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Fycompa

Fycompa

perampanel

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Perampanel
Indications/Uses
Adjunctive treatment of partial-onset seizures (POS) w/ or w/o secondarily generalized seizures in patients ≥4 yr & primary generalised tonic-clonic seizures (PGTCS) in patients ≥7 yr w/ idiopathic generalised epilepsy.
Dosage/Direction for Use
POS Adult, adolescent ≥12 yr & childn 4-11 yr, ≥30 kg 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 up to max: 12 mg daily, childn 4-11 yr, 20 to <30 kg Initially 1 mg daily, may be increased by 1-mg increments to maintenance dose: 4-6 mg daily. Then, may be further increased by 1-mg increments up to max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by 1-mg increments to maintenance dose: 2-4 mg daily. Then, may be further increased by 0.5-mg increments up to max: 6 mg daily. PGTCS Adult, adolescent ≥12 yr Initially 2 mg daily, may be increased by 2-mg increments to maintenance dose: 8 mg daily. Then, may be further increased by 2-mg increments up to max: to 12 mg daily, childn 7-11 yr, ≥30 kg 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 up to max: to 12 mg daily, 20 to <30 kg Initially 1 mg daily, may be increased by 1-mg increments to maintenance dose: 4-6 mg daily. Then, may be further increased by 1-mg increments up to max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by 1-mg increments to maintenance dose: 2-4 mg daily. Then, may be further increased by 0.5-mg increments up to max: 6 mg daily. Mild & moderate hepatic impairment Initially 2 mg daily, may be up-titrated by 2-mg increments no faster than every 2 wk. Max: Not to exceed 8 mg daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Severe cutaneous adverse reactions eg, DRESS, SJS. Monitor for signs of suicidal ideation & behaviours; patients with absence & myoclonic seizures. 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. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in moderate or severe renal impairment, patients undergoing hemodialysis & severe hepatic impairment. Hepatotoxicity. May affect ability to drive & use machines. Not recommended in women of childbearing potential & during pregnancy. Lactation. Childn <4 yr w/ POS or <7 yr w/ PGTCS. 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. 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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