• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

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

PRECAUTIONS

  • 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

ADVERSE REACTIONS

  • Postmarketing Experience

PATIENT PACKAGE INSERT

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