Montelukast Sandoz Dosage/Direction for Use

The 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 dose adjustment within this age group is necessary.
Method of administration: For oral use.
General recommendations: 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.
No dose 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 dose is the same for both male and female patients.
Montelukast as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma: 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 (see Indications/Uses). 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.
Therapy with montelukast in relation to other treatments for asthma: When treatment with montelukast is used as add-on therapy to inhaled corticosteroids, montelukast should not be abruptly substituted for inhaled corticosteroids (see Precautions).