沙芬酰胺甲磺酸盐 Safinamide mesilate 商标名 Xadago 参比制剂 欧美产品，一次性进口，平价供应
英文药名：Safinamide mesilate
商标名称：Xadago
中文药名：沙芬酰胺片（沙芬酰胺甲磺酸盐）
生产厂家：赞邦公司
上市地区：美国，德国
剂型：薄膜衣片
包装规格
50mg*30st
50mg*100st
100mg*30st
药品介绍
Xadago（沙芬酰胺）的新药批准治疗特发性帕金森
Xadago（沙非酰胺）是α-氨基酰胺的发展作为一个附加的治疗多巴胺受体激动剂或左旋多巴患者早期或中期到晚期帕金森氏病。
批准的适应症：
用于治疗成年患者特发性帕金森氏病为附加到左旋多巴（L-多巴）单独或与其他抗帕金森病药物的患者，疾病的中级或高级的阶段组合施用稳定剂量。
活性物质是沙非酰胺，MAO-B（单胺氧化酶B）的产生增加纹状体中细胞外多巴胺水平的高度选择性可逆抑制剂。它也与抑制电压依赖性钠通道和谷氨酸释放的调节有关。
在的safinamide临床试验已经表明，以改善“接通”时间的患者运动波动，当前与单独的或与其他抗帕金森病药物的组合左旋多巴治疗。
临床开发过程中观察到的最常见的不良反应为运动障碍，嗜睡，头晕，头痛，失眠，恶心，体位性低血压“
沙芬酰胺抑制MAO-B（酶，能分解多巴胺）作为行动的原因及其机理增加多巴胺水平，防止其破坏。
Xadago（沙芬酰胺）接受在欧洲层面去年2014年12月18日由CHMP（委员会医药产品人用）的批准。
（要添加药物）批准帕金森治疗作为添加剂左旋多巴（L-多巴）单独或与其他药物。
这种新药（沙非酰胺）的个人资料已经被证明在长期（超过两年）有效批准.The决定是基于第三阶段两个国际研究安慰剂对照的1100多例帕金森。
Xadago（沙芬酰胺）将由赞邦研制的包衣片剂：50毫克和100毫克
Xadago(Safinamide Tablets)
XADAGO Rx
Generic Name and Formulations:
Safinamide 50mg, 100mg; tabs.
Company:
US WorldMeds, LLC
Indications for XADAGO:
As adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
Limitations Of use:
Not effective as monotherapy for treating Parkinson's disease.
Adult:
Initially 50mg once daily (at same time of day); may increase to 100mg once daily after 2 weeks as tolerated. Moderate hepatic impairment (Child-Pugh B): max 50mg once daily. Taper gradually upon discontinuation.
Children:
Not established.
Contraindications:
Severe hepatic impairment (Child-Pugh C). Concomitant other MAOIs including linezolid, opioids (eg, meperidine, methadone, propoxyphene, tramadol), SNRIs, tricyclic, tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine and their derivatives, St. John's wort, dextromethorphan.
Warnings/Precautions:
Monitor for new onset or uncontrolled hypertension. Avoid tyramine-rich (>150mg) foods (see full labeling). Dyskinesia: reduce daily dose of levodopa or dopaminergic agent. Consider reducing dose or discontinuing therapy if hallucinations, psychotic disorders, urges/compulsive behaviors develop. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep occurs. History of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, active retinopathy; monitor periodically for visual changes. Discontinue if severe hepatic impairment develops. Pregnancy (Cat.C). Nursing mothers: not recommended.
Pharmacological Class:
MAO-B inhibitor.
Interactions:
See Contraindications. Allow at least 14 days after discontinuing safinamide before starting MAOIs, opioids, serotonergics. Possible hypertensive crisis with excess dietary tyramine (see full labeling). Monitor for hypertension and reaction to dietary tyramine if concomitant with isoniazid. Concomitant SSRIs: use lowest effective dose and monitor for serotonin syndrome. Monitor for hypertension if concomitant with sympathomimetics (eg, nasal, oral, ophthalmic, decongestants or cold remedies). Concomitant with BCRP substrates (eg, methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan); monitor. May be antagonized by dopamine antagonists (eg, antipsychotics, metoclopramide).
Adverse Reactions:
Dyskinesia, fall, nausea, insomnia; serotonin syndrome, withdrawal-emergent hyperpyrexia and confusion, retinal pathology.
Generic Availability:
NO
How Supplied:
Tabs—30, 90
