SINGULAIR offers an established safety
profile for patients with allergic rhinitis.
SINGULAIR was not associated with sedation in clinical studies, with an incidence similar to placebo
AND
No labeling precautions regarding activities requiring mental alertness
Not a nasal spray, steroid, or antihistamine
No dosage adjustment recommended for patients with renal insufficiency
SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.
In clinical studies, safety profile similar to placebo
In adults and adolescents aged 15 years and older with seasonal or perennial allergic rhinitis, the following adverse events were reported with a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
In pediatric patients aged 2 to 14 years with seasonal allergic rhinitis, the following adverse events occurred with a frequency of >2% and at an incidence greater than placebo, regardless of causality assessment: headache, otitis media, pharyngitis, and upper respiratory infection. The safety profile in patients aged 2 to 14 years with perennial allergic rhinitis is supported by the established safety profile in patients aged 2 to 14 years with seasonal allergic rhinitis.
In pediatric patients aged 6 to 23 months with asthma, the following events occurred with a frequency of >2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: upper respiratory infection, wheezing, otitis media, pharyngitis, tonsillitis, cough, and rhinitis. The safety profile in patients aged 6 to 23 months with perennial allergic rhinitis is supported by data from studies in asthma in this pediatric population and from adult studies.
SINGULAIR is indicated for 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).
Important Information
In clinical trials, SINGULAIR was generally well tolerated, with a safety profile similar to that of placebo. 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.
SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.
Before prescribing SINGULAIR, please read the Prescribing Information.
20753522(1)-09/08-SNG
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