SINGULAIR is indicated for relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

SELECTED SAFETY INFORMATION

• For allergic rhinitis, SINGULAIR should be taken once daily. The time of administration may be individualized to suit patient needs.
• 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.
• 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.
• 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 in pediatric patients younger than 2 years with seasonal allergic rhinitis have not been established.
• Safety and effectiveness in pediatric patients younger than 6 months with perennial allergic rhinitis have not been established.
• Other AE balance for each age group:
  In patients aged 15 years and older with seasonal allergic rhinitis, the adverse reaction with an incidence ≥1% and greater than placebo in controlled clinical trials was upper respiratory infection.
  In pediatric patients aged 2 to 14 years with seasonal allergic rhinitis, the adverse reactions with an incidence ≥2% and greater than placebo in controlled clinical trials were headache, otitis media, pharyngitis, and upper respiratory infection.
  In patients aged 15 years and older with perennial allergic rhinitis, the adverse reactions with an incidence ≥1% and greater than placebo in controlled clinical trials were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
  The safety in patients aged 2 to 14 years with perennial allergic rhinitis is supported by the safety in patients aged 2 to 14 years with seasonal allergic rhinitis. The safety in patients aged 6 to 23 months is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies.

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