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news.The FDA has approved a new indication for Merck & Co.'s Singulair to prevent exercise-induced bronchoconstriction in patients aged 15 years and older, making it the only oral tablet approved for this use.
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Exercise-induced bronchoconstriction (EIB) is typically characterized by shortness of breath, cough, wheeze and chest tightness brought on by exercise.
In clinical studies, a single tablet of Singulair 10mg prevented EIB when taken two hours before exercise. Some patients were protected from EIB at 8.5 and 24 hours after administration, although some were not.
In addition to now being approved for use prior to exercise in appropriate patients with EIB, Singulair continues to be an option for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.