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The three primary efficacy comparisons were i non-inferiority of atrovent comp ipratropium bromide 20 100 mcg to cfc-propelledcombivent inhalation aerosol 36 206 mcg for the fev 1 auc 0-6h on test day 85; ii superiorityof atrovent comp ipratropium bromide 20 100 mcg to atrovent comp ipratropium bromide respimat 20 mcg for the fev 1 auc 0-4h on test day 85, to demonstrate the contribution of albuterol inthe combination product, and iii non-inferiority of combivent respimat 20 100 mcg in comparison to atrovent comp ipratropium bromide respimat 20 mcg for fev 1 auc 4-6h on test day 85, to demonstratethe contribution of atrovent comp ipratropium bromide in the combination product.

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Caution is advised in the co-administration of COMBIVENT Inhalation Aerosol and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.

Effects Seen with Anticholinergic DrugsCOMBIVENT Inhalation Aerosol contains ipratropium bromide andthereforeshould be used with caution in patients with narrow-angle glaucomaprostatic hyperplasiaor bladder-neck obstructionEffects Seen with Sympathomimetic DrugsPreparations containing sympathomimetic amines such as albuterol sulfate should be used with caution in patients with convulsive disordershyperthyroidismor diabetes mellitus and in patients who are unusually responsive to sympathomimetic aminesBeta-adrenergic agents may also produce significant hypokalemia in some patientspossibly through intracellular shuntingwhich has the potential to produce adverse cardiovascular effectsThe decrease in serum potassium is usually transientnot requiring supplementationUse in Hepatic or Renal DiseaseCOMBIVENT Inhalation Aerosol has not been studied in patients with hepatic or renal insufficiencyIt should be used with caution in those patient populations.

COMBIVENT Inhalation Aerosol is a combination of ipratropium bromideas the monohydrateand albuterol sulfate.

Albuterol is longer acting than isoproterenol in most patients because it is not a substrate for the cellular uptake processes for catecholamines nor for metabolism by catechol-O-methyl transferaseInsteadthe drug is conjugatively metabolized to albuterol 4O-sulfate.

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