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英文药名：PERFOROMIST(formoterol fumarate Inhalation Solution)
中文药名：富马酸福莫特罗吸入溶液
生产厂家：Mylan Specialty L.P
药品介绍
富马酸福莫特罗喷雾剂（Perforomist, Dey, Napa, California），可以用于慢性阻塞性肺疾病（COPD），包括慢性支气管炎和肺气肿。它是有效的支气管扩张药，可以快速起效（给药后约5分钟起效），并且作用时间较长（作用时间约为12h）。在一项针对老年COPD病人（平均年龄62.8岁）的试验中，试验者接受一天两次为期12周的喷雾治疗，没有发现对心脏的不良影响。
福莫特罗(formoterol)，化学名称为3-甲酰胺基-4-羟基-α-[N-[1-甲基-2-(p-甲氧基苯基)乙基]胺基甲基]苄醇，是一种长效β<,2>受体激动药，可用于治疗支气管哮喘，特别是在控制夜间哮喘病症状有着独一无二的作用；同时它毒副作用低，不良反应低于其它同类抗哮喘药物，因此特别适合儿童使用。福莫特罗还可制作为吸入剂剂型，这是治疗支气管哮喘的最好给药方式。
处方修改批准日期：2013年3月 公司：Mylan Specialty L.P
PERFOROMIST®（富马酸福莫特罗[formoterol fumarate]）吸入溶液
最初美国批准：2001年
警告：
与哮喘有关的DEATHSee完整处方完整黑框警告信息。
•长效β2-肾上腺素受体激动剂（LABA）增加哮喘相关死亡的风险。
•与其他长效β2-肾上腺素能激动剂（沙美特罗），安慰剂对照研究显示，接受中沙美特罗的患者与哮喘有关的死亡人数的增加。
•哮喘有关的死亡的沙美特罗的风险增加的发现被认为是LABA的一类效果，包括福莫特罗，在PERFOROMIST的活性成分。 PERFOROMIST的哮喘患者的安全性和疗效尚未确立。所有的LABA，包括PERFOROMIST，是禁忌哮喘患者不使用长期的哮喘控制药物。
作用机理
富马酸福莫特罗是长效β2-肾上腺素能受体激动剂（β2-激动剂）。吸入富马酸福莫特罗在肺的支气管扩张作用本地。体外研究已经表明，福莫特罗具有比在β1的受体超过200倍于β2 - 受体的更大的激动剂活性。虽然β2-受体是支气管平滑肌和β1受体的主要肾上腺素受体在心脏的主要受体，也存在β2-受体在人的心脏包括总β-肾上腺素能受体的10％至50％。这些受体的确切功能尚未确立，但他们提出，即使高选择性β2 - 激动剂可具有强心作用的可能性。
的β2 - 肾上腺素受体激动剂的药物，包括福莫特罗的药理作用，至少部分归因于细胞内腺苷酸环化酶的刺激作用，催化三磷酸腺苷（ATP）的，以环状3'，5'-单磷酸腺苷的转化（在酶环磷酸腺苷）。增加环状AMP水平引起支气管平滑肌和从细胞中速发型超敏反应的介质释放的抑制的松弛，尤其是肥大细胞。
体外试验表明，福莫特罗是肥大细胞介质，如组胺和白三烯的释放的抑制剂，从人肺。福莫特罗也抑制在麻醉的豚鼠的组胺诱发的血浆白蛋白外渗并抑制犬呼吸道高反应性过敏原诱导的嗜酸性粒细胞流入。这些在体外和动物研究结果与COPD的相关性，人类是未知的。
适应症和用法
PERFOROMIST吸入溶液是一种长效β2-肾上腺素能受体激动剂（β2-激动剂）为表示：
•长期，每天两次（早晚）管理的慢性阻塞性肺疾病（COPD），包括慢性支气管炎和肺气肿的维持治疗支气管收缩。
利用重要的限制：
•PERFOROMIST吸入溶液不表明治疗慢性阻塞性肺疾病急性恶化。
•PERFOROMIST吸入溶液不表明治疗哮喘。
用法用量
对于口腔吸入只。
•一个20微克/毫升2瓶，每12小时
•对于标准的喷射式雾化器（带口罩或口罩）连接到一个空气压缩机使用
剂型和规格
吸入溶液（单位剂量的小瓶喷雾）; 20微克/2毫升溶液。
禁忌症
•所有的LABA，包括PERFOROMIST，是禁忌哮喘患者不使用长期的哮喘控制药物。
警告和注意事项
•不要在急性恶化的病人开始PERFOROMIST吸入溶液。
•不要为急性症状缓解使用。根据需要为急性缓解可用于伴随短效β2-激动剂。
•不要超过推荐剂量。过度使用PERFOROMIST吸入溶液的，或者使用在与含长效β2 - 激动剂其它药物相结合，可以导致临床显著心血管作用，并可能是致命的。
•危及生命的矛盾性支气管痉挛可能发生。立即停止PERFOROMIST吸入溶液。
•与患者的心血管或惊厥性疾病，甲亢，或与拟交感神经药的敏感性请谨慎使用。
不良反应
最常见的不良反应（>2％，比安慰剂更常见）是腹泻，恶心，鼻咽炎，口干，呕吐，头晕，失眠。
药物相互作用
•其他拟肾上腺素药，会增强效果。请谨慎使用。
•黄嘌呤衍生物，类固醇，利尿剂，或非保钾利尿剂，会增强低钾或心电图变化。请谨慎使用。
•MAO抑制剂，即延长QT间期三环类抗抑郁药和药物会增强对心血管系统的影响。请务必谨慎使用。
•β受体阻滞剂会降低效率。谨慎，只有在必要的医疗使用。
包装规格/储存与处理
PERFOROMIST（富马酸福莫特罗）吸入溶液是作为在2.5毫升的低密度聚乙烯单位剂量小瓶中用于雾化一个2毫升无菌溶液。每个小瓶中的箔袋包住并在纸盒供给如下所示。
30个剂量(小瓶)纸箱，NDC 49502-605-30
60个剂量(小瓶)纸箱，NDC 49502-605-61
储存和处理：
此前配药给病人：应贮存在冰箱，2℃〜8°C（36°F至46°F）
储存于2°C至25°C（36°F至77°F）的长达3个月：分配到患者之后。防热袋。
•PERFOROMIST吸入溶液应该仅通过连接到空气压缩机具有足够的气流，并配有一个面罩或吹嘴标准喷射喷雾器给药。
PERFOROMIST(formoterol fumarate Inhalation Solution)
Important Safety Information
People with asthma who take long –acting beta2 adrenergic agonist (LABA) medicines such as PERFOROMIST have an increased risk of death from asthma problems. It is not known whether LABA medicines, such as PERFOROMIST, increase the risk of death in people with COPD. Get emergency medical care if breathing problems worsen quickly, or you use your rescue inhaler medicine but it does not relieve your breathing problems
INDICATION
PERFOROMIST (formoterol fumerate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death.
Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established.
All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medicationIMPORTANT LIMITATIONS OF USEDeteriorating COPD
PERFOROMIST Inhalation Solution should not be used in patients with rapidly worsening COPD, which may be a life-threatening condition.
Asthma
PERFOROMIST Inhalation Solution is not indicated to treat asthma.
The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.
CONTRAINDICATIONS
All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication.
WARNINGS AND PRECAUTIONS
PERFOROMIST Inhalation Solution should not used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with a short-acting beta2-agonist.
PERFOROMIST Inhalation Solution should not be used more often, or at higher doses than recommended, or with other medications containing long-acting beta2-agonists, at the same time because of the risk of an overdose. Serious heart effects and fatalities have been reported with too high doses of inhaled sympathomimetic drugs.
Paradoxical Bronchospasm
As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm (unexpected tightening of breathing tubes) that may be life threatening.
If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be immediately stopped and a different therapy started.
Cardiovascular Effects
PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce serious heart-related effects in some patients as measured by higher pulse rate and higher blood pressure.
PERFOROMIST Inhalation Solution should be used with caution in patients with heart disease, especially coronary insufficiency, cardiac arrhythmias, and high blood pressure; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to adrenaline-like drugs.
Coexisting Conditions
PERFOROMIST Inhalation Solution, like other sympathomimetic amine(adrenaline-like) drugs, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amine (adrenaline-like) drugs.
Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to worsen preexisting diabetes and ketoacidosis.
DRUG INTERACTIONS
MAO Inhibitors, Tricyclic Antidepressants and QTc Prolonging DrugsPERFOROMIST Inhalation Solution, like other beta2-agonists, should be used with extreme caution in patients being treated with certain monoamine oxidase inhibitors, tricyclic antidepressants or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be increased by these agents.
ADVERSE EVENTS
PERFOROMIST Inhalation Solution was studied in a 12-week, double-blind, placebo- and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). The most common adverse events reported in patients taking PERFOROMIST Inhalation Solution, and occurring more frequently than in patients taking placebo, were diarrhea (5%), nausea (5%), nasopharyngitis (3%), dry mouth (3%), dizziness (2%), and insomnia (2%).
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb2fe258-fe2e-47f6-8adf-ca75bf6f90af&audience=consumer
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