- Approval Id
- 2dc15327c8269e3c
- Drug Name
- M-KAST 5 CHEWABLE TABLETS 5MG
- Product Name
- M-KAST 5 CHEWABLE TABLETS 5MG
- Approval Number
- SIN16464P
- Approval Date
- 2022-04-03
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, CHEWABLE
- Dosage
- <p><strong>Posology and method of administration:</strong><br>
<u>Posology</u><br>
The recommended dose for paediatric patients 6–14 years of age is one 5 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Montelukast should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary.</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>Montelukast as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma:</u><br>
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids. Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control.</p>
<p><u>Therapy with Montelukast in relation to other treatments for asthma</u><br>
When treatment with montelukast is used as add-on therapy to inhaled corticosteroids, montelukast should not be abruptly substituted for inhaled corticosteroids.</p>
<p>4 mg chewable tablets are available for paediatric patients 2 to 5 years of age.</p>
<p>10 mg tablets are available for adults and adolescents 15 years of age and older.</p>
<p><u>Paediatric population</u><br>
Do not give montelukast 5 mg chewable tablets to children less than 6 years of age. The safety and efficacy of montelukast 5 mg chewable tablets in children less than 6 years of age has not been established.</p>
<p>4 mg chewable tablets are available for paediatric patients 2 to 5 years of age.</p>
<p>4 mg granules are available for paediatric patients 6 months to 5 years of age.</p>
<p>Method of administration</p>
<p>Oral use.</p>
<p>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 the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma.<br>
Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.</p>
<p>Montelukast is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.</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
