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Combivent

[ipratropium bromide and albuterol sulfate]

Anticholinergic agents

Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of Combivent Inhalation Aerosol with other anticholinergic-containing drugs.

Beta-adrenergic agents:

Text Continues Below



Caution is advised in the co-administration of Combivent Inhalation Aerosol and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects. Beta-receptor blocking agents and albuterol inhibit the effect of each other. Beta-receptor blocking agents should be used with caution in patients with hyperreactive airways.

Diuretics

The ECG changes and/ or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta agonist-containing drugs, such as Combivent Inhalation Aerosol, with non-potassium sparing diuretics.

Monoamine oxidase inhibitors or tricyclic antidepressants:

Combivent Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within two weeks of discontinuation of such agents because the action of albuterol on the cardiovascular system may be potentiated.

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.

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