Index of drugs

An additional drug in the treatment of mild and moderate chronic bronchial asthma in patients aged 6 months-5 years (granules 4 mg), 2-5 years (table for chewing and chewing 4 mg), 6-14 years (table for chewing and chewing 5 mg) or> 15 years (10 mg surface area) in which the control of symptoms can not be achieved by means of inhaled corticosteroids and short-acting short-acting β-agonists. Prevention of bronchial asthma in patients ≥ 2 years old (granules 4 mg, chewable tablets 4 mg), ≥6 years (chewable tablets 5 mg) or ≥15 years (10 mg table) , in which the dominant feature is exertional bronchospasm. In addition, chewable granules and tablets: instead of small doses of inhaled corticosteroids in patients aged 2-5 years (4 mg granules, chewable tablets 4 mg) or 6-14 years (chewable tablets 5 mg) with chronic mild asthma, who recently did not have severe asthma attacks requiring the use of oral corticosteroids and who are unable to use inhaled corticosteroids properly. In patients with asthma, where there are indications for the use of montelukast, the drug (10 mg total count) may relieve the symptoms of seasonal allergic rhinitis.

1 sachet of granules contains 4 mg of montelukast in the form of sodium salt. 1 tabl for chewing and chewing contains 4 mg or 5 mg of montelukast in the form of sodium salt; Table. chewing and chewing contains aspartame and Allura red. 1 tabl powl. contains 10 mg; Table. powl. 10 mg contain lactose.

An anti-asthmatic drug for general use, a highly selective CysLT1 leukotriene receptor antagonist. Montelukast inhibits bronchoconstriction induced by inhalation of LTD4 - cysteinyl leachrienes - eicosanoids with a strong inflammatory action. Bronchodilation was observed within 2 hours of administration. The drug inhibits the early and late phase of bronchial spasm response after exposure to the allergen. It reduces the number of eosinophils in the airways and peripheral blood, 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 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 reached after 2 hours. In adults, 4 mg granules and tablets For chewing and chewing 4 mg administered on an empty stomach are bioequivalent. In children from 6 months to 2 years, the maximum concentration is obtained in 2 hours after administration of the granulate and it is almost twice as high as in adults receiving tablets. 10 mg. The drug is associated with plasma proteins in more than 99%, it is metabolised in the liver (mediated by CYP3A4, CYP2A6, CYP2C9). 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; if an acute asthma attack occurs, a short-acting inhaled β-agonist should be used. You should not suddenly replace montelukast with corticosteroids in inhalable or oral form. There are no data available to reduce the dose of oral corticosteroids during the concomitant use of montelukast. Due to the risk of Churg-Strauss syndrome, special attention should be paid when the patient develops eosinophilia, vascular rash, exacerbation of pulmonary symptoms, cardiac complications and / or neuropathy; if these symptoms occur, the treatment regimen should be re-examined and verified. Treatment with montelukast does not slow patients with aspirin-related asthma from bans using Acetylsalicylic acid and other NSAIDs. There are no data on the use of the preparation in patients with severe hepatic impairment.There is limited data on the use of the drug in children from 6 months to 2 years with chronic bronchial asthma. Montelukast is not recommended for use in children <6 months. Table. chewing and chewing contains aspartame - they can be harmful for patients with phenylketonuria; in addition, they contain Allura red, which can cause allergic reactions. 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 from available databases on the use of the drug during pregnancy does not indicate a causal relationship between montelukast and the occurrence of congenital defects (ie limb defects) that have been rarely observed worldwide after the medicine has been introduced.

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, bronchial asthma, diarrhea, eczematous dermatitis, rash. Adverse reactions observed after marketing: very common - upper respiratory tract infections; often - diarrhea, nausea, vomiting, increased serum transaminases, rash, fever; uncommon - hypersensitivity reactions including anaphylaxis, sleep disorders including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness, agitation, including aggressive behavior or hostility, depression, dizziness, drowsiness, paresthesia and / or hypoesthesia, seizures convulsive, bleeding from the nose, dry mouth, indigestion, bruising, urticaria, pruritus, joint pain, muscle pain, including muscle spasms, weakness and / or fatigue, malaise, edema; rarely - increased bleeding tendency, tremor, palpitations, angioneurotic edema; very rarely - eosinophil infiltrates in the liver, hallucinations, suicidal thoughts and behaviors, 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 5 mg once a day in the evening, 1 hour before or 2 h after a meal. Children 2-5 years: 1 tabl. for chewing and chewing 4 mg once a day in the evening, 1 h before or 2 h after a meal. Children 6 months -5 years: 1 sachet of granules once a day in the evening; after 2-4 weeks, the response to treatment should be assessed - if no response is given, treatment should be discontinued. Granules should be given to the child either immediately to swallow, or after mixing with a teaspoon of cold or room temperature soft food (eg apple mousse, ice cream, carrot and rice). The sachet should be opened immediately before use. After opening the sachets, you must immediately (within 15 minutes) give the whole granulate. Granules mixed with food must not be stored for later. The granules are not intended to be dissolved in the liquid before administration, the liquid can be given to the child to drink after administration of the drug. The granules can be administered independently of meals. The therapeutic effect of the preparation on asthma control parameters occurs within one day. Taking the medicine should be continued both when the symptoms are under control and during periods of exacerbation. No dose adjustment is required in patients with renal insufficiency, mild to moderate hepatic impairment, and in the elderly. For patients aged 2-14 years with mild persistent asthma, if a control visit (usually within a month) fails to achieve satisfactory asthma control, an additional or different anti-inflammatory drug should be considered in accordance with the asthma treatment regimen. In patients aged 2-5 years, exercise-induced bronchoconstriction may be the main symptom of chronic asthma requiring treatment with inhaled corticosteroids; 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.The 10 mg dose can be added to the previously used treatment regimen.