Kastair EZ Tab/Kastair Special Precautions

Kastair EZ Tab 4 mg: Neuropsychiatric Events: Neuropsychiatric events have been reported in adult, adolescent and pediatric patients taking montelukast with or without a previous history of psychiatric disorders. These postmarketing reports include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia, hallucinations, insomnia, irritability, memory impairment, obsessive-impulsive disorders, restlessness, somnambulism, suicidal thoughts and behavior (including completed suicide), tic, and tremor. Patients should inform their physician if these changes occur.
Patients should discontinue montelukast and inform their physician immediately if these changes or new neuropsychiatric symptoms occur. Neuropsychiatric events have been reported mostly during montelukast treatment, but some were reported after discontinuation of montelukast treatment. Therefore, continuous monitoring and supportive care is recommended until symptoms have resolved. If neuropsychiatric events occur, the benefits and risks of restarting treatment with montelukast must be re-evaluated.
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. In almost all cases, these events were associated with reduction (tapered dosage) or withdrawal of oral or high-dose inhaled corticosteroid therapy. Patients and/or caregivers should be advised to report symptoms (i.e., feeling of pins and needles, numbness of extremities, flu-like symptoms, rash, sinusitis) immediately to their physician.
Aspirin Sensitivity: Patients with known aspirin sensitivity should be advised to avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast. Although montelukast can improve airway function in asthmatics with aspirin sensitivity, the drug has not been shown to shorten the bronchoconstrictor response to aspirin or other NSAIDs in such patients.
Acute Asthma: Montelukast is not indicated for the treatment of acute asthma attacks, including status asthmaticus. Patients should have appropriate rescue medications (e.g., short-acting inhaled β-agonist) available to treat asthma exacerbations. However, therapy with montelukast can be continued during acute asthmatic attacks.
While using montelukast, patients should consult a physician for medical advice if more than the recommended dose of short-acting inhaled bronchodilators is needed.
Patients taking montelukast should not discontinue or reduce the dosage of other medicines for asthma unless directed by a physician.
Exercise-induced bronchospasm: Montelukast should not be used as monotherapy for prevention of exercise-induced bronchospasm. Patients who experience exacerbations of asthma after exercise should continue their usual regimen of inhaled β-agonist for prophylaxis and have a short-acting orally inhaled β-agonist available for rescue. Daily administration of montelukast for the chronic treatment of asthma has not been established to prevent acute episodes of exercise-induced bronchospasm.
Concomitant Use with Corticosteroids: While the dose of inhaled corticosteroids may be reduced gradually under medical supervision, montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Renal Impairment: No dosage adjustment is required for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. There is no available data on patients with severe hepatic impairment or hepatitis.
Kastair EZ Tab 5 mg/Kastair: 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: Kastair EZ Tab 4 mg: The safety and effectiveness of montelukast in pediatric patients vary depending on the therapeutic indication. The efficacy and safety of the drug in this population are supported by adequate and well-controlled studies and by extrapolation from demonstrated efficacy studies in various age groups, including adolescents and adults.
Data on montelukast 4 mg tablet and granules have not been established in patients with asthma below 6 months of age, patients with perennial allergic rhinitis below 6 months of age; patients with seasonal allergic rhinitis below 2 years of age, and patients with exercise-induced bronchoconstriction below 2 years of age.
Kastair EZ Tab 5 mg/Kastair: The safety and efficacy of Montelukast in infants younger than 6 months old have not been established.
Use in the Elderly: Kastair EZ Tab: 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. No dosage adjustment is required for the elderly.