- Approval Id
- 7363796075e99ce1
- Drug Name
- M-KAST 4 CHEWABLE TABLETS 4MG
- Product Name
- M-KAST 4 CHEWABLE TABLETS 4MG
- Approval Number
- SIN16465P
- Approval Date
- 2022-04-03
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, CHEWABLE
- Dosage
- <p><strong>Posology and method of administration:</strong><br>
<u>Posology</u><br>
This medicinal product is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, a granule formulation is available. The recommended dose for paediatric patients 2–5 years of age is one 4 mg chewable tablet daily to be taken in the evening.</p>
<p><u>General recommendations:</u><br>
The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma.</p>
<p>No dosage adjustment is necessary 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.</p>
<p><u>Therapy with Montelukast in relation to other treatments for asthma.</u><br>
Montelukast can be added to a patient’s existing treatment regimen.</p>
<p>Reduction in Concomitant Therapy:</p>
<p>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 first dose), the patient’s bronchodilator therapy can be reduced as tolerated.</p>
<p>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.</p>
<p>10 mg film-coated tablets are available for adults 15 years of age and older.</p>
<p><u>Paediatric population</u><br>
Do not give Montelukast 4 mg chewable tablets to children less than 2 years of age. The safety and efficacy of Montelukast 4 mg chewable tablets in children less than 2 years of age has not been established.<br>
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.</p>
<p><u>Method of administration</u><br>
Oral use.<br>
The tablets are to be chewed before swallowing.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications:</strong><br>
Montelukast is indicated in pediatric patients 2 year of age and older 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.</p>
<p>Montelukast is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in pediatric patients 2 years of age and older, and perennial allergic rhinitis in pediatric patients 2 year of age and older). 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.</p>
- Contraindications
- <p><strong>Contraindications:</strong><br>
Hypersensitivity to the active substance or to any of the excipients.</p>
- Atc Code
- R03DC03
- Atc Item Name
- montelukast
- Pharma Manufacturer Name
- APOTHECA MARKETING PTE LTD
