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adverse reactions
ADVERSE REACTIONS Adverse reaction information on Ipratropium Bromide Nasal Solution 0.06% in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on Ipratropium Bromide Nasal Solution 0.03%, 352 patients on Ipratropium Bromide Nasal Spray 0.06%, 189 patients on Ipratropium Bromide Nasal Solution 0.12%, 351 patients on vehicle and 189 patients receiving no treatment). Table 1 shows adverse events reported for patients who received Ipratropium Bromide Nasal Solution 0.06% at the recommended dose of 84 mcg per nostril, or vehicle, administered three or four times daily, where the incidence is 1% or greater in the Ipratropium Bromide Nasal Solution 0.06% group and higher in the Ipratropium Bromide Nasal Solution0.06% group than in the vehicle group. Table 1 % of Patients with Common Cold Reporting Events 1 Ipratropium Bromide Nasal Solution 0.06% Vehicle Control No. of Patients 352 351 Epistaxis 2 8.2% 2.3% Nasal Dryness 4.8% 2.8% Dry Mouth/Throat 1.4% 0.3% Nasal Congestion 1.1% 0.0% 1 This table includes adverse events for which the incidence was 1% or greater in the Ipratropium Bromide NasalSolution0.06% group and higher in the Ipratropium Bromide NasalSolution0.06% group than in the vehicle group. 2 Epistaxis reported by 5.4% of Ipratropium Bromide NasalSolution0.06% patients and 1.4% of vehicle patients, blood tinged nasal mucus by 2.8% of Ipratropium Bromide NasalSolution0.06% patients and 0.9% of vehicle patients. Ipratropium Bromide Nasal Solution 0.06% was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none was considered serious, and none resulted in hospitalization. No patient required treatment for nasal dryness, and only three patients (<1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving Ipratropium Bromide Nasal Solution 0.06% was discontinued from the trial due to either nasal dryness or bleeding. Adverse events reported by less than 1% of the patients receiving Ipratropium Bromide Nasal Solution 0.06% during the controlled clinical trials that are potentially related to Ipratropium Bromide Nasal Solution 0.06% local effects or systemic anticholinergic effects include: taste perversion, nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation, pharyngitis, tachycardia, thirst, tinnitus, and blurred vision. No controlled trial was conducted to address the relative incidence of adverse events for three times daily versus four times daily therapy. Nasal adverse events seen in the clinical trial with seasonal allergic rhinitis (SAR) patients (see Table 2) were similar to those seen in the common cold trials. Additional events were reported at a higher rate in the SAR trial due in part to the longer duration of the trial and the inclusion of upper respiratory tract infection (URI) as an adverse event. In common cold trials, URI was the disease under study and not an adverse event. Table 2 % of Patients with SAR Reporting Events 1 Ipratropium Bromide Nasal Solution 0.06% Vehicle Control No. of Patients 218 211 Epistaxis 2 6.0% 3.3% Pharyngitis 5.0% 3.8% URI 5.0% 3.3% Nasal Dryness 4.6% 0.9% Headache 4.1% 0.5% Dry Mouth/Throat 4.1% 0.0% Taste Perversion 3.7% 1.4% Sinusitis 2.8% 2.8% Pain 1.8% 0.9% Diarrhea 1.8% 0.5% 1 This table includes adverse events for which the incidence was 1% or greater in the Ipratropium Bromide NasalSolution0.06% group and higher in the Ipratropium Bromide NasalSolution0.06% group than in the vehicle group. 2 Epistaxis reported by 3.7% of Ipratropium Bromide NasalSolution0.06% patients and 2.4% of vehicle patients, blood tinged nasal mucus by 2.3% of Ipratropium Bromide NasalSolution0.06% patients and 1.9% of vehicle patients. There were no reports of allergic-type reactions in the controlled clinical common cold and SAR trials. Post-Marketing Experience Allergic-type reactions such as skin rash, angioedema, including that of the throat, tongue, lips and face, generalized urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported with Ipratropium Bromide Nasal Solution 0.06% and for other ipratropium bromide-containing products, with positive rechallenge in some cases. Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: urinary retention, prostatic disorders, mydriasis, cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, ocular irritation, wheezing, dryness of the oropharynx, tachycardia, edema, gastrointestinal distress (diarrhea, nausea, vomiting), bowel obstruction, constipation, nasal discomfort, throat irritation, hypersensitivity, accommodation disorder, intraocular pressure increased, glaucoma, halo vision, conjunctival hyperaemia, corneal edema, heart rate increased, bronchospasm, pharyngeal edema, gastrointestinal motility disorder, mouth edema, stomatitis, and pruritus. After oral inhalation of ipratropium bromide in patients suffering from COPD/Asthma supraventricular tachycardia and atrial fibrillation have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.