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Asthma and Allergic Rhinitis: 1 tab daily in the evening.
Asthma and/or Seasonal Allergic Rhinitis: Adults ≥15 years: One 10-mg tablet daily. Children 6-14 years: One 5-mg chewable tablet daily, 2-5 years: One 4-mg chewable tablet or 1 sachet of 4-mg oral granules daily, 12 months-2 years: 1 sachet of 4-mg oral granules daily.
Therapy with Montelukast in Relation to Other Treatments for Asthma: Montelukast can be added to a patient's existing treatment regimen.
Reduction in Concomitant Therapy: Bronchodilator Treatments: Montelukast can be added to the treatment regimen of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the 1st dose), the patients bronchodilator therapy can be reduced as tolerated.
Inhaled Corticosteroids: Treatment with montelukast provides additional clinical benefit to patients treated with inhaled corticosteroids. A reduction in the corticosteroid dose can be made as tolerated. The dose should be reduced gradually with medical supervision. In some patients, the dose of inhaled corticosteroids can be tapered off completely. Montelukast should not be abruptly substituted for inhaled corticosteroids.
Impaired Hepatic Function: No dosage adjustment is required in patients with mild to moderate hepatic insufficiency. There are no clinical data in patients with severe hepatic insufficiency.
Renal Failure: No dosage adjustment is recommended in these patients.
Elderly: No dosage adjustment in the elderly is required.
General Recommendations: The therapeutic effect of montelukast on parameters of asthma control occurs within 1 day. Montelukast tablets, chewable tablets and oral granules can be taken with or without food. Patients should be advised to continue taking montelukast while their asthma is controlled, as well as during periods of worsening asthma. No dosage adjustment is necessary for pediatric patients, for the elderly, for patients with renal insufficiency, or mild to moderate hepatic impairment, or for patients of either gender.
Montelukast is a long-term controller medication which should not be substituted for short acting β-agonists. It is effective alone or in combination with other prophylactic agent. Montelukast is a preventive agent, which should be used in addition to other drugs for the management of asthma.
Administration: Montelukast should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs.
Oral Granules: Montelukast oral granules can be administered either directly in the mouth, or mixed with a spoonful of cold or room temperature soft food (eg, applesauce) or dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk. The sachet should not be opened until ready to use. After opening the packet, the full dose of montelukast oral granules must be administered immediately (within 15 mins). If mixed with food or dissolved in baby formula or breast milk, montelukast oral granules must not be stored for future use. Montelukast oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration.
