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Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI
Date:10/29/2008

obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist(TM) Inhalation Solution belongs to a class of medications known as long-acting beta2-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (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 LABA), the active ingredient in Perforomist(TM) Inhalation Solution.

Perforomist(TM) Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist(TM) Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist(TM) Inhalation Solution in asthma has not been established. Perforomist(TM) Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist(TM) Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.

In COPD clinical trials, the most common adverse events reported with Perforomist(TM) Inhalation Solution (>2% and more common than placebo) were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning, at http://www.perforomist.com or call 800-755-5560 and ask for Customer Service.

About Dey, L.P.

Dey, L.P., a subsidiary of Mylan Inc. (NYSE: '/>"/>

SOURCE Dey, L.P.
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