COMBIVENT RESPIMAT-ipratropium bromide and albuterol sulfate spray, metered  Boehringer Ingelheim Pharmaceuticals Inc. Indication for Use COMBIVENT RESPIMAT is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. Important Safety Information COMBIVENT RESPIMAT is contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives. COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, therapy with COMBIVENT RESPIMAT should be discontinued immediately and alternative therapy instituted. The albuterol sulfate contained in COMBIVENT RESPIMAT can produce a clinically significant cardiovascular effect in some patients. If cardiovascular symptoms occur, COMBIVENT RESPIMAT may need to be discontinued. COMBIVENT RESPIMAT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. COMBIVENT RESPIMAT contains ipratropium bromide and may increase intraocular pressure which may result in precipitation or worsening of narrow-angle glaucoma. Patients should avoid spraying the aerosol into their eyes as this may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjunctival or corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using COMBIVENT RESPIMAT. Ipratropium bromide also may cause urinary retention. COMBIVENT RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction. Since dizziness and blurred vision may occur with the use of COMBIVENT RESPIMAT, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Do not exceed recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur. If such a reaction occurs, therapy with COMBIVENT RESPIMAT should be stopped at once and alternative treatment should be considered. COMBIVENT RESPIMAT contains albuterol and should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Albuterol may produce significant hypokalemia in some patients. In clinical trials, the most common adverse reactions reported for COMBIVENT RESPIMAT were upper respiratory tract infection, nasopharyngitis, cough, bronchitis, headache, and dyspnea. COMBIVENT RESPIMAT may interact additively with concomitantly used anticholinergic medications. Avoid co-administration with other anticholinergic-containing drugs. Caution is advised in co-administration of other beta-adrenergic agents, beta-receptor blocking agents, and non-potassium sparing diuretics. Extreme caution is advised with monoamine oxidase inhibitors or tricyclic antidepressants. COMBIVENT RESPIMAT Rx Generic Name and Formulations: Ipratropium bromide 20mcg, albuterol 100mcg (equivalent to 120mcg albuterol sulfate); per actuation; inhalation spray; CFC-free. Company: Boehringer Ingelheim Pharmaceuticals Indications for COMBIVENT RESPIMAT: COPD when a second aerosol bronchodilator is needed. Adult Dose for COMBIVENT RESPIMAT: 1 inh 4 times daily; max 6 inh/day. Children's Dose for COMBIVENT RESPIMAT: Not established. Pharmacological Class: Anticholinergic + beta-2 agonist. Contraindications: Atropine allergy. Warnings/Precautions: Avoid excessive use. Discontinue if paradoxical bronchospasm occurs. Cardiovascular disorders. Arrhythmias. Hypertension. Diabetes. Hyperthyroidism. Seizure disorders. Sensitivity to sympthomimetic amines. Narrow angle glaucoma. GI or GU obstruction. Hepatic or renal disease. Pregnancy (Cat. C). Labor & delivery. Nursing mothers: not recommended. Interactions: Extreme caution within 2 weeks of MAOIs or tricyclic antidepressants (increased cardiovascular effects). Caution with other anticholinergics, sympathomimetics, drugs that lower serum potassium. Antagonized by beta-blockers. Adverse Reactions: Upper respiratory infection, nasopharyngitis, cough, bronchitis, headache, dyspnea; paradoxical bronchospasm, urinary retention, hypokalemia, hypersensitivity reactions, ocular effects. Elimination: Ipratropium bromide: renal. Generic Availability: NO How Supplied: Inhaler—4g (120 inh) 美国推出COPD药物Combivent Respima喷雾剂 2012年9月18日,在美国推出慢性阻塞性肺病（COPD）药物Combivent Respima（异丙托溴铵+沙丁胺醇），这是一种独特的、无推进剂吸入性药物，利用一种缓慢移动的雾气来递送与COMBIVENT Inhalation Aerosol 相同的活性成分，后者通过一种计量吸入器（Combivent MDI）递送药物。 目前，Combivent Respimat已上市，同时Combivent MDI将于2013年7月退市。届时Combivent Respimat将是市面上唯一的Combivent产品。 Combivent Respimat和Combivent MDI是唯一能通过单一吸入器递送2种不同药物的短效支气管扩张剂产品。在COPD患者中开展的临床研究表明，相对于任意单一用药，异丙托溴铵和硫酸沙丁胺醇联合用药能够为患者提供更显着的肺功能改善。 在一项为期12周的随机、双盲、安慰剂和活性药物对照临床试验中，以FEV1为指标，Combivent Respima达到了与Combivent MDI相当的临床疗效。FEV1(Forced expiratory volume in one second)，一秒用力呼气容积，即吸气至肺总量位后一秒之内快速呼出气量。