Index of drugs

Granules 4 mgAuxiliary to the treatment of asthma in patients from 6 months to 5 years with mild or moderate chronic asthma, in whom treatment with inhaled glucocorticosteroids and short-acting short-acting β-agonists does not adequately control the symptoms of asthma. It can also be used instead of low-dose inhaled glucocorticosteroids in patients aged 2-5 years with mild severe asthma who have recently experienced severe asthma attacks that require oral glucocorticosteroids and who can not use inhaled glucocorticoids. Prevention of asthma in patients from 2 years, whose dominant symptom is exercise-induced bronchoconstriction.Table. chewable and chewable 4 mg and 5 mg: For help in the treatment of asthma in patients with mild or moderate persistent asthma, in whom the effects of treatment with inhaled glucocorticoids and short-acting short-acting β-agonists do not provide adequate clinical control of asthma symptoms. It can also be used instead of low-dose inhaled glucocorticosteroids in patients with mild severe asthma who have recently experienced severe asthma attacks that require oral glucocorticosteroids and who can not use inhaled glucocorticoids. Prevention of asthma in patients whose predominant symptom is exercise-induced bronchoconstriction. The 4 mg dose is intended for children aged 2-5; 5 mg dose - for children aged 6-14 years.Table. powl. 10 mgAuxiliary to the treatment of asthma in patients with mild or moderate persistent asthma, in whom the effects of treatment with inhaled glucocorticoids and short-acting short-acting β-agonists do not provide adequate clinical control of asthma symptoms. In patients with bronchial asthma, the preparation used to treat asthma simultaneously relieves the symptoms of seasonal allergic rhinitis. Prevention of asthma in patients whose predominant symptom is exercise-induced bronchoconstriction. The 10 mg dose is intended for patients from 15 years.

1 granule sachet (Mini) contains 4 mg; 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. chewable and chewable 4 mg and 5 mg contain aspartame. Table. powl. 10 mg contain 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 oral administration. The bronchodilator effect caused by the β-agonist administration was enhanced by montelukast. Montelukast inhibits the early and late phase of bronchoconstriction after antigen challenge. 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 after 3 h; the average bioavailability after oral administration 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, the maximum concentration is achieved after 2 hours; the average maximum concentration is 66% higher, while the minimum concentration is lower compared to the value achieved in adults after tabl. 10 mg. In children from 6 months to 2 years after administration of 4 mg granules, the maximum concentration occurs after 2 hours. Taking granules simultaneously with apple sauce or a standard high fat meal does not affect the pharmacokinetics. The drug is associated with plasma proteins in over 99%. It is extensively metabolised in the liver.The drug and its metabolites are excreted almost exclusively in the bile.

Hypersensitivity to montelukast or any of the excipients.

It must not be used to treat acute asthma attacks. You should not suddenly replace montelukast with inhaled or oral corticosteroids. There are no data available to reduce the dose of oral corticosteroids when Montelukast is administered concomitantly. Due to the risk of Churg-Strauss syndrome, special attention should be paid when the patient develops eosinophilia, rash associated with vasculitis, worsening of lung symptoms, cardiac complications and / or neuropathy; if these symptoms occur, the treatment regimen should be re-examined and verified. In patients with asthma and hypersensitivity to Acetylsalicylic acid, despite the treatment with montelukast, the use of Acetylsalicylic acid and other NSAIDs should be avoided. There are no data on the use of the drug in patients with severe hepatic impairment. The preparation should not be used with other medicines containing montelukast. The preparation in the form of granules is not indicated in children under 6 months of age, the data on the use of the preparation in children from 6 months to 2 years with chronic asthma are limited. In small children (from 6 months to 2 years), chronic asthma should be diagnosed by a pediatrician or pulmonologist. Table. chewing and chewing 4 mg are not recommended for children under 2 years old. Table. chewing and chewing contains aspartame - they can be harmful for patients with phenylketonuria. In patients with phenylketonuria, it should be taken into account that each for chewing and chewing 4 mg contains 0.674 mg phenylalanine / dose, tabl. for chewing and chewing 5 mg - 0.842 mg phenylalanine / dose. Table. powl. 10 mg contain lactose - should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The drug can be used during pregnancy and breastfeeding only when it is absolutely necessary. The limited number of data on the use of the drug during pregnancy does not indicate a cause and effect relationship between the use of montelukast and the occurrence of malformations (eg limb defects), which were rarely observed after the introduction of the medicine.

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; in children 6 months-2 years - hyperkinesia, asthma, diarrhea, eczematous dermatitis, rash. Adverse reactions observed after marketing: very common - upper respiratory tract infections; often - diarrhea, nausea, vomiting, increased ALT and AST, rash, fever; uncommon - hypersensitivity reactions including anaphylaxis, sleep disorders including nightmares, insomnia, somnambulism, anxiety, agitation, including aggressive or hostile behavior, depression, attention deficit hyperactivity disorder, including irritability, restlessness, tremor, dizziness, drowsiness , paraesthesia and / or hypoesthesia, fits, nosebleeds, dry mouth, indigestion, bruising, urticaria, pruritus, joint pain, muscle pain, including muscle spasms, weakness and / or fatigue, malaise, edema; rarely - increased bleeding tendency, impaired memory, attention disorders, palpitations, angioneurotic edema; very rarely - eosinophil infiltrates in the liver, hallucinations, confusion, suicidal thoughts and behaviors (suicidal tendencies), Churg-Strauss syndrome, hepatitis (including cholestatic, hepatocellular carcinoma and liver damage with mixed etiology), erythema nodosum, erythema multiforme.

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. Granules: children from 6 months to 5 years: 1 granules 4 mg granules daily, in the evening (regardless of the meal); after 2-4 weeks of treatment, the patient's condition should be evaluated, in the absence of response, the drug should be discontinued. The therapeutic effect of the preparation on asthma control parameters occurs within one day.Taking the drug should be continued both when the symptoms are under control and during periods of exacerbation of asthma symptoms. No dose adjustment is required in patients with renal insufficiency, mild to moderate hepatic impairment, and in the elderly. Montelukast is not recommended for monotherapy in patients with moderate persistent asthma. The use of montelukast instead of small doses of inhaled corticosteroids in children from 2 to 14 years with mild mild asthma should be considered only if patients have recently experienced severe asthma attacks requiring oral glucocorticosteroids and if patients are unable to use inhaled glucocorticosteroids. If a control visit (usually within a month) fails to adequately control the symptoms of the disease, consideration should be given to including an additional anti-inflammatory drug or changing the drug according to the asthma treatment regimen. The degree of self-control of asthma should be periodically assessed. In patients aged 2-5 years, exercise-induced bronchoconstriction may be the main symptom of chronic asthma requiring treatment with inhaled glucocorticoids; the patient should be evaluated after 2-4 weeks of montelukast treatment, if the response to treatment is not satisfactory, additional or different treatment should be considered. If Montelukast is used as an adjunctive therapy for inhaled glucocorticoids, montelukast should not be abruptly substituted for inhaled glucocorticoids. The 10 mg dose can be added to the current treatment schedule; the preparation may be used as an aid in patients in whom treatment with inhaled glucocorticosteroids and short-acting short-acting β-agonists is not adequately controlled. The granules can be administered directly orally or after mixing with a spoon of soft food (eg apple mousse, ice cream, carrot with rice), cold or at room temperature. The contents of the sachet should be given to the child immediately after opening (within 15 minutes). Granules mixed with food can not be stored; the granulate is not intended for administration in a liquid form, it can be taken with liquid.