藥品新增

<23S177> Safinamide mesilate(Equfina®) (50mg).錠

新藥介紹

<23S177> Safinamide mesilate(Equfina®) (50mg).錠

藥理作用/作用機轉

Inhibitor of MAO-B. Plasma concentrations achieved via administration in recommended doses (≤100 mg/day) confer selective inhibition of MAO-B activity, blocking the catabolism of dopamine, resulting in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain. The precise mechanism by which safinamide exerts its effect in Parkinson disease is unknown.

適應症/

劑量

PO

【Adult】

　●Parkinson disease: 50 mg QD (in combination with carbidopa/levodopa); after 2 weeks may increase to 100 mg QD (in combination with carbidopa/levodopa) based on response and tolerability.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

Moderate impairment: Maximum dose: 50 mg QD.

Severe impairment: Use is contraindicated by the manufacturer.

使用禁忌

Hypersensitivity to Equfina; severe hepatic impairment; use with methylphenidate, amphetamine, and their derivatives, or dextromethorphan; use with/within 2 weeks of other MAOIs/other drugs that are potent MAOI (including linezolid), opioids (eg, meperidine, methadone, propoxyphene, tramadol), SNRI, tricyclic/tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine.

警告/預防

CNS depression, Dyskinesia, Hypertension, Impulse control disorders, Serotonin syndrome

不良反應

【>10%】Dyskinesia

【1% to 10%】 Hypertension, orthostatic hypotension, dyspepsia, nausea, increased serum ALT/AST, anxiety, falling, insomnia, cough

【Frequency not defined】Impulse control disorder, sudden onset of sleep, headache

懷孕用藥分級(FDA)

C /避免使用，除非有治療必要

健保規範

l   藥品說明：與levodopa併用，每日限使用1錠。若每日需使用2錠，應於病歷上詳細記載理由。

l   藥品理由：與levodopa併用治療帕金森氏症

其他

治療期間採取適當的避孕措施

若出現不尋常之行為表現, 請告知醫師

視網膜疾病史的病人請告知醫師