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.