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FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
Date:2/27/2009

onia (e.g., bronchitis) was higher for SYMBICORT than placebo.

SYMBICORT is not a rescue medication and does not replace fast-acting inhalers to treat acute symptoms.

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

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

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 greater than or equal to 3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis and upper respiratory tract infection.

Common adverse events reported in asthma clinical trials, occurring in greater than or equal to 5% of patients, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Particular care is needed for patients being transferred from systemically active corticosteroids to inhaled corticosteroids.

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 two maintenance therapies. Data from a large placebo-controlled US'/>"/>

SOURCE AstraZeneca
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