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当前位置:药品说明书与价格首页 >> 精神心理 >> 药品目录 >> 抗抑郁药类 >> EMSAM transdermal system(司来吉兰透皮系统)

EMSAM transdermal system(司来吉兰透皮系统)

2010-01-12 09:12:42  作者:新特药房  来源:中国新特药网  浏览次数:299  文字大小:【】【】【
简介:百时美施贵宝、Somerset(Mylan的合资公司)和华生制药三家公司昨天宣布,FDA已经批准Emsam(司来吉兰透皮剂)。这是第一种用于治疗成人重度抑郁症(MDD)的透皮贴片,由Mylan公司生产。 通过透皮给药 ...

EMSAM®(司来吉兰透皮系统)
EMSAM®(司来吉兰透皮系统)是一种使用单胺氧化酶抑制剂(MAOI)司来吉兰的透皮贴剂。 司来吉兰,小剂量,最常用于治疗帕金森病。用于治疗重症抑郁障碍的较高剂量中也是有效。
2006年2月28日,FDA批准用于治疗临床抑郁症的EMSAM。
EMSAM的优点
由于较新的SSRI和SNRIs的可用性,其被认为在抑郁症的治疗中具有更多的医学上良性的副作用,精神药理学家和精神病学家由于高血压危险的可能性避免了处方MAOI。使用EMSAM,以每24小时6mg的最低剂量服用,FDA不需要饮食修改
除了在6mg/24h剂量缺乏饮食限制,EMSAM提供另一个好处。它是一个连续的输送系统,保持药物在体内的稳定水平随着时间的推移。
通常,口服药物不能在血流中保持稳定的剂量。
EMSAM在治疗抑郁症中也是有价值的,其不被更常用的选择性5-羟色胺再摄取抑制剂(SSRI),双重5-羟色胺和去甲肾上腺素再吸收抑制剂(SNRI)和三环抗抑郁药(TCA)减轻。
用法
补丁每天更换一次。在应用部位可能对皮肤上的粘合剂有反应。鼓励患者使用去胶剂:通常为矿物油,Vaseline®或非处方产品,如皮肤病推荐的TRIAD®牌胶带去除垫。新的修补程序放在不同的网站上。粘合剂去除剂和将每个贴片放置在新的皮肤区域上的组合是阻止任何皮肤病学原因以中断贴剂。
在施用贴剂之前使用摩擦醇或过氧化氢清洁油和污垢的皮肤可以增加在每24小时期间的适当附着的可能性。在施用贴剂之后立即使用手掌的压力和体热以增强适当的粘合剂接触是有帮助的。
目前,FDA要求所有的饮食限制,作为预防使用,在较高的9mg/24h和12mg/24h剂量的EMSAM。
EMSAM(selegiline transdermal system)
Emsam is a transdermal patch that contains the medication selegiline. The patches are used to treat major depressive disorder in adults.  This medication stops the breakdown of the chemicals in that brain that are associated with depression.
Selegiline is also used to treat other disorders such as Parkinson’s disease and dementia.
Formula
Emsam’s active ingredient is selegiline.  Since this is not a tablet or capsule, but a transdermal patch, its composition is different than oral medications. The patch is comprised of three layers; a backing which protects the adhesive as well as the medication that is contained in the second layer. The third layer is a thin liner that releases the medication into the patient’s skin.
Dosage
The Emsam patch is designed to be worn for 24 hours and comes in a 6 mg, 9 mg or 12 mg patch dose. During this time there is a continuous release of the medication, selegiline. The patch should be replaced at the same time every day. If the patch falls off and will not stick to the skin, a new patch will need to be used.
EMSAM PATCH Rx
Generic Name and Formulations:
Selegiline 6mg/24hrs, 9mg/24hrs, 12mg/24hrs; transdermal patch.
Company:
Mylan Specialty L.P.

Select therapeutic use: Mood disorders
Indications for EMSAM:
Major depressive disorder.

Adult:
Initial: apply one 6mg/24hrs patch daily to dry, intact skin on upper torso, upper thigh, or outer surface of upper arm. May titrate at intervals of ≥2 weeks in increments of 3mg/24hrs; max 12mg/24hrs. Rotate application sites. Reevaluate periodically. Do not cut patches.

Children:
Not recommended.

Contraindications:
To avoid potentially severe or fatal interactions (hypertensive crisis and/or serotonin syndrome), allow sufficient drug-free interval (see literature) between selegiline and: fluoxetine, buspirone, SSRIs, serotonin/norepinephrine reuptake inhibitors, tricyclics, bupropion, meperidine, tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, mirtazapine, cyclobenzaprine, other MAOIs, carbamazepine, oxcarbazepine, amphetamines, other sympathomimetic amines (eg, pseudoephedrine), general anesthesia [esp for elective surgery], cocaine, local anesthetics containing sympathomimetic vasoconstrictors; others (see literature). Pheochromocytoma.

Warnings/Precautions:
Doses above 6mg/24hrs: see literature for tyramine dietary modifications. Avoid exposing patch to external heat sources. Mania/hypomania. Monitor for clinical worsening or suicidality. Recent MI. Unstable heart disease. Conditions that affect metabolism or hemodynamic response. Elderly (monitor BP). Pregnancy (Cat.C). Nursing mothers.

Interactions:
See Contraindications. Avoid alcohol, dietary supplements with tyramine.

Pharmacological Class:
MAOI.

Adverse Reactions:
Application site reaction, headache, insomnia, GI upset, dry mouth, rash, pharyngitis, sinusitis, orthostatic hypotension; others.

How Supplied:
Patches—30
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注:以下产品美国上市包装,不同规格和不同价格,采购以咨询为准
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EMSAM PATCH 12MG/24HR 1X30  SELEGILINE     49502-0902-30 


EMSAM PATCH 6MG/24HR 1X30  SELEGILINE     49502-0900-30 


EMSAM PATCH 9MG/24HR 1X30  SELEGILINE     49502-0901-30 


ESTRADIOL PATCH .1MG/DAY MYL8  ESTRADIOL     00378-4640-26 
ESTRADIOL PATCH 0.025/DAYALV4  ESTRADIOL     47781-0204-04 
ESTRADIOL PATCH 0.05/DAYALV 4  ESTRADIOL     47781-0206-04 
ESTRADIOL PATCH 0.05MG MYLN 4  ESTRADIOL     00378-3350-99 
ESTRADIOL PATCH 0.06/DAYALV 4  ESTRADIOL     47781-0207-04 
ESTRADIOL PATCH 0.075/DAYALV4  ESTRADIOL     47781-0208-04 
ESTRADIOL PATCH 0.1MG MYLN 4  ESTRADIOL     00378-3352-99 
ESTRADIOL PATCH 0.1MG/DAYALV4  ESTRADIOL     47781-0209-04 
ESTRADIOL PATCH0.0375/DAYALV4  ESTRADIOL     47781-0205-04 


EXELON PATCH 13.3MG/24HR 30  RIVASTIGMINE     00078-0503-15 
EXELON PATCH 4.6MG/24HR 30  RIVASTIGMINE     00078-0501-15 
EXELON PATCH 9.5MG/24HR 30  RIVASTIGMINE     00078-0502-15

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