In the alternative to the treatment of asthma in patients with mild or moderate persistent asthma, in whom the effects of treatment with inhaled corticosteroids and short-acting β-adrenomimetic drugs that are used temporarily are unsatisfactory. The drug 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. In patients with the preparation in the form of tablets. powl. 10 mg is used to treat asthma, it can also relieve the symptoms of seasonal allergic rhinitis. 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.
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. powl. 10 mg contain lactose.
Action:
Antiasthmatic drug for general use, highly selective CysLT leukotriene receptor antagonist1. Montelukast inhibits bronchoconstriction induced by inhalation LTD4. Bronchodilation was observed within 2 h after oral 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 peripheral blood and 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 h. The drug is associated with plasma proteins in more than 99%, is intensively metabolised in the liver with the participation of CYP3A4, CYP2A6 and CYP2C9. The drug and its metabolites are excreted almost exclusively in the bile.
Contraindications:
Hypersensitivity to montelukast or any of the excipients.
Precautions:
The medicine can not be used to treat acute asthma attacks. You should not substitute for montelukast corticosteroids in inhaled or oral form. There are no data available to indicate that the dose of oral corticosteroids may be reduced when Montelukast is co-administered. Because of 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, deterioration of pulmonary symptoms, cardiac complications and / or neuropathy. There are no data on the use of the preparation in patients with severe hepatic impairment. The safety and efficacy of montelukast in children under 2 years have not been established. 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. 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.
Side effects:
Common: in children 6-14 years - headache; in children 2-5 years - stomach ache and increased thirst.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, somnambulism, irritability, anxiety, restlessness, agitation, including aggressive or hostile behavior, depression, dizziness, drowsiness, paraesthesia and / or hypoesthesia, convulsive attacks, nosebleeds, 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.
Dosage:
Orally. Adults and adolescents ≥ 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 required in 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 . 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.
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