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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.

5.18 Hypokalemia and Hyperglycemia. 6 ADVERSE REACTIONS. 6.1 Clinical Trials Experience in Asthma 6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease. 6.3 Postmarketing Experience. 7 DRUG INTERACTIONS. Antidepressants 7.3 Beta-Adrenergic Receptor Blocking Agents 7.4 Diuretics. 8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy …

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