Pediatric Asthma

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Clinical pediatric and adolescent efficacy

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

SELECTED SAFETY INFORMATION

  • Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.
  • In pediatric patients aged 6 to 14 years with asthma, the adverse reactions with an incidence ≥2% and greater than placebo in controlled clinical trials were pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis.

SELECTED SAFETY INFORMATION continued below

Benefits on Singulair

aAsthma exacerbation defined as specific clinically important decreases in PEFR, increase in β-agonist use, increase in daytime or nighttime symptoms, or the occurrence of an asthma attack (defined as an emergency department visit, hospital admission, unscheduled office visit, or need for oral corticosteroid).

bPercentage of days with asthma exacerbation, SINGULAIR 20.6% vs placebo 25.7% reduction in short-acting β-agonist use: SINGULAIR 0.56 puffs per day vs placebo 0.23 puffs per day; global evaluation scores: SINGULAIR 1.34 vs placebo 1.69.

Study Design: An 8-week, double-blind, placebo-controlled trial in 336 children aged 6 to 14 years with a mean baseline predicted FEV1 of 72% (approximate range, 45% to 90%) and a mean daily inhaled β-agonist requirement of 3.4 puffs of albuterol. Approximately 36% of the patients were taking inhaled corticosteroids. The median age was 11 years (range, 6 to 15 years); 35.4% were girls and 64.6% were boys. The ethnic/racial distribution was 80.1% Caucasian, 12.8% Black, 4.5% Hispanic, and 2.7% other origins. The primary end point was FEV1.5,6

Patients had been randomized at the start of the primary study to receive either SINGULAIR or ICSs during the extension; therefore, patients were not rerandomized at the start of the extension.6

SELECTED SAFETY INFORMATION (continued)

  • 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 receiving SINGULAIR should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
  • 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.
  • While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.

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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