Ipratropium precautions

List of precautions
General Eyes Drug safety Carcinogenesis Mutagenesis Impairment of fertility Pregnancy Nursing mothers Pediatric use

General
Ipratropium bromide should be used with caution in patients with narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction. Return to top

Eyes
Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with a mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Return to top

Drug safety
Patients should be advised that Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that Ipratropium Bromide Inhalation Solution should be used consistently as prescribed throughout the course of therapy. Return to top

Carcinogenesis
Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of Ipratropium bromide. Return to top

Mutagenesis
Results of various mutagenicity studies (Ames test, mouse dominate lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative. Return to top

Impairment of fertility
Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by Ipratropium bromide administration. At doses above 90 mg/kg, increased resorption and decreased conception rates were observed. Return to top

Pregnancy
Teratogenic Effects
 * Pregnancy Category B. Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, 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, Ipratropium bromide should be used during pregnancy only if clearly needed. Return to top

Nursing mothers
It is not known whether Ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when Ipratropium bromide is administered to a nursing woman. Return to top

Pediatric use
Safety and effectiveness in the pediatric population below the age of 12 have not been established. Return to top