Montelar chewable pills 5mg N28
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Active ingredients
Montelukast
Release form
Pills
Composition
Montelukast sodium 5.2 mg, which corresponds to the content of montelukast 5 mg.; Excipients: mannitol - 194.9 mg, microcrystalline cellulose - 66 mg, croscarmellose sodium - 15 mg, hyprolosis (type EXF) - 9 mg, cherry flavoring - 2.4 mg (contains 0.07 % dye red charming Allura red AC (E129)), aspartame - 1.2 mg, cherry flavor additive - 0.6 mg, iron (III) dye red oxide - 0.45 mg, magnesium stearate - 5.25 mg.
Pharmacological effect
Antagonist of leukotriene receptors. Montelukast selectively inhibits CysLT1 receptors of cysteinyl leukotrienes (LTC4, LTD4, LTE4) of the respiratory tract epithelium, and also prevents bronchospasm in patients with bronchial asthma caused by inhalation of cysteinyl leukotriene LTD4. A dose of 5 mg is enough to relieve bronchospasm induced by LTD4. 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 ingestion and may complement the bronchodilation caused by beta2-adrenomimetics.
Pharmacokinetics
After oral administration, montelukast is rapidly and almost completely absorbed from the gastrointestinal tract. In adults, when taken in a dose of 5-10 mg Cmax in the blood plasma is achieved in 2-3 hours. Bioavailability when administered orally is 64-73%. Binding of montelukast to plasma proteins is more than 99%. Vd averages 8–11 l.; When taken once at a dose of 10 mg 1 time / day, a moderate (about 14%) cumulation of the active substance in plasma is observed.; Montelukast is actively metabolized in the liver. When used in therapeutic doses, the concentration of plasma metabolites of montelukast in an equilibrium state is not determined in adults and children. It is assumed that CYP3A4 and CYP2C9 isoenzymes are involved in the montelukast metabolism process, while the therapeutic concentrations of montelukast do not inhibit CYP3A4, 2C9, 2A2, 2A2, isoenzymes. , 2С19 and 2D6.; T1 / 2 montelukast in young healthy adults ranges from 2.7 to 5.5 hours. The clearance of montelukast in healthy adults averages 45 ml / min. After oral administration of montelukast, 86% is eliminated with feces within 5 days and less than 0.2% with urine, which confirms that montelukast and its metabolites are derived almost exclusively with bile.; Montelukast's pharmacokinetics remains almost linear when administered orally in doses of more than 50 mg.
Indications
Prevention and long-term treatment of bronchial asthma in children, including: Prevention of day and night symptoms of the disease (for children aged 2 years and older); Treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid (for children from 6 years and older); Prevention of bronchospasm caused by physical activity (for children aged 2 years and older); Relieving the symptoms of seasonal and year-round allergic rhinitis in children aged 2 years and older.
Contraindications
Hypersensitivity to any of the components of the drug.; Children's age up to 2 years (for a dosage of 4 mg) and up to 6 years (for a dosage of 5 mg) .; Phenylketonuria.
Use during pregnancy and lactation
Adequate and strictly controlled clinical studies of the safety of using Montelukast during pregnancy and lactation (breastfeeding) have not been conducted. It is not known whether montelukast is excreted in breast milk.; Montelukast should be used during pregnancy and during breastfeeding only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.
Dosage and administration
Inside, 1 time per day, before bedtime .; In the case of taking the drug in combination with food intake, montelukast should be taken 1 h before or 2 h after a meal .; The drug is prescribed to children under the supervision of adults .; For children from 2 to 5 years old - 1 chewable tablet at a dose of 4 mg 1 time per day, before bedtime (use of 4 mg mg montelukast chewable pills is not recommended before the age of 2 years); From 6 to 14 years old - 1 chewable tablet at a dose of 5 mg 1 time per day, before bedtime (the use of montelar chewable pills; 5 mg is not recommended before the age of 6 years). Therapeutic effect of montelukast develops within the 1st day of taking the drug. The patient should continue to take montelukast both in the period of achieving control of symptoms of bronchial asthma, and in periods of exacerbation of bronchial asthma .; For prevention in children suffering from bronchospasm caused by physical activity: from 2 to 5 years - 1 chewable tablet at a dose of 4 mg 1 time per day, before going to bed for 2-4 weeks; From 6 to 14 years old - 1 chewable tablet at a dose of 5 mg 1 time per day, before going to bed for 2-4 weeks. In the absence of a satisfactory effect, additional or alternative therapy should be prescribed .; For the treatment of patients older than 15 years and adults it is recommended to use other dosage forms of Montelukast (for example, film-coated pills,10 mg) .; For patients with renal insufficiency, mild or moderately impaired liver function, and also depending on gender, special dose selection is not required .; Montelukast is not recommended as monotherapy in patients with moderate-to-severe bronchial asthma.
