FDA label 20eb8abb-b53f-4495-8ae9-c4bdb01bd7ce

WARNINGS Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.

ADVERSE REACTIONS Adverse reaction information on Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) 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% (Nasal Spray), 352 patients on Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray), 189 patients on Ipratropium Bromide Nasal Spray 0.12%, 351 patients on vehicle and 189 patients receiving no treatment). The following table shows adverse events reported for patients who received Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) 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% (Nasal Spray) group and higher in the Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) group than in the vehicle group. % of Patients Reporting Events This table includes adverse events for which the incidence was 1% or greater in the Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) group and higher in the Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) group than in the vehicle group. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) (N=352) Vehicle Control (N=351) Epistaxis Epistaxis reported by 5.4% of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) patients and 1.4% of vehicle patients, blood tinged nasal mucus by 2.8% of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) patients and 0.9% of vehicle patients. 8.2% 2.3% Nasal Dryness 4.8% 2.8% Dry Mouth/Throat 1.4% 0.3% Nasal Congestion 1.1% 0.0% Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) 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% (Nasal Spray) 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% (Nasal Spray) during the controlled clinical trials that are potentially related to Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) 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. Additional anticholinergic effects noted with other ipratropium bromide dosage forms (Ipratropium Bromide Inhalation Solution, Ipratropium Bromide Inhalation Aerosol and Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray)) include: precipitation or worsening of narrow-angle glaucoma, urinary retention, prostate disorders, constipation and bowel obstruction. There were no reports of allergic-type reactions in the controlled clinical trials. Allergic-type reactions such as skin rash, angioedema of the tongue, lips and face, urticaria, laryngospasm and anaphylactic reactions have been reported with other ipratropium bromide products.

<table> <col width="19%"/> <col width="38%"/> <col width="10%"/> <thead> <tr> <th styleCode="Lrule Toprule "/> <th colspan="2" styleCode="Rrule Toprule "> <content styleCode="bold">% of Patients Reporting Events</content> <footnote ID="_RefID0EQMAC">This table includes adverse events for which the incidence was 1% or greater in the Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) group and higher in the Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) group than in the vehicle group.</footnote> </th> </tr> <tr> <th styleCode="Lrule Botrule "/> <th styleCode="Botrule "> <content styleCode="bold">Ipratropium Bromide</content> <content styleCode="bold">Nasal Solution 0.06% (Nasal Spray)</content> <content styleCode="bold">(N=352)</content> </th> <th styleCode="Rrule Botrule "> <content styleCode="bold">Vehicle</content> <content styleCode="bold">Control </content> <content styleCode="bold">(N=351)</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Toprule " valign="top"> <paragraph>Epistaxis<footnote ID="_RefID0EGNAC">Epistaxis reported by 5.4% of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) patients and 1.4% of vehicle patients, blood tinged nasal mucus by 2.8% of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) patients and 0.9% of vehicle patients.</footnote> </paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph>8.2%</paragraph> </td> <td styleCode="Rrule Toprule " valign="top"> <paragraph>2.3%</paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <paragraph>Nasal Dryness</paragraph> </td> <td valign="top"> <paragraph>4.8%</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph>2.8%</paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <paragraph>Dry Mouth/Throat</paragraph> </td> <td valign="top"> <paragraph>1.4%</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph>0.3%</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule " valign="top"> <paragraph>Nasal Congestion</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>1.1%</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>0.0%</paragraph> </td> </tr> </tbody> </table>