ProAir® HFA Important Safety Information
ProAir® HFA is indicated in adults and children 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. ProAir® HFA, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes. Do not exceed the recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Potential drug interactions can occur with beta blockers, diuretics, digoxin, or monoamine oxidase inhibitor and tricyclic antidepressants.
Adverse events, which occurred at an incidence rate of at least 3% with ProAir® HFA, include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis.
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