Indicated for:

Asthma:

• The prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

Exercise-Induced Bronchoconstriction (EIB):

• The prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

Allergic Rhinitis:

• The relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.

SINGULAIR is not indicated for the treatment of an acute asthma attack.

SINGULAIR is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available.

Therapy with SINGULAIR can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist. 

Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute SINGULAIR for inhaled or oral corticosteroids.

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 with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal antiinflammatory agents while taking SINGULAIR.

Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood. Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR.

Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.

SINGULAIR contains aspartame, a source of phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria (PKU). Each 4 mg and 5 mg chewable tablet contains 0.674 mg and 0.842 mg of phenylalanine, respectively. Before prescribing SINGULAIR to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including SINGULAIR.

Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal antiinflammatory agents while taking SINGULAIR. Although SINGULAIR is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients

During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated with SINGULAIR during pregnancy. A causal relationship between these events and SINGULAIR has not been established.

A published clinical lactation study reports the presence of montelukast in human milk.

GoToSource

• Use in patients under 6 months of age for allergic rhinitis. GoToSource

• Use in patients under 12 months of age for asthma. GoToSource

• Use in patients under 6 years of age for exercise-induced bronchoconstriction. GoToSource

• Use in patients under 2 years of age for seasonal allergic rhinitis. GoToSource

• Capsular contracture after breast implant surgery. GoToSource

• Prophylactic treatment of migraines. GoToSource

• Obstructive sleep apnea syndrome. GoToSource

• Eosinophilic oesophagitis. GoToSource

• Vulvar vestibulitis. GoToSource

• Dysmenorrhoea in adolescents. GoToSource

• Chronic obstructive pulmonary disease. GoToSource

• Symptoms of cystic fibrosis. GoToSource

• Adjunctive therapy for chronic urticaria. GoToSource

• HIV-associated immune reconstitution disease. GoToSource

• Nasal polyps. GoToSource

Hematuria (blood in urine). GoToSource

Acute hepatitis and churg-strauss syndrome (disease causing inflammation of the blood vessels). GoToSource

Visual hallucinations. GoToSource

Ecchymosis (unusual bruising). GoToSource

Exacerbation of chronic urticaria (hives). GoToSource

Angioedema (swelling). GoToSource

Nightmares, anxiety, aggressiveness, insomnia, irritability, hyperactivity and personality disorder. GoToSource

Acute hepatocellular liver injury. GoToSource

Growth suppression in children. GoToSource

Depression and suicidal thinking and behavior. GoToSource

Hypercholesterolemia (high levels of cholesterol), hypertriglyceridemia (elevated triglyceride levels) and acute pancreatitis. GoToSource 

Pulmonary eosinophilia (accumulation of eosinophils, type of white blood cell, in the lungs). GoToSource

Increased bleeding tendency. GoToSource

Upper respiratory infection. GoToSource 

Seizures, erythema nodosum (skin inflammation), pruritus (itching) and rash. GoToSource

Lawsuits filed for tremors, depression, anxiousness and suicidal thoughts and behavior.