近日，美国食品和药物管理局(FDA)批准ATROVENT HFA（Ipratropium Bromide）吸入气雾剂，用于治疗慢性支气管炎和肺气肿等慢性阻塞性肺疾病(COPD)引起的支气管痉挛。
批准日期：2004年11月18日 公司：BOEHRINGER INGELHEIM
ATROVENT® HFA（异丙托溴铵[ipratropium bromide]）吸入气雾剂，用于口服吸入
美国最初批准：2004
作用机制
异丙托溴铵是一种抗胆碱能（副交感神经）药物，根据动物研究，它似乎通过拮抗乙酰胆碱的作用来抑制迷走神经介导的反射，乙酰胆碱是在肺神经肌肉接头处释放的递质剂。抗胆碱能药可防止因乙酰胆碱与支气管平滑肌上的毒蕈碱受体相互作用而引起的细胞内Ca++浓度的增加。
适应症和用法
ATROVENT HFA是一种抗胆碱能药，用于维持治疗与慢性阻塞性肺疾病(COPD)相关的支气管痉挛，包括慢性支气管炎和肺气肿。
剂量和给药
仅用于口服吸入
每天四次吸入两次，24小时内不超过12次吸入。
剂型和规格
吸入气雾剂：每次启动 ATROVENT HFA吸入气雾剂时，都会从咬嘴中输送17微克异丙托溴铵。装在一个12.9克的罐中，装有200个驱动器。
禁忌症
对异丙托溴铵或其他ATROVENT HFA成分过敏。
对阿托品或其任何衍生物过敏。
警告和注意事项
不适用于需要急救治疗以获得快速反应的支气管痉挛急性发作的初始治疗。
包括过敏反应在内的超敏反应：立即停用 ATROVENT HFA并考虑替代治疗。
矛盾性支气管痉挛：如果出现矛盾性支气管痉挛，停止ATROVENT HFA并考虑其他治疗。
眼部影响：窄角型青光眼患者慎用，并指导患者在出现窄角型青光眼的体征或症状时立即就医。
尿潴留：前列腺增生或膀胱颈梗阻患者慎用，并指导患者在出现尿潴留体征或症状时立即就医。
不良反应
最常见的不良反应（在12周安慰剂对照试验中发生率 >5%）是支气管炎、COPD恶化、呼吸困难和头痛。
包装供应/储存和处理
产品：
00597-0087-17 200气溶胶，计量装在罐中/1个装在纸箱中
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae462cd6-615b-4f0d-ae6e-59007e7acab0&version=3
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提示：以下产品专供研究单位。价格仅供参考，采购者以在线咨询为准！
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ATROVENT HFA INH AERO 12.9GM IPRATROPIUM BROMIDE 持证商：BOEHRINGER INGELHEIM NDC:00597-0087-17 参考价格（美元）：509.63
ATROVENT NASAL SPR .03% 30ML IPRATROPIUM BROMIDE 持证商：BOEHRINGER INGELHEIM NDC:00597-0081-30 参考价格（美元）：284.89
ATROVENT NASAL SPR .06% 15ML PRATROPIUM BROMIDE 持证商：BOEHRINGER INGELHEIM  NDC:00597-0086-76 参考价格（美元）：157.68
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INDICATION
Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
IMPORTANT SAFETY INFORMATION
ATROVENT HFA is contraindicated in patients with a history of hypersensitivity to ipratropium, other ATROVENT HFA components, or atropine or any of its derivatives.
ATROVENT HFA is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.
Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after the administration of ATROVENT HFA. In clinical trials and post marketing experience with ipratropium containing products, hypersensitivity reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported. If such a reaction occurs, therapy with ATROVENT HFA should be stopped at once and alternative treatment should be considered.
ATROVENT HFA can produce paradoxical bronchospasm that can be life threatening. If this occurs, treatment with ATROVENT HFA should be stopped and other treatments considered.
ATROVENT HFA may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, ATROVENT HFA should be used with caution in patients with narrow-angle glaucoma.
Patients should avoid spraying ATROVENT HFA into their eyes. If a patient sprays ATROVENT HFA into their eyes, this may cause eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using ATROVENT HFA.
ATROVENT HFA may cause urinary retention. Therefore caution is advised when administering ATROVENT HFA to patients with prostatic hyperplasia, or bladder-neck obstruction.
The most common adverse reactions (>5% incidence in the 12-week placebo-controlled trials) with ATROVENT HFA (placebo) were bronchitis 10% (6%), COPD exacerbations 8% (13%), dyspnea 8% (4%) and headache 6% (8%).
ATROVENT HFA may interact additively with concomitantly used anticholinergic medications. Avoid administration of ATROVENT HFA with other anticholinergic-containing drugs.