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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 potentiatedConsider alternative therapy in patients taking MAOs or tricyclic antidepressants.
Studies in laboratory animalsminipigsrodentsand dogshave demonstrated the occurrence of cardiac arrhythmias and sudden deathwith histologic evidence of myocardial necrosiswhen beta-agonists and methylxanthines were administered concurrentlyThe significance of these findings when applied . to humans is unknown.
In the 2 controlled 12-week studiesCOMBIVENT Inhalation Aerosol did not produce any change in the secondary efficacy parameters including symptom scoresphysician global assessments and morning PEFRall of which were monitored throughout the study period.
Since dizzinessaccommodation disordermydriasisand blurred vision may occur with use of COMBIVENTpatients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.
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because lipid-insoluble quaternary cations pass into breast milk, caution should be exercised when combivent inhalation aerosol is administered to a nursing mother.