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U.S. Department of Health and Human Services


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Combivent Inhalation Aerosol (ipratropium bromide and albuterol sulfate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View


Sections Modified


  • Information for Patients
    • ...mydriasis, increased intraocular pressure, acute eye pain or discomfort...
    • ...Patient's should also be advised that should any combination of these symptoms develop, they should consult their physician immediately...
  • Drug Interactions
    • ...oral and inhaled steroids...
    • ...With the exception of albuterol, there are no formal studies fully evaluating the interaction effects of Combivent Inhalation Aerosol and these drugs with respect to effectiveness.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • Ipratropium bromide
    • Albuterol
  • Pregnancy
    • Combivent Inhalation Aerosol
    • Ipratropium bromide
    • Albuterol


  • Postmarketing Experience


  • Avoid spraying in eyes.
  • Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.