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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. Albuterol: Like other agents in its class, albuterol caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium in a two-year study in the rat at dietary doses of 2, 10 and 50 mg/ kg/ day (approximately 20, 100 and 500 times the maximum recommended human daily inhalation dose on a mg/ m 2 basis). In another study this effect was blocked by the co-administration of propranolol. The relevance of these findings to humans is not known. An 18-month study in mice at dietary doses up to 500 mg/ kg/ day (approximately 2500 times the maximum recommended human daily inhalation dose on a mg/ m 2 basis) and a 99-week study in hamsters at oral doses up to 50 mg/ kg/ day (approximately 375 times the maximum recommended human daily inhalation dose on a mg/ m 2 basis) revealed no evidence of tumorigenicity. Studies with albuterol revealed no evidence of mutagenesis. Reproduction studies in rats with albuterol sulfate revealed no evidence of impaired fertility. Text Continues Below
Pregnancy TERATOGENIC EFFECTS Pregnancy Category C 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. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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