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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. PRECAUTIONS General Effects Seen with Anticholinergic Drugs : ATROVENT (ipratropium bromide) Inhalation Aerosol should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Information for Patients Patients should be cautioned to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucoma, mydriasis, eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately. ATROVENT Inhalation Aerosol should not be used more frequently than recommended. The dose or frequency of ATROVENT Inhalation Aerosol should not be increased without patients consulting their physician. If treatment with ATROVENT Inhalation Aerosol becomes less effective for symptomatic relief, their symptoms become worse, and/or patients need to use the product more frequently than usual, medical attention should be sought immediately. The patient, if pregnant or nursing, should be advised to contact their physician about the use of ATROVENT Inhalation Aerosol. Appropriate use of ATROVENT Inhalation Aerosol includes an understanding of the way it should be administered (See Patient's Instructions for Use ). Drug Interactions ATROVENT Inhalation Aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, and steroids, commonly used in the treatment of chronic obstructive pulmonary disease. With the exception of albuterol, there are no formal studies fully evaluating the interaction effects of ATROVENT Inhalation Aerosol and these drugs with respect to effectiveness. Anticholinergic agents : Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of ATROVENT Inhalation Aerosol with other anticholinergic-containing drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at doses up to 6 mg/kg/day. This dose corresponds to approximately 360 and 180 times the maximum recommended human daily inhalation dose of ipratropium bromide in rats and mice respectively, on a mg/m 2 basis. Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative. Fertility of male or female rats at oral doses up to 50 mg/kg/day (approximately 3000 times the maximum recommended human daily inhalation dose on a mg/m 2 basis) was unaffected by ipratropium bromide administration. At doses above 90 mg/kg/day (approximately 5400 times the maximum recommended human daily inhalation dose on a mg/m 2 basis), increased resorption and decreased conception rates were observed. Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies were performed at doses of 10 mg/kg in mice, 100 mg/kg in rats and 125 mg/kg in rabbits. These doses correspond, in each species, respectively, to approximately 300, 6000 and 15,000 times the maximum recommended human daily inhalation dose of ipratropium bromide on a mg/m 2 basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg/day (approximately 90 and 210 times the maximum recommended human daily inhalation dose on a mg/m 2 basis). These studies have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ATROVENT Inhalation Aerosol should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether ATROVENT Inhalation Aerosol is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that the active component, ipratropium bromide, would reach the infant to an important extent, especially when taken by aerosol. However, because many drugs are excreted in human milk, caution should be exercised when ATROVENT Inhalation Aerosol is administered to a nursing mother. Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
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.