Ipratropium Bromide (Page 2 of 3)

Pediatric Use

Safety and effectiveness in the pediatric population below the age of 12 have not been established.

ADVERSE REACTIONS

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, from a Double-blind, Parallel, 12-week Study of patients with COPD*
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
Headache 6.4 5.2 6.5 6.3 9.0
Pain 4.1 3.3 0.9 2.9 5.0
Influenza-like symptoms 3.7 4.7 6.5 0.5 1.0
Back Pain 3.2 1.9 1.9 2.4 0.0
Chest Pain 3.2 4.2 5.6 2.0 1.0
Cardiovascular Disorders
Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5 4.0
Central & Peripheral Nervous System
Dizziness 2.3 3.3 1.9 3.9 4.0
Insomnia 0.9 0.5 4.6 1.0 1.0
Tremor 0.9 7.1 8.3 1.0 0.0
Nervousness 0.5 4.7 6.5 1.0 1.0
Gastrointestinal System Disorders
Mouth Dryness 3.2 0.0 1.9 2.0 3.0
Nausea 4.1 3.8 1.9 2.9 2.0
Constipation 0.9 0.0 3.7 1.0 1.0
Musculo -skeletal System Disorders
Arthritis 0.9 1.4 0.9 0.5 3.0
Respiratory System Disorders (Lower)
Coughing 4.6 8.0 6.5 5.4 6.0
Dyspnea 9.6 13.2 16.7 12.7 9.0
Bronchitis 14.6 24.5 15.7 16.6 20.0
Bronchospasm 2.3 2.8 4.6 5.4 5.0
Sputum Increased 1.4 1.4 4.6 3.4 0.0
Respiratory Disorder 0.0 6.1 6.5 2.0 4.0
Respiratory System Disorders (Upper)
Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2 16.0
Pharyngitis 3.7 4.2 5.6 2.9 4.0
Rhinitis 2.3 4.2 1.9 2.4 0.0
Sinusitus 2.3 2.8 0.9 5.4 4.0

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