SINGULAIR Patient Information

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Patient Information

SINGULAIR®
(MONTELUKAST SODIUM)

TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES

View the Patient Information for SINGULAIR (English/Ingles)

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

  • 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.
  • 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.

Before prescribing SINGULAIR, please read the Prescribing Information.

20951837(5)-07/10-SNG

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