|
While you are taking Combivent Inhalation Aerosol, other inhaled drugs should be taken only as directed by your physician. If you are pregnant or nursing, contact your physician about use of Combivent Inhalation Aerosol. Appropriate use of Combivent Inhalation Aerosol includes an understanding of the way it should be administered (See Patient's Instructions for Use). Carcinogenesis, Mutagenesis, Impairment of Fertility Ipratropium bromide: 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 in rats and mice respectively, on a mg/ m 2 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. Text Continues Below
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. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
