Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Hypersensitivity Reactions, Including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] • Paradoxical Bronchospasm [see Warnings and Precautions ( 5.3 )] • Ocular Effects [see Warnings and Precautions ( 5.4 )] • Urinary Retention [see Warnings and Precautions ( 5.5 )] 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.
Most common adverse reactions (>5% incidence in the 12-week placebo- controlled trials) were bronchitis, COPD exacerbation, dyspnea, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Armstrong Pharmaceuticals, Inc.
at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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.
TABLE 1 Adverse Reactions (% Patients) in Ipratropium Bromide HFA Inhalation Aerosol Clinical Trials Placebo-controlled 12-week study 244.1405 and Active-controlled 12-week Study 244.1408 Active-controlled 1-year Study 244.2453 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.
Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ipratropium bromide HFA inhalation aerosol and 8.7% 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.
5 WARNINGS AND PRECAUTIONS • Not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response ( 5.1 ) • Hypersensitivity reactions including anaphylaxis: Discontinue ipratropium bromide HFA inhalation aerosol at once and consider alternative treatments ( 5.2 ) • Paradoxical bronchospasm: Discontinue ipratropium bromide HFA inhalation aerosol and consider other treatments if paradoxical bronchospasm occurs ( 5.3 ) • Ocular effects: Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if signs or symptoms of narrow-angle glaucoma develop ( 5.4 ) • Urinary retention: Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if signs or symptoms of urinary retention develop ( 5.5 ) 5.1 Use for Maintenance Treatment Only Ipratropium bromide HFA inhalation aerosol is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.
5.2 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after the administration of ipratropium bromide HFA inhalation aerosol.
In clinical trials and postmarketing experience with ipratropium-containing products, hypersensitivity reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported [see Adverse Reactions ( 6.1 , 6.2 )].
If such a reaction occurs, therapy with ipratropium bromide HFA inhalation aerosol should be stopped at once and alternative treatment should be considered [see Contraindications ( 4 )].
5.3 Paradoxical Bronchospasm Ipratropium bromide HFA inhalation aerosol can produce paradoxical bronchospasm that can be life threatening.
Like all medications, Ipratropium Bromide Inhalation can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: