Efficacy
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.
- 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.
SELECTED SAFETY INFORMATION continued below
Clinical pediatric and adolescent efficacy
In a clinical study, important measures of asthma control were significantly improved in pediatric patients taking SINGULAIR.5–7
SELECTED SAFETY INFORMATION (continued)
- 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.
- Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal antiinflammatory agents while taking SINGULAIR.
- Parents or guardians of patients with phenylketonuria should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine, a component of aspartame.
Please see Selected Safety Information about SINGULAIR.
Before prescribing SINGULAIR, please read the Prescribing Information.
RESP-1007091-0003 01/12