warnings and cautions
5 WARNINGS AND PRECAUTIONS • Not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response ( 5.1 ) • Hypersensitivity reactions including anaphylaxis: Discontinue ipratropium bromide HFA inhalation aerosol at once and consider alternative treatments ( 5.2 ) • Paradoxical bronchospasm: Discontinue ipratropium bromide HFA inhalation aerosol and consider other treatments if paradoxical bronchospasm occurs ( 5.3 ) • Ocular effects: Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if signs or symptoms of narrow-angle glaucoma develop ( 5.4 ) • Urinary retention: Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if signs or symptoms of urinary retention develop ( 5.5 ) 5.1 Use for Maintenance Treatment Only Ipratropium bromide HFA inhalation aerosol 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. 5.2 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after the administration of ipratropium bromide HFA inhalation aerosol. In clinical trials and postmarketing 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 [see Adverse Reactions ( 6.1 , 6.2 )]. If such a reaction occurs, therapy with ipratropium bromide HFA inhalation aerosol should be stopped at once and alternative treatment should be considered [see Contraindications ( 4 )]. 5.3 Paradoxical Bronchospasm Ipratropium bromide HFA inhalation aerosol can produce paradoxical bronchospasm that can be life threatening. If this occurs, treatment with ipratropium bromide HFA inhalation aerosol should be stopped and other treatments considered. 5.4 Ocular Effects Ipratropium bromide HFA inhalation aerosol is an anticholinergic and its use may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, ipratropium bromide HFA inhalation aerosol should be used with caution in patients with narrow-angle glaucoma [see Drug Interactions ( 7.1 )]. Patients should avoid spraying ipratropium bromide HFA inhalation aerosol into their eyes. If a patient sprays ipratropium bromide HFA inhalation aerosol into their eyes, they 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 ipratropium bromide HFA inhalation aerosol. 5.5 Urinary Retention Ipratropium bromide HFA inhalation aerosol is an anticholinergic and may cause urinary retention. Therefore caution is advised when administering ipratropium bromide HFA inhalation aerosol to patients with prostatic hyperplasia, or bladder-neck obstruction [see Drug Interactions ( 7.1 )].