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warnings and cautions
5 WARNINGS AND PRECAUTIONS Tachycardia ( 5.1 ) Glaucoma ( 5.2 ) Pyloric obstruction ( 5.3 ) Worsening urinary retention ( 5.4 ) Viscid bronchial plugs ( 5.5 ) 5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. 5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
6 ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation. Most adverse reactions are directly related to atropine's antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .