Singulair Oral Granules

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Prescribing Information Patient Information Return to singulair.com

Dosage

SINGULAIR—Multiple formulations for patients 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

In clinical studies, SINGULAIR was not associated with sedation, with an incidence similar to placebo.

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

SINGULAIR: 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

SINGULAIR: 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

SINGULAIR: 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

SINGULAIR: 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

Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine, a component of aspartame. 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).

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.

20950124(1)-01/09-SNG

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