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warnings
WARNINGS 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 PROVENTIL Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids. 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, eg, corticosteroids. Paradoxical Bronchospasm PROVENTIL Inhalation Aerosol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, PROVENTIL Inhalation Aerosol 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. Cardiovascular Effects PROVENTIL Inhalation Aerosol, 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 PROVENTIL Inhalation Aerosol 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, PROVENTIL Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
ADVERSE REACTIONS The adverse reactions of albuterol are similar in nature to those of other sympathomimetic agents, although the incidence of certain cardiovascular effects is less with albuterol. Percent Incidence of Adverse Reactions in Patients ≥ 12 Years of Age in a 13-Week Clinical Trial * (n=147) Adverse Event PROVENTIL Inhalation Aerosol Isoproterenol Inhaler Tremor < 15 < 15 Nausea < 15 < 15 Tachycardia 10 10 Palpitations < 10 < 15 Nervousness < 10 < 15 Increased Blood Pressure < 5 < 5 Dizziness < 5 < 5 Heartburn < 5 < 5 * A 13-week double-blind study compared albuterol and isoproterenol aerosols in 147 asthmatic patients. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, insomnia, headache, unusual taste, and drying or irritation of the oropharynx.