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Dey, L.P. Highlights Perforomist(R) Inhalation Solution Data to Be Presented at the International Conference of the American Thoracic Society
Date:5/14/2009

zed treatment may be right for them.

About Perforomist(R) Inhalation Solution

Perforomist Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist(R) (formoterol fumarate) 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 U.S. 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 Inhalation Solution.

Perforomist 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 Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist Inhalation Solution in asthma has not been established. Perforomist Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist 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 Inhalation Solution (>2% and more common than placebo) were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

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SOURCE Dey, L.P.
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