Combivent (ipratropium bromide and albuterol sulfate) Aerosol

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011 and August 2012

 

August 2012

Summary View

 

ADVERSE REACTIONS

Post-Marketing Experience

• Metabolic acidosis has been reported with use of albuterol-containing products.

 

April 2011

Summary View

 

WARNINGS

Immediate Hypersensitivity Reaction

• ...“If such reaction occurs, therapy with Combivent Inhalation Aerosol should be stopped at once and alternative treatment should be considered.”

 

PRECAUTIONS

Information for Patients

• ...“Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Combivent, patients ...

Drug Interactions

• “Consider monitoring potassium levels”
• “Consider alternative therapy in patients taking MAOs or tricyclic antidepressants.”

Nursing Mothers

• deleted “it is unlikely that the active component...

 

ADVERSE REACTIONS

• “pruritus” added

Postmarketing Experiences

• “hypersensitivity, pharyngeal edema, ... diastolic blood pressure decreased, and systolic blood pressure increased.”