Asmont, film-coated tablets, 10 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 found in human airways (including smooth muscle cells and macrophages), as well as other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs are involved in the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchospasm, mucus secretion, vascular permeability, and increased eosinophil counts. In allergic rhinitis, CysLTs are released from the nasal mucosa during both early and late phases following allergen exposure and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction.

Montelukast is an active compound that binds with high selectivity and chemical affinity to CysLT1 receptors. Montelukast causes significant blockade of cysteinyl leukotriene receptors in the airways, as demonstrated by its ability to inhibit bronchoconstriction induced by inhaled LTD4 in patients with asthma. Even a low dose of 5 mg causes significant inhibition of LTD4-stimulated bronchoconstriction. Montelukast induces bronchodilation within 2 hours after oral administration; this effect is additive to bronchodilation caused by β-agonists.

Treatment with montelukast inhibits both early- and late-phase bronchospasm by reducing the response to antigens. Montelukast reduces peripheral blood eosinophil counts in adult and pediatric patients, significantly decreases eosinophils in the airways (sputum analysis), and improves clinical asthma control.

Method of administration and dosage

The drug should be taken orally, regardless of food intake.
Adults and adolescents aged 15 years and older: For the treatment of asthma or asthma with concomitant seasonal allergic rhinitis, one 10 mg tablet should be taken once daily in the evening.
To relieve allergic rhinitis symptoms, the timing of administration may be individualized.

General recommendations

The therapeutic effect of the drug on asthma control is usually achieved within 1 day. Patients should be advised to continue taking the medication even when asthma is under control, as well as during exacerbations. The drug should not be taken together with other medicinal products containing montelukast.

No dose adjustment is necessary for elderly patients, patients with renal impairment, or those with mild to moderate hepatic impairment. There are no data on the use of the drug in patients with severe hepatic impairment.

The dosage of the drug is the same for both male and female patients.

Treatment with montelukast in relation to other asthma therapies

Asmont can be prescribed as an add-on to the patient’s existing treatment regimen.

Inhaled corticosteroids
Asmont may be used as add-on therapy when inhaled corticosteroids combined with short-acting β-agonists as rescue medication do not provide adequate disease control.
Inhaled corticosteroids should not be abruptly substituted with Asmont.

Children
The drug is intended for use in children aged 15 years and older. For children under 15, the medication should be used in the form of chewable tablets.