Side effects
Infectious and parasitic diseases: upper respiratory tract infections. Violations of the blood and lymphatic system: increased tendency to bleeding, thrombocytopenia. Violations of the immune system: hypersensitivity reactions, including anaphylaxis, eosinophilic infiltration of the liver., Violations of the psyche: pathological dreams, including nightmares; hallucinations, insomnia, somnambulism, irritability, anxiety, anxiety; agitation, including aggressive behavior or hostility; tremor, depression, disorientation, suicidal thoughts and behavior (suicidality) .; Nervous system disorders: headache, dizziness, drowsiness, paresthesia / hypesthesia, convulsions.; Dysfunctions of the heart: feeling of palpitations.; Dysfunctions of the respiratory system, organs of the chest and mediastinum: nosebleeds. Violations of the gastrointestinal tract: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis. Violations of the liver and biliary tract: an increase in act alanine aminotransferase and aspartate aminotransferase, hepatitis (including cholestatic, hepatocellular and mixed lesions of the liver) .; Disorders of the skin and subcutaneous tissues: angioedema, tendency to hematomas, urticaria, pruritus, erythema nodosum, pruritus, hemorrhage, urticaria, pruritus, rash, nodular erythema, tendency to hematomas, urticaria, itching, rash, nodular erythema, multiform musculoskeletal and connective tissue: arthralgia, myalgia, including muscle cramps.; General disorders and disorders at the injection site: asthenia / fatigue, malaise, edema, pyrexia, thirst. In very rare cases, during the treatment with montelukast, the development of Chardzh-Stross syndrome was reported (see section Special Instructions).
Overdose
Currently, no cases of overdose have been reported.
Interaction with other drugs
With simultaneous use with phenobarbital, the AUC of Montelukast decreased by approximately 40% (correction of the montelukast regimen is not required) .; confirmation of the inhibition of CYP2C8 isoenzyme by montelukast has not been obtained. Therefore, in clinical practice, montelukast is not supposed to affect CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide.; Montelukast is a valid supplement to monotherapy with bronchodilators if the latter do not provide adequate control of asthma. Upon reaching the therapeutic effect of treatment with montelukast, you can begin a gradual reduction in the dose of bronchodilators. The use of montelukast provides an additional therapeutic effect in patients receiving inhaled GCS. Upon reaching stabilization, you can begin a gradual reduction in the dose of GCS under the supervision of a physician. In some cases, the complete abolition of inhaled GCS is permissible, however, abrupt replacement of inhaled corticosteroids with montelukast is not recommended.
special instructions
The effectiveness of montelukast for oral administration in relation to the treatment of acute attacks of bronchial asthma has not been established. Therefore, montelukast for oral administration is not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency medications for relief of bronchial asthma attacks (short-acting inhaled beta2-agonists). Do not stop taking montelukast during an exacerbation of asthma and the need for emergency medications (inhalation beta-2 short-acting); Patients with confirmed allergies to acetylsalicylic acid and other NSAIDs should not take these drugs during the period of treatment with montelukast, because montelukast in improving respiratory function in patients with allergic asthma, however, can not completely prevent NSAID-induced bronchoconstriction in them;. The dose of inhaled corticosteroids,used simultaneously with montelukast, can be gradually reduced under the supervision of a physician, however, abrupt replacement of inhalation or oral GCS with montelukast cannot be performed. Neuropsychiatric disorders have been described in patients taking montelukast. Considering that these symptoms could have been caused by other factors, it is not known whether they are associated with montelukast. The physician should discuss these side effects with patients and / or their parents / guardians. Patients and / or their caregivers need to be explained that if such symptoms occur, they should be reported to their attending physician. In rare cases, a reduction in the dose of systemic corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptors blockers, was accompanied by eosinophilia, rashes, worsening of pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as Chardz-Strauss syndrome, systemic eosinophilic vasculitis. Although the causal relationship between these adverse reactions and therapy with leukotriene receptor antagonists has not been established, caution should be exercised to reduce the dose of systemic corticosteroids in patients receiving montelukast; appropriate pediatric use should not be used in montelukast 2 years.; In children older than 2 years of montelukast should be used in the appropriate dosage form.