Important Information

SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months 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.

Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.

Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.

Patients should be advised to take SINGULAIR daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled.

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.

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  |  Patient Product Information

This site is intended only for health care professionals of the United States, its territories, and Puerto Rico. SINGULAIR, Merck OnCall^®, and MerckServices are registered trademarks of Merck & Co., Inc. MerckProductServices is a trademark of Merck & Co., Inc.

For general information and other services for physicians