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BEVESPI AEROSPHERE PRESCRIBING INFORMATION

US-47653. HIGHLIGHTS OF PRESCRIBING INFORMATION If paradoxical bronchospasm occurs, discontinue BEVESPI AEROSPHERE and These highlights do not include all the INFORMATION needed to use institute alternative therapy. ( ). BEVESPI AEROSPHERE safely and effectively. See full PRESCRIBING INFORMATION for Use with caution in patients with cardiovascular disorders. ( ). BEVESPI AEROSPHERE . Worsening of narrow-angle glaucoma may occur. Use with caution in patients with BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) inhalation aerosol, narrow-angle glaucoma and instruct patients to contact a physician immediately if for oral inhalation use symptoms occur. ( ). Initial Approval: 2016 Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a physician ------------------------------------RECE NT MAJOR CHANGES--------------------------------- ---- immediately if symptoms occur.

5.5 Hypersensitivity Reactions including Anaphylaxis 5.6 Cardiovascular Effects 5.7 Worsening of Narrow-Angle Glaucoma 5.8 Worsening of Urinary Retention 5.9 Coexisting Conditions 5.10 Hypokalemia and Hyperglycemia. 6 ADVERSE REACTIONS. 6.1 Clinical Trials Experience 6.2 Postmarketing Experience. 7 DRUG INTERACTIONS. 7.1 Adrenergic Drugs

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  Reactions, Anaphylaxis

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