Resources Available to Help Take Control
WILMINGTON, Del., Nov. 11, 2013 /PRNewswire/ -- For many Americans, breathing is a challenge. Over 12 million have chronic obstructive pulmonary disease (COPD) and live with symptoms, including constant coughing, wheezing, and shortness of breath. But with an additional 12 million Americans remaining undiagnosed, recognizing COPD signs and symptoms and seeking help is an important health priority.
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"November is National COPD Awareness Month, so it's a good time to talk about the need to educate and encourage patients to take control of their COPD symptoms," said Frank Trudo, MD, Medical Affairs, AstraZeneca. "Since many are not even aware that they have COPD, it is important for them to check in with their doctors about their symptoms to ensure proper diagnosis and discuss available treatment options."
COPD is a serious lung disease that is the third leading cause of death in the US. COPD can start early, sometimes occurring in people as young as 40 years old with a history of smoking, and it is a progressive disease in which signs and symptoms worsen over time.
As part of AstraZeneca's commitment to respiratory disease education, during National COPD Awareness Month (NYSE: AZN), the company is making resources available to aid patients in disease management.
Although there is no cure for COPD, there are FDA-approved treatments, including SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol. SYMBICORT, a combination of inhaled corticosteroid and long-acting beta2-adrenergic agonist made by AstraZeneca, is indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. For more information please visit www.symbicorttouchpoints.com/copd.
Please see full Prescribing Information, including Boxed WARNING.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
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.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids.
Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.
Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
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 convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.
Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.
In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.
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. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.
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.
WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.
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.
SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
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.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
SYMBICORT is a registered trademark, and AZ&Me is a trademark, of the AstraZeneca group of companies.
©2013 AstraZeneca. All rights reserved.
2925100 Last Updated 11/13