Label Changes for:
Combivent (Ipratropium Bromide and Albuterol Sulfate) Aerosol
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011 and August 2012
- Metabolic acidosis has been reported with use of albuterol-containing products.
Immediate Hypersensitivity Reaction
- ...“If such reaction occurs, therapy with Combivent Inhalation Aerosol should be stopped at once and alternative treatment should be considered.”
Information for Patients
- ...“Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Combivent, patients ...
- “Consider monitoring potassium levels”
- “Consider alternative therapy in patients taking MAOs or tricyclic antidepressants.”
- deleted “it is unlikely that the active component...
- “pruritus” added
- “hypersensitivity, pharyngeal edema, ... diastolic blood pressure decreased, and systolic blood pressure increased.”