Label Changes for:

Atrovent HFA (Ipratropium Bromide HFA) Inhalation Aerosol

August 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions, Including Anaphylaxis
  • Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after the administration of Atrovent HFA…
Ocular Effects
  • Atrovent HFA is an anticholinergic and its use may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma…

 

Hide
(web3)