Label Changes for:

Combivent (Ipratropium Bromide and Albuterol Sulfate) Aerosol

August 2012

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

 

August 2012

 

ADVERSE REACTIONS

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

 

April 2011

 

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.”

 

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