Chronic Asthma

The information on this site is intended for health care professionals in the United States and is not intended for the general public.

I AM A HEALTHCARE PROFESSIONAL I AM NOT A HEALTHCARE PROFESSIONAL
Go to AR HCP Site
Allergy HCP
Prescribing Information Patient Information Selected Safety Information Return to singulair.com

For chronic asthma

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

SELECTED SAFETY INFORMATION

  • 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.
  • SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.

SELECTED SAFETY INFORMATION continued below

The efficacy of SINGULAIR for chronic treatment of asthma in patients aged >15 years was demonstrated in 2 (multinational and US) similarly designed trials.
SINGULAIR—significant efficacy across important measures of asthma control1–3

SINGULAIR provided the following benefits compared with placebo

In the multinational study
In the US study


And...SINGULAIR provided significant improvement in FEV1 vs placebo (P<0.001)in both studies; in the multinational study, 7.4% vs 0.7%, respectively, and in the US study, 13.1% vs 4.2%, respectively.1,3

a Study Design: A 12-week, randomized, placebo-controlled, parallel-group trial of 895 asthmatic patients aged >15 years with persistent asthma. Baseline FEV1 was between 50% and 85% of predicted value with β-agonist reversibility of at least 15%. Patients received SINGULAIR, given as one 10-mg tablet daily, inhaled beclomethasone 200 mcg twice daily, or placebo. Short-acting inhaled β-agonist was permitted as needed.1

b Study Design: A 12-week, randomized, double-blind, placebo-controlled study of 681 asthmatic patients age >15 years with baseline FEV1 between 50% and 85% of predicted value and β-agonist reversibility of at least 15%. SINGULAIR was given as one 10-mg tablet daily; short-acting inhaled β-agonist was permitted as needed.2

For the 2 trials (multinational and US), the median age was 33 years (range, 15 to 85); 56.8% were females and 43.2% were males. The ethnic/racial distribution in these studies was 71.6% Caucasian, 17.7% Hispanic, 7.2% other origins, and 3.5% Black. Patients had a mean baseline percent FEV1 of 66% of predicted value (approximate range, 40% to 90%). The coprimary end points in the trials were FEV1 and daytime asthma symptoms.

SELECTED SAFETY INFORMATION (continued)

  • SINGULAIR should not be used as rescue medication to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
  • While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.
  • Patients receiving SINGULAIR should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
  • 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.

Please see Selected Safety Information about SINGULAIR.

Before prescribing SINGULAIR, please read the Prescribing Information.

See all references.

RESP-1007091-0003 01/12

For general information and other services for physicians

Merck Services Merck OnCall