Budesonide and Formoterol Fumarate Dihydrate

1 INDICATIONS AND USAGE SYMBICORT is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: • SYMBICORT is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: • SYMBICORT is NOT indicated for the relief of acute bronchospasm.