Warning: This product contains aspartame. It is unsuitable for phenylketonurics.
The efficacy of oral Montelukast for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events (eg, agitation, aggression, anxiousness, dream abnormalities, hallucinations, depression, disorientation, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor) have occurred. Since other factors may have contributed to these events, it is not known if they are related to Montelukast. Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur.
The reduction in systemic corticosteroid dose in patients receiving antiasthma agents including leukotriene receptor antagonists has been followed in rare cases by the occurrence of one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. Although a casual relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended when systemic corticosteroid reduction is considered in patients receiving Montelukast.
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast.
Although Montelukast 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 documented aspirin sensitivity.
Do not give Avalair 4mg chewable tablets to children less than 2 years of age. The safety and efficacy of Avalair 4mg chewable tablets in children less than 2 years of age has not been established.
Effects on ability to drive and use machines: Montelukast is not expected to affect a patient's ability to drive a car or operate machinery. However, in very rare cases, individuals have reported drowsiness or dizziness.