Singulair

Most frequently reported adverse experiences occurring more often than with placebo, regardless of causality assessment:

In adults and adolescents 15 years and older with asthma

In children aged 12 months to 14 years with asthma

In clinical trials of pediatric patients 12 to 23 months and 2 to 5 years of age, SINGULAIR 4 mg administered once daily at bedtime was generally well tolerated (Studies IX and X).
The safety profile in pediatric patients 6 to 14 years of age was generally similar to placebo and the adult safety profile shown in the table above.
Additional adverse events in pediatric patients varied by age and were reported regardless of causality assessment. These included upper respiratory infection, rash, fever, otitis, tonsillitis, rhinitis, diarrhea, wheezing, gastroenteritis, pneumonia, and conjunctivitis.

Study Designs

Study IX: A 6 week, double-blind, placebo-controlled study of 172 pediatric patients aged 12 to 23 months, 124 of whom were treated with SINGULAIR.

Study X: SINGULAIR has been evaluated for safety in 573 pediatric patients aged 2 to 5 years in single- and multiple-dose studies.

Study XI: A 56-week, multicenter, double-blind, randomized, active- and placebo-controlled parallel group study of 360 pediatric patients with mild asthma 6 to 8 years of age. Patients were randomized to receive SINGULAIR 5 mg once daily, beclomethasone dipropionate (168 mcg twice daily with a spacer device; total daily dose=336 mcg). or placebo. THe study compared the effect on linear growth of SINGULAIR vs placebo and beclomethasone, respectively. For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks.

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Important Information

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

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

Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.

Safety and effectiveness of SINGULAIR in patients younger than 12 months have not been established.

Patients should be advised to take SINGULAIR daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled.