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

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.

While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.

Patients receiving SINGULAIR should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.

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.

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

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

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