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 used short-acting β-agonists are unsatisfactory. In patients aged 2 to 14 years with mild severe asthma who have not recently experienced severe asthma attacks requiring oral corticosteroids, and patients unable to use inhaled corticosteroids, the drug may be used instead of low-dose inhaled corticosteroids . In patients over 15 years, when the medicine is used to treat asthma, it can also relieve the symptoms of seasonal allergic rhinitis. The preparation is also used in the prevention of asthma, in which the spasm of the bronchi is caused mainly by physical effort.
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 - cysteinyl leucrienes - eicosanoids with a strong inflammatory action. Bronchodilation was observed within 2 hours of administration. The bronchodilatory action induced by montelukast enhances the effect of the β-agonist. Montelukast inhibits the early and late phase of bronchial spasm response after exposure to the allergen. 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 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 hours; the mean maximum concentration is 66% higher, while the minimum concentration is lower compared to the value achieved in adults using the tablet. 10 mg. The drug is associated with plasma proteins in over 99%. It is extensively metabolised by 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 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. 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: sleep disorders (including nightmares), hallucinations, insomnia, irritability, anxiety, agitation (including aggressive behavior), tremors, depression, suicidal thoughts and behaviors (very rarely), dizziness, drowsiness, paresthesia or hyposthesia, convulsions, palpitations, diarrhea, dry mouth, indigestion, nausea, vomiting, increased serum transaminases, cholestatic hepatitis, arthralgia, muscle pain (including muscle spasms), increased propensity to bleeding, weakness or fatigue, malaise, edema, fever, angioneurotic edema, bruising, urticaria, pruritus, rash, erythema nodosum, hypersensitivity reactions, including anaphylactic reactions, eosinophilic infiltrates in the liver. Very rare cases of Churg-Strauss syndrome have been reported in patients with asthma treated with montelukast.
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 (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. In patients with bronchoconstriction induced by exercise, it may be necessary to use inhaled corticosteroids, therefore the patient should be evaluated after 2-4 weeks of montelukast therapy, in the absence of a satisfactory response, additional or different treatment should be considered.
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