Indications and Important Safety Information, including boxed warning

• SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years and older
• SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma
• SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta₂-agonists
  
  WARNING: Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma-controller medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta₂-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)
• SYMBICORT 160/4.5 mcg, 2 inhalations twice daily is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
• SYMBICORT is not a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
• SYMBICORT is NOT indicated for the relief of acute bronchospasm

Please see full Prescribing Information, including boxed WARNING.