WEDNESDAY, April 25, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved the Merck asthma and allergy drug Singulair (montelukast sodium) for people aged 15 and older who experience asthma symptoms during exercise, the company said Wednesday.
Symptoms of the condition, medically known as exercise-induced bronchoconstriction, include shortness of breath, coughing, wheezing and chest tightness.
In clinical testing involving 160 people, those who took a 10-milligram dose of Singulair two hours before exercise showed a significant reduction in symptoms compared with those who took a placebo, Merck said in a statement.
People who already take Singulair daily for other reasons, including chronic asthma, should never take an additional dose before exercise, the company warned.
Side effects reported during clinical testing included headache, ear infection, sore throat and upper respiratory infection.
Singulair is already approved to treat asthma in people 1 year and older, and for seasonal allergy symptoms in adults and children 2 years and older.
The FDA has more about Singulair's labeling and approval history.