Fycompa

Fycompa

perampanel

Manufacturer:

Eisai

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Perampanel
Indications/Uses
Adjunctive treatment of partial-onset seizures w/ or w/o secondarily generalized seizures in adult & adolescent from 12 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 Partial-onset seizures Initially 2 mg/day, may be increased by increments of 2 mg/day to a maintenance dose of 4-8 mg/day. Max recommended daily dose: 12 mg/day. Primary generalised tonic-clonic seizures Initially 2 mg/day, may be increased based on clinical response & tolerability by increments of 2 mg (either wkly or every 2 wk). Maintenance dose: Up to 8 mg/day. Max dose: 12 mg/day. Combination therapy w/ carbamazepine, oxcarbazepine, phenytoin Initially 4 mg/day, increased based on clinical response & tolerability by increments of 2 mg to a max of 12 mg/day at 1-wk interval. Mild hepatic impairment Initially 2 mg/day w/ increments of 2 mg every 2 wk until target dose is achieved. Max recommended daily dose: 6 mg. Moderate hepatic impairment Initially 2 mg/day w/ increments of 2 mg every 2 wk until target dose is achieved. Max recommended daily dose: 4 mg.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Monitor for signs of suicidal ideation & behavior; aggression & hostile behavior. Gradual discontinuation to minimize the potential for rebound seizures. Potentially, severe cutaneous adverse reactions including drug reaction w/ eosinophilia & systemic symptoms & Stevens-Johnson syndrome. Increased events related to dizziness, disturbance in gait & coordination & falls (particularly in the elderly). Monitor patients w/ history of substance abuse & monitor for symptoms of drug abuse. Concomitant use w/ OCs, CYP3A enzyme-inducing antiepileptics (carbamazepine, oxcarbazepine, phenytoin) & other concomitant (non-antiepileptic) CYP450 inducing or inhibiting drugs. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Not recommended in patients w/ moderate or severe renal impairment or patients undergoing hemodialysis & severe hepatic impairment. Hepatotoxicity (mainly increased hepatic enzyme) in combination w/ other antiepileptic drugs. Not recommended in women of childbearing potential not using contraception. May decrease effectiveness of progestative-containing hormonal contraceptives; additional non-hormonal form of contraception is recommended. Not recommended during pregnancy & lactation. Childn <12 yr. Elderly.
Adverse Reactions
Dizziness, somnolence, fatigue, irritability, falls, nausea, ataxia, balance disorder, gait disturbance, vertigo & wt gain.
Drug Interactions
Increased clearance w/ potent CYP3A enzyme inducers (eg, carbamazepine, phenytoin, oxcarbazepine). Decreased conc w/ other strong CYP450 inducers eg, rifampicin, hypericum (St. John's wort) & some antiretrovirals; phenobarb, primidone. Increased AUC & prolonged t½ w/ ketoconazole. Decreased AUC & exposure of midazolam & OCs (eg, ethinylestradiol & levonorgestrel). Avoid use w/ alcohol & other CNS depressants (eg, benzodiazepines, narcotics, barbiturates, sedating antihistamines).
MIMS Class
ATC Classification
N03AX22 - perampanel ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Fycompa FC tab 4 mg
Packing/Price
28's
Form
Fycompa FC tab 8 mg
Packing/Price
28's
Form
Fycompa FC tab 2 mg
Packing/Price
28's
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