficacy of progestative-containing OCs. Increased clearance & decreased plasma conc w/ some antiepileptics that are CYP450 3A enzyme inducers (eg, carbamazepine, phenytoin, oxcarbazepine). Decreased clearance of oxcarbazepine. Decreased AUC of midazolam. Decreased conc w/ strong CYP450 inducers (eg, rifampicin, hypericum). Increased AUC & prolonged t½ w/ ketoconazole (CYP3A4 inhibitor). Additive or supra-additive to the effects of alcohol.
MIMS Class
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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