Safety Profile

Indications and Important Safety Information, including boxed WARNING

• 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 emphysema
• For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily
• Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids
• In 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not occur with greater incidence in the SYMBICORT 160/4.5 group, compared with placebo, while the incidence of lung infections other than pneumonia (eg, bronchitis) was higher for SYMBICORT than placebo
• SYMBICORT is not a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
• Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral density
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including budesonide, a component of SYMBICORT
• Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting beta₂-agonists for any reason
• Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known potent CYP3A4 inhibitors
• SYMBICORT should be administered with caution in patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
• Particular care is needed for patients being transferred from systemically active corticosteroids to inhaled corticosteroids
• SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD and/or used to treat acute symptoms
• Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Some patients may experience an increase in blood pressure or heart rate
• The most common adverse events ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
• 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)

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.

  This product information is intended for US health care professionals only.

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