Adverse reaction information concerning Combivent Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for Combivent Inhalation Aerosol).

All Adverse Events (in percentages), from Two Large Double-Blind, Parallel, 12-Week Studies of Patients with COPD*

Additional adverse reactions, reported in less than two percent of the patients in the Combivent Inhalation Aerosol treatment group include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, and urinary tract infection/dysuria.

Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported, with positive rechallenge in some cases. Many of these patients had a history of allergies to other drugs and/or foods including soybean (see CONTRAINDICATIONS).

Additional information derived from the published literature and post-marketing surveillance on the use of ipratropium or albuterol inhalation aerosol singly or in combination that is not included in the lists above includes: cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, nasal congestion, drying of secretions, mucosal ulcers, irritation from aerosol, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, heartburn, drowsiness, CNS stimulation, coordination difficulty, weakness, itching, flushing, alopecia, hypotension, gastrointestinal distress, constipation, and urinary difficulties.

Combivent Inhalation Aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD, without adverse drug reactions. No formal drug interaction studies have been performed with Combivent Inhalation Aerosol and these or other medications commonly used in the treatment of COPD.

Anticholinergic agents: Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of Combivent Inhalation Aerosol with other anticholinergic-containing drugs.

Beta-adrenergic agents: Caution is advised in the co-administration of Combivent Inhalation Aerosol and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.

Beta-receptor blocking agents and albuterol inhibit the effect of each other. Beta-receptor blocking agents should be used with caution in patients with hyperreactive airways.

Diuretics: The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta- agonist-containing drugs, such as Combivent Inhalation Aerosol, with non-potassium sparing diuretics.

Monoamine oxidase inhibitors or tricyclic antidepressants: Combivent Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within two weeks of discontinuation of such agents because the action of albuterol on the cardiovascular system may be potentiated.

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