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.
ADVERSE REACTIONS: Adverse reaction information on Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on ipratropium bromide and 347 patients on vehicle), and a one-year, open-label, follow-up trial.
In three of the trials, patients received Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) three times daily, for eight weeks.
In the other trial, Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) was given to patients two times daily for four weeks.
Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year.
The majority (>86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray).
Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks.
Only adverse events reported with an incidence of at least 2.0% in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group are shown.
Table 1 % of Patients Reporting Events* Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) (n=356) Incidence% Discontinued% Headache 9.8 0.6 Upper respiratory tract infection 9.8 1.4 Epistaxis † 9.0 0.3 Rhinitis ‡ Nasal dryness 5.1 0.0 Nasal irritation § 2.0 0.0 Other nasal symptoms ¶ 3.1 1.1 Pharyngitis 8.1 0.3 Nausea 2.2 0.3 Vehicle Control (n=347) Incidence% Discontinued% Headache 9.2 0.0 Upper respiratory tract infection 7.2 1.4 Epistaxis † 4.6 0.3 Rhinitis ‡ Nasal dryness 0.9 0.3 Nasal irritation § 1.7 0.6 Other nasal symptoms ¶ 1.7 0.3 Pharyngitis 4.6 0.0 Nausea 0.9 0.0 * This table includes adverse events which occurred at an incidence rate of at least 2.0% in the ipratropium bromide group and more frequently in the ipratropium bromide group than in the vehicle group.
† Epistaxis reported by 7.0% of ipratropium bromide patients and 2.3% of vehicle patients, blood-tinged mucus by 2.0% of ipratropium bromide patients and 2.3% of vehicle patients.
§ Nasal irritation includes reports of nasal itching, nasal burning, nasal irritation, and ulcerative rhinitis.
WARNINGS: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
If such a reaction occurs, therapy with Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) should be stopped at once and alternative treatment should be considered.
Like all medications, Ipratroprium Bromide 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: