Composition
>of 1 tab. contains: Active ingredients: montelukast sodium is 5.2 mg, which corresponds to the content of montelukast 5 mg. Auxiliary substances: mannitol-201.35 mg, microcrystalline cellulose-63.45 mg, croscarmellose sodium-9 mg, hyprolose (hydroxypropylcellulose) – 9 mg, aspartame-1.5 mg, cherry flavor-4.5 mg, magnesium stearate-6 mg
Pharmacological action
Leukotriene receptor antagonist. Montelukast selectively inhibits CysLT1-receptors of cysteinyl leukotrienes (LTC4, LTD4, LTE4) of the respiratory tract epithelium, and also prevents bronchospasm caused by inhalation of cysteinyl leukotriene LTD4 in patients with bronchial asthma.
A dose of 5 mg is sufficient to relieve LTD4-induced bronchospasm. The use of montelukast in doses exceeding 10 mg 1 time/day does not increase the effectiveness of the drug.
Montelukast causes bronchodilation within 2 hours after oral use and may supplement the bronchodilation caused by beta-2-adrenomimetics.
Indications
Prevention and long-term treatment of bronchial asthma, including: prevention of day and night symptoms of the disease; treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid; prevention of exercise-induced bronchospasm.
Relief of day and night symptoms of seasonal allergic rhinitis.
Contraindications
Children under 2 years of age, hypersensitivity to montelukast.
Side effects
from the blood coagulation system: Â increased tendency to bleed.
From the immune system: Â hypersensitivity reactions, including anaphylaxis; very rare (
From the side of the psyche: Â agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, abnormal dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and behavior( suicidality), tremor.
Nervous system disorders: Â dizziness, drowsiness, paresthesia/hypesthesia; very rare (
From the cardiovascular system: Â tachycardia.
Respiratory system disorders: Â nosebleeds, upper respiratory tract infections.
From the digestive system: Â diarrhea, dyspepsia, nausea, vomiting, pancreatitis, increased ALT and ACT activity in the blood; very rare (
Skin and subcutaneous tissue disorders: Â tendency to form hematomas, erythema nodosum, erythema multiforme, pruritus, rash.
Allergic reactions: Â angioedema, urticaria.
Musculoskeletal disorders: Â arthralgia, myalgia, including muscle cramps.
From the body as a whole: Â asthenia (weakness)/fatigue, swelling, pyrexia.
Interaction
When used concomitantly with phenobarbital, the AUC of montelukast decreased by approximately 40% (correction of the montelukast regimen is not required).
In vitro studies have shown that montelukast inhibits the CYP2C8 isoenzyme, but the study of the in vivo drug interaction between montelukast and rosiglitazone (metabolized with the participation of the CYP2C8 isoenzyme ) did not confirm the inhibition of the CYP2C8 isoenzyme by montelukast. Therefore, in clinical practice, montelukast is not expected to affect the CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, and repaglinide.
Montelukast is a reasonable adjunct to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. After achieving the therapeutic effect of treatment with montelukast, you can start gradually reducing the dose of bronchodilators.
The use of montelukast provides an additional therapeutic effect in patients receiving inhaled corticosteroids. When the condition is stabilized, you can start gradually reducing the dose of corticosteroids under the supervision of a doctor. In some cases, complete withdrawal of inhaled corticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with montelukast is not recommended.
How to take, course of use and dosage
The dose is set individually, depending on the age, indications and dosage form used. Take orally at a dose of 4-10 mg 1 time/day.
The therapeutic effect of montelukast on indicators reflecting the course of bronchial asthma develops during the first day. You should continue taking montelukast both during the period of achieving control of symptoms of bronchial asthma, and during the period of exacerbation of the disease.
Monteluxt can be added to treatment with bronchodilators and inhaled corticosteroids.
Special instructions
The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, montelukast for oral use is not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency medications for managing asthma attacks (short-acting inhaled beta-2agonists).
Do not stop taking montelukast during the period of acute asthma and the need to use emergency medications (short-acting inhaled beta-2agonists) to stop seizures.
Patients with confirmed allergies to acetylsalicylic acid and other NSAIDs should not take these medications during treatment with montelukast, since montelukast, while improving respiratory function in patients with allergic bronchial asthma, cannot completely prevent their NSAID-induced bronchoconstriction.
The dose of inhaled corticosteroids used simultaneously with montelukast can be gradually reduced under the supervision of a doctor, but a sharp replacement of inhaled or oral corticosteroids with montelukast should not be carried out.
Neuropsychiatric disorders have been reported in patients treated with montelukast. Given that these symptoms may have been caused by other factors, it is not known whether they are related to taking montelukast. The doctor should discuss these side effects with patients and/or their parents / guardians. Patients and/or their caregivers should be advised that if such symptoms occur, they should inform the attending physician.
Reducing the dose of systemic corticosteroids in patients receiving anti-asthmatic agents, including leukotriene receptor blockers, was accompanied in rare cases by one or more of the following reactions: eosinophilia, rashes, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Charge-Strauss syndrome, systemic eosinophilic vasculitis. Although the causal relationship of these adverse reactions with leukotriene receptor antagonist therapy has not been established, caution should be exercised and appropriate clinical monitoring should be carried out when reducing the dose of systemic corticosteroids in patients receiving montelukast.
Use in pediatrics
Montelukast should not be used in children under 2 years of age.
In children over 2 years of age, montelukast should be used in the appropriate dosage form.
Active ingredient
Montelukast
Conditions of release from pharmacies
By prescription
Dosage Form
Chewable tablets
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Side effects of Glemont Chewable tablets 4mg, 28pcs.
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