Ipratropium Bromide Inhalation

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Ipratropium bromide HFA inhalation aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 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 Dosage and administration 2 DOSAGE AND ADMINISTRATION The usual starting dose of ipratropium bromide HFA inhalation aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Ipratropium bromide HFA inhalation aerosol is a solution aerosol that does not require shaking. However, as with any other metered-dose inhaler, some coordination is required between actuating the canister and inhaling the medication. Patients should “prime” or actuate ipratropium bromide HFA inhalation aerosol before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 test sprays into the air away from the face. Patients should avoid spraying ipratropium bromide HFA inhalation aerosol into their eyes. Each inhaler provides sufficient medication for 200 actuations. The inhaler should be discarded after the labeled number of actuations has been used. The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty. Patients should be instructed on the proper use of their inhaler [see Patient Counseling Information ( 17 )]. For oral inhalation only • Two inhalations four times a day, not to exceed 12 inhalations in 24 hours 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 inha