the product in the database has an inactive status
indications:
As an aid to the treatment of asthma in patients aged 15 years and older with mild or moderate chronic asthma, in whom treatment with inhaled glucocorticosteroids and "ad hoc" short-acting β-agonists does not adequately compensate for asthma symptoms. In patients with bronchial asthma who use the drug to treat asthma, it simultaneously relieves the symptoms of seasonal allergic rhinitis. The drug is also indicated in the prevention of asthma, in patients aged 15 years and older, in which the predominant symptom is exercise-induced bronchoconstriction.
Composition:
1 tabl powl. contains 10 mg of montelukast in the form of sodium montelukast. The drug contains 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. 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 sodium or to 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. No data available suggesting the possibility of reducing the dose of oral glucocorticosteroids during the concomitant use of montelukast. 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 and hypersensitivity to Acetylsalicylic acid, the use of Acetylsalicylic acid or other NSAIDs should still be avoided despite montelukast treatment. There are no data on the use of the drug in patients with severe hepatic impairment. The drug contains 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. 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.
Side effects:
Common: abdominal pain and headache. Adverse reactions observed after marketing: very common - upper respiratory tract infections; often - diarrhea, nausea, vomiting, increased activity of serum transaminases, urticaria, fever; uncommon - hypersensitivity reactions including anaphylaxis, sleep disorders, including nightmares, insomnia, sleepwalking, irritability, anxiety, agitation, including aggressive behavior or hostility, depression, dizziness, drowsiness, paresthesia, hypoesthesia, convulsions, bleeding with nose, dry mouth, indigestion, bruising, rash, pruritus, joint pain, muscle pain, including muscle spasms, weakness and / or fatigue, malaise, edema; rarely - increased bleeding tendency, tremor, palpitations, angioneurotic edema; very rarely - eosinophil infiltrates in the liver, hallucinations, confusion, suicidal thoughts and behaviors, Churg-Strauss syndrome, hepatitis (including cholestatic, hepatocellular carcinoma and liver damage with mixed etiology), erythema nodosum.
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. 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. The drug can be included in the previously used treatment regimen.
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