The preparation is indicated as an aid in the treatment of asthma in patients with mild or moderate chronic asthma, in whom treatment with inhaled corticosteroids and short-acting β-agonists used temporarily does not provide adequate clinical control of asthma symptoms. The preparation is also used in the prevention of asthma, in which the dominant symptom is exercise-induced bronchoconstriction. Table. 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 chronic mild asthma, who in recent years did not experience severe asthma attacks requiring the use of oral corticosteroids, and in patients who can not use Inhaled corticosteroids. In patients with the preparation in the form of tablets. 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. 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 montelukast; 1 tabl contains 10 mg of montelukast in the form of sodium montelukast. The preparation contains aspartame.
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 peak plasma concentration occurs after 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, the maximum concentration is reached after 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 the active substance or to any of the excipients.
Precautions:
It must 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 reduce the dose of oral corticosteroids during the concomitant use of montelukast. Because of 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 re-evaluated. There are no data on the use of the preparation in patients with severe hepatic impairment. In patients with asthma associated with hypersensitivity to Acetylsalicylic acid, despite the treatment with montelukast, Acetylsalicylic acid and other NSAIDs should be avoided. Montelukast is not recommended for children under 2 years of age. The preparation contains aspartame - it may be harmful for patients with phenylketonuria.
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 - abdominal pain and excessive thirst.Adverse reactions observed after marketing: upper respiratory tract infection, increased bleeding tendency, hypersensitivity reactions (including anaphylactic reactions, eosinophil infiltrates in the liver), sleep disorders (including nightmares), hallucinations, insomnia, somnabulizm, irritability, anxiety, anxiety (especially motor), agitation (including aggressive behavior or hostility), tremors, depression, very rarely suicidal thoughts and behaviors (suicidal tendencies), dizziness, drowsiness, paresthesia and / or hypoesthesia, convulsions, palpitations, nosebleeds, diarrhea, dry mouth, indigestion, nausea, vomiting, increased serum transaminases (ALAT, AST), hepatitis (including cholestatic hepatitis, inflammation of liver cells and liver damage with mixed etiology), edema vasomotor, bruising, urticaria, pruritus, rash, erythema nodosum, pains trauma, muscle pain (including muscle spasms), weakness and / or fatigue, malaise, swelling, fever. During treatment with montelukast, Churg-Strauss syndrome has been reported very rarely in asthmatic patients.
Dosage:
Orally. Adults and adolescents from 15 years with asthma or asthma and concurrent seasonal allergic rhinitis: 1 tablet. 10 mg once a day in the evening, regardless of meals. 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, in patients with renal insufficiency, and mild to moderate hepatic impairment. For patients aged 2-14 years with mild persistent asthma, if asthma control is satisfactory during treatment (usually within 1 month), an additional anti-inflammatory drug or drug change 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 that requires treatment with inhaled corticosteroids; the patient should be evaluated after 2-4 weeks of montelukast treatment, if a satisfactory response has not been achieved, additional or other treatment should be considered. The 10 mg dose can be added to the previously used treatment regimen. Table. chewing and chewing 4 mg and 5 mg can be chewed or swallowed; if tabl. to be swallowed, drink it with a sufficient amount of liquid (eg a glass of water). Table. 10 mg should be swallowed with a sufficient amount of liquid (eg a glass of water).
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