Montelukast sodium.
The therapeutic effect of montelukast sodium on parameters of asthma control occurs within 1 day. Montiget tablets and chewable tablets can be taken with or without food. Patients should be advised to continue taking the drug while their asthma is controlled as well as during periods of worsened asthma.
Montiget should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only 1 tab or 1 sachet daily in the evening.
Asthma and Seasonal Allergic Rhinitis: Adults and adolescents ≥15 years: One 10 mg tab daily.
Pediatric Patients 6-14 years: One 5 mg chewable tab daily.
Pediatric Patients 2-5 years: One 4 mg chewable tab or one 4 mg sachet of pediatric granules daily.
Use of Montiget in Relation to Other Treatment for Asthma: Montiget can be added to a patient's existing treatment regimen: Bronchodilator: Montiget can be added to the treatment of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the 1st dose), the patient's bronchodilator therapy can be reduced as tolerated.
Inhaled Corticosteroids: Treatment with Montiget 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 the inhaled corticosteroids can be tapered off completely. Montiget should not be abruptly substituted for inhaled corticosteroids.
Administration: Montiget Pediatric Granules: Montiget 4 mg pediatric granules can be administered either directly in the mouth or mixed with a spoonful of cold or warm temperature soft foods. The sachet should not be opened until ready to use. After opening the sachet, the full dose (with or without food) must be administered within 15 min. If mixed with food, Montiget pediatric granules must not be stored for future use. Discard any unused portion. Montiget pediatric granules are not intended to be dissolved in liquid for administration. However, liquids may be taken subsequent to administration.
Montelukast sodium is generally well tolerated. However, following are the adverse effects reported which usually were mild and did not require discontinuation of therapy. Hypersensitivity reactions (including anaphylaxis, angioedema, rash, pruritus, urticaria and very rarely, hepatic eosinophillic infiltration).
Dream abnormalities, hallucinations, palpitations, drowsiness, irritability, restlessness, insomnia, increased sweating and headache.
Other adverse effects include nausea, vomiting, dyspepsia, diarrhea, abdominal pain, myalgia including muscle cramps, increased bleeding tendency, bruising edema, tremor, dry mouth, vertigo and arthralgia.
