Asthma :: Merck’s Singulair approved to prevent exercise-induced bronchoconstriction, asthma

Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR? (montelukast sodium) to prevent exercise-induced bronchoconstriction (EIB; also known as exercise-induced asthma) in patients aged 15 years and older.

SINGULAIR is the first and only oral tablet approved for this use.

EIB is typically characterized by shortness of breath, cough, wheeze and chest tightness brought on by exercise. “EIB affects a broad spectrum of the asthma population. EIB limits the ability to participate in exercise or physical activities.” said David S. Pearlman, M.D., Colorado Allergy and Asthma Centers, P.C. “This indication for SINGULAIR offers physicians a new and effective option to treat appropriate patients with EIB. Asthma is a complex disease, and a variety of treatment options are needed to manage different patients.”

In clinical studies, a single tablet of SINGULAIR 10 mg prevented EIB when taken two hours before exercise. Some patients were protected from EIB at 8.5 and 24 hours after administration; however, some patients were not. SINGULAIR should not be taken for the immediate relief of asthma attacks. Patients should always have their inhaled rescue medicine available.

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. Patients already taking one tablet daily for another indication, including chronic asthma, should not take an additional dose to prevent EIB. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.


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