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IMPORTANT PRODUCT INFORMATION
SINGULAIR is indicated for
Prophylaxis and chronic treatment of asthma in patients aged 12 months and older.
Prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.
Relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and children aged 2 years and older and perennial allergic
rhinitis in adults and children aged 6 months and older).
SELECTED SAFETY INFORMATION
SINGULAIR should not be used as rescue medication to treat acute asthma episodes. 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, 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.
Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.
In clinical trials in patients with allergic rhinitis, adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis, and increased ALT.
Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB.
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.
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