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Administration: Asthmatin: Asthmatin 10 should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening.
Asthmatin 4: ASTHMATIN 4 CHEWABLE TABLETS 4MG is administered orally. The tablets are to be chewed before swallowing.
Dosage: Asthmatin: Adult and adolescents 15 years of age and older with asthma or allergic rhinitis: 10 mg once daily.
Asthmatin 4: This medicinal product is to be given to a child under adult supervision. The recommended dose for paediatric patients 2-5 years of age is one 4 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.
The tablets are to be chewed before swallowing.
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 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.
Do not give montelukast 4 mg chewable tablets to children less than 2 years of age. The safety and efficacy of 4 mg chewable tablets in children below 2 years of age has not been established.
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. 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.
Montelukast as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction: In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids. Patients should be evaluated after 2 to 4 weeks of treatment with montelukast. If satisfactory response is not achieved, an additional or different therapy should be considered.
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.
