Regulatory Information
APOTHECA MARKETING PTE LTD
APOTHECA MARKETING PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**Posology and method of administration** The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening. _General recommendations._ The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Montelukast may be taken with or without food. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma. Montelukast should not be used concomitantly with other products containing the same active ingredient, Montelukast. No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Therapy with Montelukast in relation to other treatments for asthma M-KAST 10 can be added to a patient’s existing treatment regimen. _Bronchodilator Treatments:_ M-KAST-10 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 first dose), the patient’s bronchodilator therapy can be reduced as tolerated. _Inhaled corticosteroids:_ Treatment with M-KAST-10 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. _Paediatric population_ Do not give M-KAST 10 tablets to children less than 15 years of age. The safety and efficacy of M-KAST 10 tablets in children less than 15 years has not been established. 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 4 mg chewable tablets are available for paediatric patients 2 to 5 years of age. 4 mg granules are available for paediatric patients 6 months to 5 years of age. Method of administration Oral use.
ORAL
Medical Information
**Therapeutic indications** Montelukast is indicated in adult for the prophylaxis and chronic treatment of asthma, including the prevention of day- and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. Montelukast is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in adults). Because the benefits of Montelukast may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
**Contraindications** Hypersensitivity to the active substance or to any of the excipients.
R03DC03
montelukast
Manufacturer Information
APOTHECA MARKETING PTE LTD
AUROBINDO PHARMA LIMITED - UNIT VII
Active Ingredients
Documents
Package Inserts
M-Kast Film Coated Tablet 10 mg_PI.pdf
Approved: November 25, 2021