Label Changes for:

Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol

June 2009

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

WARNINGS

Cardiovascular Effect
  • There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol.
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