Allergy Season

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Prescribing Information Patient Information Selected Safety Information Return to singulair.com

For chronic asthma during allergy season

SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older.

SELECTED SAFETY INFORMATION

  • SINGULAIR should not be used as rescue medication to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
  • 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.

SELECTED SAFETY INFORMATION continued below

In a clinical study involving patients aged >18 years with chronic asthma and allergen sensitivity
SINGULAIR significantly improved asthma symptom control during allergy season4

Study patient population:

  • History of chronic asthma also active during allergy season
  • Skin-test sensitivity to at least 2 seasonal triggers
24% Reduction
21% Reduction
Increase in AM PEFR
Discontinuations due to Asthma

a Adapted from Busse WW, Casale TB, Dykewicz MS, et al. Annals of Allergy, Asthma & Immunology. 2006;96;60–68. Copyright © 2006, American College of Allergy, Asthma & Immunology. All rights reserved.

SINGULAIR also provided:

  • Significant reduction in nighttime asthma symptoms (P<0.001) when compared with placebo
  • Significant improvement in mean change from baseline in pm PEFR (11.3 L/min) when compared with placebo
    (–2.0 L/min) (P<0.001)
  • No significant difference in the percentage of asthma attacksb (2.2%) when compared with placebo (1.7%) (P=NS)

b Asthma attack was defined as any of the following:

  • Emergency department visit
  • Hospital admission
  • Unscheduled office visit
  • Need for oral, intravenous, or intramuscular corticosteroid

Study Design: A 4-week, multicenter, randomized, placebo-controlled, parallel-group study of 455 men and women with chronic asthma for at least 1 year, which was also active during the allergy season. Study participants were aged ≥18 years and had FEV1 60% or greater of predicted value. The average ethnic/racial distribution in this study was 81.3% Caucasian, 10.4% Black, 6% Hispanic, and 2.4% other origins. Seventy percent of the patients were female. The study took place during spring allergy season and consisted of a 1-week, single-blind, placebo run-in period followed by a 3-week, double-blind, efficacy and safety evaluation period. Patients were randomized to receive SINGULAIR 10 mg or placebo once daily at bedtime. The primary end point was daytime asthma symptom score.4

SELECTED SAFETY INFORMATION (continued)

  • Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal antiinflammatory agents while taking SINGULAIR.
  • Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy.
  • SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.

Please see Selected Safety Information about SINGULAIR.

Before prescribing SINGULAIR, please read the Prescribing Information.

See all references.

RESP-1007091-0003 01/12

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