Singulair Oral Granules

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Prescribing Information Patient Information Return to singulair.com

Dosage

SINGULAIR—Multiple formulations for patients aged 6 months and older

SINGULAIR offers convenient once-daily oral formulations:

  • Can be taken without regard to the timing of meals
  • No dosage adjustment recommended for patients with renal insufficiency

Flexible once-daily AM or PM dosing

Try SINGULAIR for your next appropriate patient with symptoms of allergic rhinitis

Oral Granules Dose for children aged 6 months to 5 years

Pediatric patients aged 6 months to 5 years with perennial allergic rhinitis AND pediatric patients aged 2 to 5 years with seasonal allergic rhinitis—one 4-mg oral granules packet daily
How to administer oral
granules

4 mg cherry chewable tablet for children aged 2 to 5 years

Pediatric patients aged 2 to 5 years with perennial or seasonal allergic rhinitis—one 4-mg cherry chewable tablet daily

5 mg cherry chewable tablet for children aged 6 to 14 years

Pediatric patients aged 6 to 14 years—one 5-mg cherry chewable tablet daily

10 mg tablets for adults and adolescents aged 15 years and older

Adults and adolescents aged 15 years and older—one 10-mg tablet daily

Tablets and oral granules packet shown not actual size.

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).

SELECTED SAFETY INFORMATION

  • 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.
  • 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.
  • SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.
  • Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine, a component of aspartame.

Before prescribing SINGULAIR, please read the Prescribing Information.

20951837(3)-02/10-SNG

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