WARNINGS 1. Paradoxical Bronchospasm: Combivent Inhalation Aerosol can produce paradoxical bronchospasm that can be life threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. 2. Cardiovascular Effect: The albuterol sulfate contained in Combivent Inhalation Aerosol, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/ or symptoms. Although such effects are uncommon after administration of Combivent Inhalation Aerosol at recommended doses, if they occur, discontinuation of the drug may be indicated. In addition, beta-adrenergic agents have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, Combivent Inhalation Aerosol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension. 3. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. 4. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide or albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, ronchospasm, anaphylaxis and oropharyngeal edema. | ||||
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