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SYMBICORT Prescribing Information

HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use SYMBICORT safely and effectively. See full Prescribing Information for (budesonide and formoterol fumarate dihydrate)Inhalation Aerosol, for oral inhalation useInitial Approval: 2006------------------------------------ ---- INDICATIONS AND USAGE ---------------------------------------- SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: Treatment of asthma in patients 6 years of age and older. ( ) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( )Important limitations: Not indicated for the relief of acute bronchospasm. ( , )------------------------------------ DOSAGE AND ADMINISTRATION ------------------------------------For oral inhalation only.

• Glaucoma and cataracts: Close monitoring is warranted. (5.15) • Metabolic effects: Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.16, 5.18) • Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.17)

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