Table. for chewing 4 mg and 5 mg. As an aid to the treatment of asthma in patients with mild to moderate chronic asthma, in whom treatment with inhaled glucocorticosteroids and "ad hoc" short-acting β-agonists does not provide adequate clinical control of asthma symptoms. It can also be used instead of low-dose inhaled glucocorticosteroids in patients with mild persistent asthma who have recently experienced severe asthma attacks that require oral glucocorticosteroids and who can not use inhaled glucocorticoids. The preparation is also indicated in the 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 mg. As an aid to the treatment of asthma in patients with mild to moderate chronic asthma, in whom treatment with inhaled glucocorticosteroids and "ad hoc" short-acting β-agonists does not provide adequate clinical control of asthma symptoms. In asthmatic patients in whom the preparation is indicated for asthma, it can also relieve the symptoms of seasonal allergic rhinitis. The preparation is also indicated in the prevention of asthma in patients whose predominant symptom is exercise-induced bronchoconstriction. The 10 mg dose is intended 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. chewable and chewable 4 mg and 5 mg contain aspartame. 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. It should not be substituted for glucocorticosteroid montelukast in inhaled or oral form. There are no data available to indicate that the dose of oral glucocorticosteroids 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. In patients with asthma associated with hypersensitivity to Acetylsalicylic acid, the use of Acetylsalicylic acid or other NSAIDs should still be avoided despite montelukast treatment. The safety and efficacy of the medicine in children under 2 years has not been established, hence the use in this age group is not recommended. There are no data on the use of the drug in patients with severe hepatic impairment. Montelukast is not recommended for monotherapy in patients with moderate persistent asthma. 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:
It can only be used during pregnancy if 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. The drug should not be used in women who are breastfeeding. There is no data on whether montelukast is excreted in human milk.
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. Post-marketing adverse reactions: increased bleeding tendency, hypersensitivity reactions, anaphylactic reactions, eosinophil infiltrates in the liver, sleep disorders, including nightmares, hallucinations, insomnia, somnambulism, irritability, anxiety, restlessness, agitation, including behavior aggressive or hostile attitude, tremor, depression, suicidal thoughts and behaviors (very rarely), dizziness, drowsiness, paresthesia, hyposthesia, convulsions, palpitations, epistaxis, diarrhea, dry mouth, indigestion, nausea, vomiting, dryness of the oral mucosa, increased serum transaminases, hepatitis (including cholestatic, hepatocellular and liver damage with mixed etiology), angioneurotic edema, bruising, urticaria, pruritus, rash, erythema nodosum, joint pain, muscle pain, (in muscle cramps), swelling, weakness, tiredness, bad self opoczucie. Very rare cases of Churg-Strauss syndrome have been reported in patients with asthma treated with montelukast.
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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