Asthma Attack

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Versus beclomethasone (an ICS)

In clinical studies involving patients aged >15 years with asthma
SINGULAIR vs beclomethasone (an ICS)5,a

FEV
Asthma Attacks
Distribution
Control Days

Similar distribution of individual patient response and nonresponse in FEV11,a

Graph of FEV

Study Design

Study I: Pooled data from two 6-week, double-blind, randomized, placebo- and active-controlled, parallel-group studies of 1,512 asthmatic men and women aged >15 years with FEV1 between 50% and 85% of predicted value. Adult patients with chronic asthma were treated for 6 weeks with either SINGULAIR (10 mg once daily) or inhaled beclomethasone (4 puffs twice daily; total daily
dose=336 mcg). Patients were allowed inhaled albuterol as needed throughout the studies.5

a Dose of beclomethasone studied was a low or starting dose (8 puffs per day, or 336 mcg/day) and was compared with the recommended dose of SINGULAIR for patients aged >15 years (10 mg/day).5 At the time of the study, the approved daily dose of beclomethasone was 6 to 20 puffs per day, or 252 to 840 mcg/day.

SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older and for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.

For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose.

Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB.

SELECTED SAFETY INFORMATION

  • SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.
  • 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.
  • Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
  • Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.

Before prescribing SINGULAIR, please read the Prescribing Information.

See all references.

20951836(5)-02/10-SNG

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