5 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Armstrong Pharmaceuticals, Inc. gov/medwatch. 1 Clinical Trials Experience The adverse reaction information concerning ipratropium bromide HFA inhalation aerosol is derived from two 12-week, double-blind, parallel-group studies and one 1-year open-label, parallel group study.
These studies compared ipratropium bromide HFA inhalation aerosol, ipratropium bromide CFC inhalation aerosol, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group and greater than placebo in the 12-week study.
The frequency of corresponding reactions in the 1-year open label study is included for comparison. 2453 Ipratropium Bromide HFA Inhalation Aerosol (N=243) % Ipratropium Bromide CFC Inhalation Aerosol (N=183) % Placebo (N=128) % Ipratropium Bromide HFA Inhalation Aerosol (N=305) % Ipratropium Bromide CFC Inhalation Aerosol (N=151) % BODY AS A WHOLE - GENERAL DISORDERS Back Pain 2 3 2 7 3 Headache 6 9 8 7 5 Influenza-like symptoms 4 2 2 8 5 CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS Dizziness 3 3 2 3 1 GASTROINTESTINAL SYSTEM DISORDERS Dyspepsia 1 3 1 5 3 Mouth dry 4 2 2 2 3 Nausea 4 1 2 4 4 RESPIRATORY SYSTEM DISORDERS Bronchitis 10 11 6 23 19 COPD exacerbation 8 14 13 23 23 Dyspnea 8 8 4 7 4 Sinusitis 1 4 3 11 14 URINARY SYSTEM DISORDER Urinary tract infection 2 3 1 10 8 Cough, rhinitis, and upper respiratory infection occurred in greater than or equal to 3% of patients in either ipratropium treatment group but not greater than placebo in the 12-week study.
In the one open-label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between ipratropium bromide HFA inhalation aerosol and ipratropium bromide CFC inhalation aerosol formulations. 7% of the patients taking 42 mcg ipratropium bromide CFC inhalation aerosol reported at least one adverse event that was considered by the investigator to be related to the study drug.
3% of ipratropium bromide CFC inhalation aerosol patients). As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, halo vision, conjunctival hyperemia, corneal edema, mydriasis, acute eye pain, dry throat, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported with the use of ipratropium bromide HFA inhalation aerosol.
Additional adverse reactions identified for ipratropium bromide HFA inhalation aerosol seen in clinical trials include throat irritation, stomatitis, mouth edema, and vision blurred. 2 )]. 5% in COPD patients receiving ipratropium bromide CFC inhalation aerosol.
In addition to the adverse reactions reported in the controlled clinical trials, adverse reactions have been identified during post-approval use of ipratropium bromide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Allergic-type reactions such as skin rash, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported, with positive rechallenge in some cases.
Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), cough and bronchospasm, including paradoxical bronchospasm, hypersensitivity reactions, intraocular pressure increased, accommodation disorder, heart rate increased, pharyngeal edema, and gastrointestinal motility disorders have been reported during the post-marketing period with use of ipratropium bromide.