MAXAIR™ AUTOHAIiR™(pirbuterol acetate inhalation aerosol) Bronchodilator Aerosol For Inhalation Only BRIEF SUMMARY INDICAT10NS AND USAGE: MAXAIR AUTOHALER is indicated ior the prevention and reversal of bronchospasm in patients wilh reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or Steroid therapy. CONTRAINDICATIONS: MAXAIR is contraindicated in patients with a history of hypersensitivity to any of its ingredients. WARNINGS: As with other beta adrenergic aerosols, MAXAIR should not be used in excess. Controlled clinical studies and other clinical experience have shown that MAXAIR like other inhaled beta adrenergic agonists can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, Symptoms, and/or EC6 changes. As with other beta adrenergic aerosols, the potential for paradoxical bronchospasm (which can be life threatening) should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.Fatalities have been reported in association with excessive use of inhaled sympattiomimetic drugs. The contents of MAXAIR AUTOHALER are under pressure. Do not puncture. Do not use or störe near heat or open flame. Exposure to temperature above 120'F may cause bursting. Never throw Container into fire or incinerator. Keep out of reachotchildren. PRECAUTIONS: General -Since pirbuterol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, or cardiac arrhythmias. in patients with hyperttiyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients alter use of any beta adrenergic aerosol bronchodilator. Information for Patients -MAXAIR effects may last up to five hours or longer. It should not be used more often than recommended and the patient should not increase the number of inhalations or frequency of use without lirst asking the physician. If spptorns of asthma get worse, adverse reactions occur, or the patient does not respond to the usual dose, the patient should be instructed to contact the physician immediately. The patient should be advised to see the lllustrated Patient's Instructions for Use.The Autohaler actuator should not be used with any other inhalation aerosol canister. In addition, canisters Ior use with MAXAIR AUTOHALER should not be utilized with any other actuator. Drug Interactions -Other beta adrenergic aerosol bronchodilators should not be used concomitantly with MAXAIR because they may have additive effects. Beta adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular System may be potentiated. Carcinogenesis, Mutagenes^ and Impai...