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Acute Asthma: Montelukast is not indicated for the treatment of acute asthma attacks, including status asthmaticus. Patients should have appropriate short-acting inhaled beta-agonist medication available to treat asthma exacerbations.
However, therapy with montelukast can be continued during acute asthmatic attacks.
Patients taking montelukast should not discontinue or reduce the dosage of other medicines for asthma unless directed by a physician.
Aspirin Sensitivity: Avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast in patients with known aspirin sensitivity.
Neuropsychiatric Events: Neuropsychiatric events have been reported in patients taking montelukast. These postmarketing reports include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Patients should inform their physician if these changes occur.
Eosinophilic Conditions: Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy consistent with Churg-Strauss syndrome have been reported in patients with asthma being treated with montelukast.
Effects on Ability to Drive and Use Machines: Montelukast is not expected to affect patients' physical coordination (e.g., driving, operating machinery). However, in very rare cases, individuals have reported dizziness or drowsiness.
Use in Children: The safety and efficacy of montelukast in infants younger than 6 months old have not been established.
Use in Elderly: There were no age-related differences in the efficacy or safety profile of montelukast, but greater sensitivity of some older individuals cannot be ruled out.
