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/m2 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/m2 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/m2 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/m2 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/m2 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.
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