Monast Special Precautions

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 have been reported in patients taking montelukast. Post-marketing reports with montelukast use include agitation including aggressive behaviour or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor hyperactivity (including irritability, restlessness and tremor), somnambulism, suicidal thinking and behaviour (suicidality) and tic. The clinical details of some post-marketing reports involving montelukast appear consistent with a drug-induced effect.
These neuropsychiatric events have been reported in patients with and without a previous history of psychiatric disorder. Neuropsychiatric events have been reported mostly during montelukast treatment, but some were reported after montelukast discontinuation. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of neuropsychiatric events with montelukast use.
Physicians should discuss the benefits and risks of montelukast use with patients and caregivers when prescribing montelukast. Patients and/or caregivers should be advised to be alert for changes in behaviour or for new neuropsychiatric symptoms when taking montelukast. If changes in behaviour are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behaviour occur, patients should be advised to contact a healthcare provider immediately. In many cases, symptoms resolved after stopping montelukast therapy; however, in some cases, symptoms persisted after discontinuation of montelukast. Therefore, patients should be monitored and provided supportive care until symptoms resolve.
Prescribers should carefully evaluate the risks and benefits of continuing treatment with montelukast if such events occur.
Montelukast should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled β-agonists as prophylaxis and have available for rescue a short-acting inhaled β-agonist.
Patients with known aspirin hypersensitivity 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 NSAIDs in aspirin-sensitive asthmatic patients.
In rare cases, patients receiving anti-asthma agents including leukotriene receptor antagonists have experienced 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. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a casual relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving Montelukast.
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.