Label Changes for:
Atrovent HFA (Ipratropium Bromide HFA) Inhalation Aerosol
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…
- Atrovent HFA is an anticholinergic and its use may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma…