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warnings
WARNINGS: Paradoxical Bronchospasm: Albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate inhalation solution 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 or vial. Albuterol sulfate inhalation solution contains the preservative benzalkonium chloride. Benzalkonium chloride has been associated with bronchospasm in a dose-dependent manner. In patients who receive high doses (e.g. continuous nebulization) of albuterol sulfate inhalation solution and bronchospasm does not resolve, consider a trial of short-acting bronchodilator that does not contain the preservative benzalkonium chloride (see DOSAGE AND ADMINISTRATION ) . Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse. Cardiovascular Effects: Albuterol sulfate inhalation solution, like all 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 albuterol sulfate inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QT C interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol sulfate inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol sulfate inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Use of Anti-inflammatory Agents: The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. Microbial Contamination: To avoid microbial contamination, proper aseptic technique should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
ADVERSE REACTIONS: The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects that were considered probably or possibly drug related: Percent Incidence of Adverse Reactions Reaction Percent Incidence n=135 Central Nervous System Tremors 20% Dizziness 7% Nervousness 4% Headache 3% Sleeplessness 1% Gastrointestinal Nausea 4% Dyspepsia 1% Ear, nose and throat Nasal congestion 1% Pharyngitis <1% Cardiovascular Tachycardia 1% Hypertension 1% Respiratory Bronchospasm 8% Cough 4% Bronchitis 4% Wheezing 1% No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventicular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.