Safety and effectiveness in the pediatric population below the age of 12 have not been established.
Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature.
All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.
Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis and acute eye pain have been reported.
Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg.
Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.
|All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials.|
|PERCENT OF PATIENTS|
|Ipratropium||Metaproterenol||Ipratropium/ Metaproterenol||Albuterol||Ipratropium/ Albuterol|
|(500 mcg t.i.d.)||(15 mg t.i.d.)||(500 mcg t.i.d./ 15 mg t.i.d.)||(2.5 mg t.i.d.)||(500 mcg t.i.d./ 2.5 mg t.i.d.)|
|n = 219||n = 212||n = 108||n = 205||n = 100|
|Body as a Whole-General Disorders|
|Central & Peripheral Nervous System|
|Gastrointestinal System Disorders|
|Musculo -skeletal System Disorders|
|Respiratory System Disorders (Lower)|
|Respiratory System Disorders (Upper)|
|Upper Respiratory Tract Infection||13.2||11.3||9.3||12.2||16.0|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.