the product in the database has an inactive status
indications:
Auxiliary to the treatment of mild and moderate chronic bronchial asthma in patients aged 2-5 years (table for chewing and chewing 4 mg), 6-14 years (table for chewing and chewing 5 mg) or ≥15 years (table) 10 mg) in which treatment with inhaled corticosteroids and "ad-hoc" short-acting β-agonists does not provide adequate clinical control of asthma symptoms. Prevention of bronchial asthma in patients ≥ 2 years old (table for chewing 4 mg), ≥6 years (table for chewing and chewing 5 mg) or ≥15 years (10 mg table), in which the characteristic dominant is exercise bronchospasm. Additionally chewable tablets: instead of small doses of inhaled corticosteroids in patients aged 2-5 years (chewable tablets 4 mg) or 6-14 years (chewable tablets 5 mg) with chronic mild asthma, which in recent years have not experienced 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.
Composition:
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. for chewing and chewing 4 mg and 5 mg contain aspartame and mannitol. Table. powl. 10 mg contain lactose.
Action:
Antiasthmatic drug for general use, highly selective CysLT leukotriene receptor antagonist1. CysLT receptors are associated with the pathophysiology of asthma and allergic rhinitis. Montelukast inhibits bronchoconstriction induced by the action of cysteinyl leuctrienes, 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 maximum concentration is achieved after 2 h. 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.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Precautions:
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. In patients with asthma associated with hypersensitivity to Acetylsalicylic acid, despite the treatment with montelukast, the use of Acetylsalicylic acid or other NSAIDs should be avoided. There are no data on the use of the preparation in patients with severe hepatic impairment. The safety and efficacy of the board has not been established. for chewing and chewing 4 mg 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.
Pregnancy and lactation:
The drug can be used during pregnancy and breastfeeding only when it is absolutely necessary.
Side effects:
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 increased thirst. Adverse reactions observed after marketing: increased bleeding tendency, hypersensitivity reactions (including anaphylactic reactions, eosinophil infiltrates in the liver), sleep disorders (including nightmares), hallucinations, insomnia, irritability, nervousness, agitation (including behavior aggressive), tremors, depression, very rarely suicidal thoughts and behaviors, dizziness, drowsiness, paraesthesia or hypoesthesia, fits, palpitations, epistaxis, diarrhea, dry mouth, indigestion, nausea, vomiting, transaminase elevation in serum (ALT, AST), cholestatic hepatitis, angioneurotic edema, bruising, urticaria, pruritus, rash, erythema nodosum, joint pain, muscle aches and cramps, asthenia or fatigue, malaise, edema. Very rare cases of Churg-Strauss syndrome have been reported during treatment with montelukast in patients with bronchial asthma.
Dosage:
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. 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 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 necessary in elderly patients with renal insufficiency or mild to moderate hepatic impairment. For patients aged 2-14 years with mild persistent asthma, if satisfactory asthma control can not be achieved during treatment after an attack (usually within 1 month), the need for an additional or different anti-inflammatory drug should be considered in accordance with the asthma treatment regimen . Exercise-induced bronchoconstriction may be the predominant 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 previously used treatment.
(C)
