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.
Please see full Prescribing Information and visit http://www.MySYMBICORT.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services. AstraZe
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