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Albuterol: Pregnancy Category C. Albuterol has been shown to be teratogenic in mice. A reproduction study in CD-1 mice given albuterol subcutaneously (0. 025, 0.25 and 2. 5 mg/ kg) showed cleft palate formation in 5 of 111 (4. 5%) fetuses at 0. 25 mg/ kg (equivalent to the maximum recommended human daily inhalation dose on a mg/ m 2 basis) and in 10 of 108 (9. 3%) fetuses at 2.5 mg/ kg (approximately 10 times the maximum recommended human daily inhalation dose on a mg/ m 2 basis). None was observed at 0.025 mg/ kg (approximately one-tenth the maximum recommended human daily inhalation dose). Cleft palate also occurred in 22 of 72 (30.5%) fetuses treated with 2.5 mg/ kg isoproterenol (positive control). A reproduction study with oral albuterol in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses at 50 mg/ kg (approximately 1000 times the maximum recommended human daily inhalation dose on a mg/ m 2 basis). Text Continues Below
There are, however, no adequate and well-controlled studies of Combivent Inhalation Aerosol, ipratropium bromide or albuterol sulfate, in pregnant women. Because animal reproduction studies are not always predictive of human response, Combivent Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Labor and Delivery Because of the potential for beta-agonist interference with uterine contractility, use of Combivent Inhalation Aerosol for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Nursing Mothers It is not known whether the components of Combivent Inhalation Aerosol are excreted in human milk. Ipratropium bromide: 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 Combivent Inhalation Aerosol is administered to a nursing mother. Albuterol: Because of the potential for tumorigenicity shown for albuterol in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of Combivent Inhalation Aerosol in pediatric patients have not been established. Page: << Prev | 1 | 2 | 3 | 4
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