【药效类别】支气管扩张药

【通用药名】FORMOTEROL FUMARATE

【化学名称】N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[(1RS)-2-(4-methoxyphenyl)-1-methylethylamino]ethyl]phenyl]-formamide hemifumarate

【CA登记号】[43229-80-7]

【分 子 式】(C19H24N2O4)2﹒C4H4O4

【分 子 量】804.88

【收录药典】JP14

【简介】
    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。

【原产地英文商品名】PERFOROMIST INHALATION SOLUTION 20MCG/2ML/VIAL 60VIALS/BOX
【原产地英文药品名】FORMOTEROL FUMARATE
【中文参考商品译名】PERFOROMIST溶液吸入剂 20微克/2毫升/瓶 60瓶/盒
【中文参考药品译名】富马酸福莫特罗
【生产厂家中文参考译名】DEY PHARMA
【生产厂家英文名】DEY PHARMA

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 medication

IMPORTANT LIMITATIONS OF USE
Deteriorating 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 Drugs
PERFOROMIST 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%).