Study Compares Bronchodilatory Effects of SYMBICORT(R) and Advair in Adults W... (not replace fast-acting inhalers andshou...)

Study Compares Bronchodilatory Effects of SYMBICORT(R) and Advair in Adults With Asthma

Date:3/18/2008

not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma. SYMBICORT has safety data in long-term studies of up to one year, and has a robust cardiac safety profile.

Important Safety Information

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 not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study 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.

SYMBICORT is not indicated for the relief of acute bronchospasm.

SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.

Common adverse events reported in clinical trials, occurring in greater than or equal to 5 percent of patients, regardless of relationship to treatment, including nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

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