Asmont, chewable tablets, 5 mg, No. 28 (7×4)

Pharmacological properties

Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released by various cells, including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors located in the human airways and trigger responses such as bronchospasm, mucus secretion, vascular permeability, and increased eosinophil counts. Montelukast is an active compound that selectively and with high affinity binds to CysLT1 receptors. Montelukast causes significant blockade of cysteinyl leukotriene receptors in the airways, as evidenced by its ability to inhibit bronchoconstriction in asthmatic patients induced by inhalation of LTD4. Even a low dose of 5 mg produces substantial inhibition of LTD4-induced bronchoconstriction. Montelukast induces bronchodilation within 2 hours of oral administration; this effect is additive to that of β-agonists.
Montelukast therapy inhibits both early- and late-phase bronchospasm responses and reduces antigen-induced reactions. Montelukast reduces peripheral blood eosinophil counts in both adult and pediatric patients, significantly lowers eosinophil levels in the airways (sputum analysis), and improves clinical asthma control.

Method of administration and dosage
Tablets should be chewed before swallowing.
Patients with bronchial asthma and allergic rhinitis (seasonal and perennial) should take one chewable tablet (5 mg) once daily. For the relief of allergic rhinitis symptoms, the timing of administration may be individualized.
For the treatment of bronchial asthma in children aged 6 to 14 years, the dosage is one chewable tablet (5 mg) once daily in the evening, one hour before or two hours after food. No dosage adjustment is needed for this age group.

General recommendations
The therapeutic effect of the product on asthma control parameters begins within one day. Patients should be advised to continue taking Asmont even when asthma control is achieved, as well as during periods of exacerbation. The dosage is the same for male and female patients.

As an alternative therapy to low-dose inhaled corticosteroids in mild persistent asthma
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The decision to use montelukast as an alternative to low-dose inhaled corticosteroids in children with mild persistent asthma should be made only for patients who have not had recent serious asthma attacks requiring corticosteroids and who are unable to use inhaled corticosteroids effectively.
Mild persistent asthma is defined as symptoms occurring more than once a week but less than once daily, nighttime symptoms more than twice a month but less than once weekly, and normal lung function between episodes.

If satisfactory asthma control is not achieved within one month of montelukast therapy, the need for additional or alternative anti-inflammatory therapy should be considered based on a stepwise approach to asthma management. Patients should be periodically evaluated for asthma control.

Use of montelukast in relation to other asthma treatments
When montelukast is used as add-on therapy to inhaled corticosteroids, abrupt substitution of inhaled corticosteroids with montelukast is not recommended.

Children
Use in children aged 6 to 14 years. For children aged 15 and older, 10 mg montelukast tablets should be used.