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SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.
SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.
For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose.
Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist.
Chronic daily administration of SINGULAIR for other indications has not been established to prevent acute episodes of EIB.
Patients with known aspirin sensitivity should continue avoidance of aspirin or nonsteroidal antiinflammatory agents while taking SINGULAIR.
Safety and effectiveness of SINGULAIR for EIB in patients younger than 15 years have not been established.
The safety profile in patients with EIB was generally similar to the safety profile in adults with asthma. In clinical studies of asthma, adverse events were generally mild and varied by age. The most common adverse events in adults and adolescents aged 15 years and older were headache, influenza, abdominal pain, cough, and dyspepsia.
Prescribing Information and Patient Product Information
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