【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於有骨折風險之老年人(除非用於癲癇、調節情緒)。

(1) Partial-onset seizures: Treatment of partial-onset seizures with or without secondarily generalized seizures as adjunct or monotherapy in patients with epilepsy who are 4 years of age.
(2) Primary generalized tonic-clonic seizures: Treatment of primary generalized tonic-clonic seizures as adjunct therapy in patients with epilepsy who are 7 years of age.<20220503>
#仿單變更 2022

AMPA Glutamate Receptor Antagonist; Anticonvulsant
The exact mechanism by which perampanel exerts antiseizure activity is not definitively known; it is a noncompetitive antagonist of the ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on postsynaptic neurons. Glutamate is a primary excitatory neurotransmitter in the central nervous center causing many neurological disorders from neuronal over excitation.

Absorption:
1. Time to peak: 0.5 to 2.5 hours
2. Food slows rate of absorption(delayed ~1 to 3 hours with food)
Distribution:
Protein binding: ~95% to 96%; primarily albumin and alpha1-acid glycoprotein
Metabolism:
Extensive via primary oxidation mediated by CYP3A4/5, and to a lesser extent by CYP1A2 and CYP2B6, and sequential glucuronidation
Excretion:
Feces (48%); urine (22%)
Half-life elimination:
~105 hours

Specific contraindications have not been determined

Fetal risk cannot be ruled out.

Infant risk cannot be ruled out.

Common
Neurologic: Abnormal gait (1% to 16% ), Ataxia (1% to 8% ), Dizziness (16% to 43% ), Headache (11% to 13% ), Loss of equilibrium (3% to 5% ), Somnolence (9% to 18%)
Psychiatric: Irritability (4% to 12% ), Mood disorder (up to 2% )
Other: Fatigue (8% to 15% )
Serious
Dermatologic: Drug reaction with eosinophilia and systemic symptoms
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Psychiatric: Aggressive behavior (1% to 3% ), Homicidal thoughts, Suicidal thoughts

(For Children ≥12 years and Adolescents)
Not receiving enzyme-inducing antiepileptic drugs (AED):
1. Initial 2 mg orally once daily at bedtime; may increase by 2 mg/day no more frequently than once weekly based on clinical response and tolerability
2. Maintenance 8 to 12 mg orally once daily at bedtime (some may respond to 4 mg/day)
With concomitant enzyme-inducing AED:
1. Initial 4 mg orally once daily at bedtime; may increase by 2 mg/day no more frequently than once weekly
2. Maintenance dosage has not been established; highest dosage used in clinical trials was 12 mg orally once daily

1. CrCl ≥50 mL/minute: No dosage adjustment necessary.
2. CrCl 30 to 49 mL/minute: No dosage adjustment necessary; monitor closely and consider slower titration based on response and tolerability.
3. CrCl <30 mL/minute, Hemodialysis: Use not recommended (has not been studied).

1. Mild impairment (Child-Pugh class A):
Initial 2 mg once daily; may increase daily dose by 2 mg once daily no more frequently than every 2 weeks based on response and tolerability. Maximum: 6 mg once daily
2. Moderate impairment (Child-Pugh class B):
Initial 2 mg once daily; may increase daily dose by 2 mg once daily no more frequently than every 2 weeks based on response and tolerability. Maximum: 4 mg once daily
3. Severe impairment (Child-Pugh class C):
Use not recommended (has not been studied)