Index of drugs

Auxiliary to the treatment of asthma in patients with mild or moderate asthma, in whom the effects of treatment with inhaled corticosteroids and short-acting β-adrenomimetics in short-term use are unsatisfactory. In patients with bronchial asthma, the preparation simultaneously relieves the symptoms of seasonal allergic rhinitis. The preparation is also used in the prevention of asthma, in which the spasm of the bronchi is caused mainly by physical effort. Table. for chewing and chewing at a dose of 4 mg and 5 mg can be used instead of low doses of inhaled corticosteroids in patients with mild severe asthma who have not recently experienced severe asthma attacks requiring oral corticosteroids, and in patients who do not they can use inhaled corticosteroids. Table. For chewing and chewing 4 mg are indicated for use in children 2-5 years. Table. for chewing and chewing 5 mg are indicated for use in children 6-14 years. Table. powl. 10 mg - for patients from 15 years.

1 tabl chewing and chewing contains 4 mg or 5 mg; 1 tabl powl. contains 10 mg of montelukast in the form of sodium salt. Table. chewing and chewing contains aspartame. Table. powl. contains lactose.

Antiasthmatic drug for general use, highly selective CysLT leukotriene receptor antagonist₁. Montelukast inhibits bronchoconstriction induced by inhalation LTD₄ - cysteinyl leucrienes - eicosanoids with a strong inflammatory action. Bronchodilation was observed within 2 hours of administration. The bronchodilatory activity induced by montelukast enhances the effect of β-agonist. Montelukast inhibits the early and late phase of bronchial spasm response after exposure to the allergen. Decreases the number of eosinophils in the peripheral blood and in the airways, improves clinical control of asthma. After oral administration, it is rapidly absorbed from the gastrointestinal tract. In adults after administration on an empty stomach tabl. powl. 10 mg maximum plasma concentration occurs within 3 h, the average bioavailability is 64%, the standard meal does not affect bioavailability. In adults after administration on an empty stomach tabl. For chewing and chewing 5 mg the maximum plasma concentration occurs within 2 h, the average bioavailability is 73%, the standard meal reduces it to 63%. In children 2-5 years after administration on an empty stomach tabl. for chewing and chewing 4 mg maximum concentration is achieved within 2 hours; the mean maximum concentration is 66% higher, while the minimum concentration is lower compared to the value achieved in adults using the tablet. 10 mg. The drug is associated with plasma proteins in over 99%. It is extensively metabolised by CYP3A4, CYP2A6 and CYP2C9. The drug and its metabolites are excreted almost exclusively in the bile.

Hypersensitivity to montelukast sodium or other components of the preparation.

The medicine can not be used to treat acute asthma attacks. You should not suddenly replace montelukast with corticosteroids in inhalable or oral form. There are no data available to indicate that the dose of oral corticosteroids may be reduced when Montelukast is co-administered. Due to the risk of Churg-Strauss syndrome, caution should be used and the treatment regimen should be re-evaluated if the patient develops eosinophilia, vascular rash, worsening of lung symptoms, cardiac complications and / or neuropathies. The 10 mg dose can be used as an adjunct in patients in whom other medicines such as inhaled corticosteroids do not provide adequate asthma control. The use of 4 mg and 5 mg as an alternative therapy instead of low-dose inhaled corticosteroids in patients with mild asthma should be considered only when patients have not recently experienced severe asthma attacks requiring oral corticosteroids and if patients are unable to use inhaled corticosteroids; if the control visit (usually within 1 month) fails to adequately control the symptoms of asthma, consideration should be given to including an additional anti-inflammatory drug or changing the drug according to the asthma treatment regimen; the degree of improvement in asthma symptoms should be periodically evaluated. Table. 4 mg: In patients with bronchoconstriction induced by exercise, it may be necessary to use inhaled corticosteroids, therefore the patient should be evaluated for 2-4 weeks.montelukast therapy, in the absence of a satisfactory response, additional or other treatment should be considered. Table. chewing and chewing 4 mg are not recommended for use in children under 2 years. Table. chewing and chewing contains aspartame - they can be harmful for patients with phenylketonuria. Table. powl. 10 mg contain lactose - should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

It can only be used during pregnancy if it is absolutely necessary. Do not use the product during breastfeeding.

Common: in adults and adolescents from 15 years - abdominal pain and headache; in children 6-14 years - headache; in children 2-5 years - stomach ache and thirst. Post-marketing adverse reactions: palpitations, increased bleeding tendency, dizziness, drowsiness, paresthesia, hypoesthesia, convulsions, diarrhea, dry mouth, indigestion, nausea, vomiting, angioneurotic edema, bruising, urticaria , pruritus, rash, erythema nodosum, joint pain, muscle pain (including muscle spasms), weakness, fatigue, malaise, edema, hypersensitivity reactions, anaphylactic reactions, eosinophil infiltrates in the liver, increased transaminases (ALAT, AST) in serum , cholestatic hepatitis, sleep disorders, nightmares, hallucinations, insomnia, irritability, anxiety, anxiety, agitation, aggressive behavior, tremors, depression, suicidal thoughts and behaviors. Very rare cases of Churg-Strauss syndrome have been reported in patients with asthma treated with montelukast.

Orally. Adults and adolescents from 15 years with asthma or asthma and concurrent seasonal allergic rhinitis: 1 tablet. powl. 10 mg once a day in the evening (regardless of the meal). Children 6-14 years: 1 tabl. for chewing and chewing 5 mg once a day in the evening. Children 2-5 years: 1 tabl. for chewing and chewing 4 mg once a day in the evening. Table. chewing and chewing take 1 h before or 2 h after a meal. The therapeutic effect of montelukast on the levels of asthma control is visible on the first day after starting admission. Patients should be advised that treatment should be continued both when the symptoms are under control and during periods of exacerbation. Table. 10 mg should not be used simultaneously with other preparations containing the same active substance. The 10 mg dose can be added to the previously used treatment regimen. No dosage adjustment is necessary in patients with renal insufficiency, mild to moderate hepatic impairment, and in the elderly. There are no data available for patients with severe hepatic impairment.