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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.