Auxiliary to the treatment of mild or moderate chronic asthma, if treatment with inhaled corticosteroids and short-acting β-agonists used temporarily is satisfactory. The preparation is also indicated in the prevention of asthma, in which the dominant symptom is exercise-induced bronchoconstriction. In patients aged 2 to 14 years, the preparation may be an alternative to low-dose inhaled corticosteroids in patients with mild severe asthma who have not had a history of severe asthma attacks that require oral corticosteroids and patients who have not they are able to use inhaled corticosteroids. Patients from 15 years of age with asthma who are indicated for the treatment of asthma may 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 for chewing and chewing contains 4 mg or 5 mg of montelukast in the form of sodium salt; 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 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 reduce the dose of oral corticosteroids when used concomitantly with montelukast. Due to the risk of Churg-Strauss syndrome, special attention should be paid when the patient develops symptoms of eosinophilia, rash of vascular origin, worsening of pulmonary symptoms, cardiac complications and / or neuropathy; if these symptoms occur, the treatment regimen should be re-examined and verified. In patients with aspirin-induced asthma, despite the treatment with montelukast, the use of Acetylsalicylic acid and 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 montelukast in children under 2 years have not been established. 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. Post-marketing adverse reactions: increased bleeding tendency, hypersensitivity reactions (including anaphylaxis, eosinophil infiltrates in the liver), sleep disorders (including nightmares), hallucinations, insomnia, irritability, nervousness, agitation (including aggressive behavior) ), dizziness, drowsiness, paresthesia or hypoesthesia, seizures, palpitations, diarrhea, dry mouth, indigestion, nausea, vomiting, increase in serum transaminases (ALAT, AST), cholestatic hepatitis, angioneurotic edema, bruising , urticaria, pruritus, rash, arthralgia, 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 (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. 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. In patients aged 2-14 years with mild persistent asthma, if a control visit (usually within 1 month) fails to achieve satisfactory control of asthma symptoms, consideration should be given to the need for additional or different anti-inflammatory therapy as per 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.
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