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

For prevention of EIB, a single 10-mg 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 SINGULAIR daily for another indication should not take an additional dose to prevent EIB.

Daily administration of SINGULAIR for other indications has not been established to prevent acute episodes of EIB.

SELECTED SAFETY INFORMATION

SINGULAIR should not be used as rescue medication to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.

Neuropsychiatric events have been reported in patients taking SINGULAIR. These events included agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some postmarketing reports appear consistent with a drug-induced effect. Patients should be advised to report any neuropsychiatric events.

Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal antiinflammatory agents while taking SINGULAIR.

SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.

The most common adverse reactions with an incidence >5% and greater than placebo in controlled clinical trials were upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, and otitis.

Safety and effectiveness of SINGULAIR for EIB in patients younger than 15 years have not been established.

Before prescribing SINGULAIR, please read the Prescribing Information. The Patient Information also is available.