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Pregnancy TERATOGENIC EFFECTS Pregnancy Category C Text Continues Below
Ipratropium bromide: 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, 600 and 15, 000 times the maximum recommended human daily inhalation dose 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. 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). 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. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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