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FDA Updates U.S. Product Labels for LABA-Containing Medications Including AstraZeneca's SYMBICORT
Date:6/2/2010

f SYMBICORT.

SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents.

Additional Information Specific to Asthma

The most common adverse events greater than or equal to 5% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Additional Information Specific to COPD

For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily.

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.

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.

Indications

SYMBICORT is indicated for the treatment of asthma in patients 12 years of age and older.

SYMBICORT 160/4.5 mcg is also 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 two inhalations twice daily. SYMBICORT does not replace fast
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SOURCE AstraZeneca
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