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warnings
WARNINGS ATROVENT (ipratropium bromide) Inhalation Aerosol is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. Immediate Hypersensitivity Reactions : Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema. Storage Conditions : The contents of ATROVENT Inhalation Aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120° F may cause bursting. Never throw the container into a fire or incinerator. Keep out of reach of children.
ADVERSE REACTIONS Adverse reaction information concerning ATROVENT (ipratropium bromide) Inhalation Aerosol is derived from 90 day controlled clinical trials (N=254), other controlled clinical trials using recommended doses of ATROVENT Inhalation Aerosol (N=377) and an uncontrolled study (N=1924). Additional information is derived from the post-marketing experience and the published literature. Adverse reactions occurring in greater than one percent of patients in the 90 day controlled clinical trials appear in Table 1. Table 1 Adverse Reactions Occurring in >1% of COPD Patients Percent of Patients Ipratropium Bromide Metaproterenol Sulfate N = 254 N= 249 Reaction Cardiovascular Palpitations 1.8 1.6 Central Nervous System Nervousness 3.1 6.8 Dizziness 2.4 2.8 Headache 2.4 2.0 Dermatological Rash 1.2 0.4 Gastrointestinal Nausea 2.8 1.2 Gastrointestinal distress 2.4 2.8 Vomiting 0 1.2 Musculoskeletal Tremor 0 2.4 Ophthalmological Blurred vision 1.2 0.8 Oro-Otolaryngeal Dry mouth 2.4 0.8 Irritation from aerosol 1.6 1.6 Respiratory Cough 5.9 1.2 Exacerbation of symptoms 2.4 3.6 Additional adverse reactions reported in less than one percent of the patients considered possibly due to ATROVENT Inhalation Aerosol include urinary difficulty, fatigue, insomnia and hoarseness. The large uncontrolled, open-label study included seriously ill patients. About 7% of patients treated discontinued the program because of adverse events. Of the 2301 patients treated in the large uncontrolled study and in clinical trials other than the 90 day studies, the most common adverse reactions reported were: dryness of the oropharynx, about 5 in 100; cough, exacerbation of symptoms and irritation from aerosol, each about 3 in 100; headache, about 2 in 100; nausea, dizziness, blurred vision/difficulty in accommodation, and drying of secretions, each about 1 in 100. Less frequently reported adverse reactions that were possibly due to ATROVENT (ipratropium bromide) Inhalation Aerosol include tachycardia, paresthesia, drowsiness, coordination difficulty, itching, hives, flushing, alopecia, constipation, tremor, and mucosal ulcers. Cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, and hypotension, have been reported. In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and atrial fibrillation occurred with an incidence rate of 0.5% in patients receiving ATROVENT Inhalation Aerosol. Post-Marketing Experience Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported, with positive rechallenge in some cases. Many of the patients had a history of allergies to other drugs and/or foods, including soybean. (See CONTRAINDICATIONS ). Additionally, urinary retention, mydriasis, and bronchospasm, including paradoxical bronchospasm, have been reported during the post-marketing period.