Each film-coated tablet contains 5 or 10 mg montelukast, №28
АТС code: RO3D CO3, Other systemic drugs for obstructive airway diseases, leukotriene receptor antagonists, montelukast
The cysteinyl leukotrienes (LTC4, LTD4, and LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions 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 orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg. Bronchodilation was observed within two hours of oral administration. The bronchodilation effect caused by a beta-agonist was additive to that caused by montelukast. Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge. Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum) and inperipheral blood while improving clinical asthma control.
Montelukast 4 mg is indicated in paediatric patients aged 6 to 14 years 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 beta-agonists provide inadequate clinical control of asthma.
Montelukast 4 mg may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 years old 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.
Montelukast 4 mg is also indicated in the prophylaxis of asthma from 6 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
Montelukast 10mg tablets are indicated in the treatment of asthma as add-on therapy in those patients 15 years of age and older 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. In those asthmatic patients 15 years of age and older in whom montelukast 10mg tablets are indicated in asthma, montelukast 10mg tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast 10mg tablets are also indicated in the prophylaxis of asthma in patients 15 years of age and older in which the predominant component is exercise-induced bronchoconstriction.