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

SINGULAIR—Proven efficacy in patients with chronic asthma

Patients

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.
  • Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.

Please see Selected Safety Information about SINGULAIR.

Before prescribing SINGULAIR, please read the Prescribing Information.

See all references.

RESP-1007091-0003 11/11

For general information and other services for physicians

Merck Services Merck OnCall