Active substanceMontelukastMontelukast
Similar drugsTo uncover
  • Almonte
    pills inwards 
  • Almonte
    pills inwards 
  • Glemont
    pills inwards 
  • Monax®
    pills inwards 
  • Monax®
    pills inwards 
  • Moncasta®
    pills inwards 
    KRKA-RUS, LLC     Russia
  • Moncasta®
    pills inwards 
    KRKA-RUS, LLC     Russia
  • Montler®
    pills inwards 
  • Montler®
    pills inwards 
  • Montelar
    pills inwards 
    Sandoz d.     Slovenia
  • Montelar
    pills inwards 
    Sandoz d.     Slovenia
  • Montelukast
    pills inwards 
    VERTEKS, AO     Russia
  • Montelukast
    pills inwards 
    VERTEKS, AO     Russia
  • Montelukast
    pills inwards 
  • Montelukast
    pills inwards 
  • Montelukast
    pills inwards 
  • Singlon®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Singlon®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Singlon®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Singular®
    pills inwards 
    Merck Sharp and Doum B.V.     Netherlands
  • Singular®
    pills inwards 
    Merck Sharp and Doum B.V.     Netherlands
  • Singular®
    pills inwards 
    Merck Sharp and Doum B.V.     Netherlands
  • Ektalust®
    pills inwards 
  • Ektalust®
    pills inwards 
  • Dosage form: & nbspTfilm-covered abeys.
    Composition:

    Each film-coated tablet contains:

    Active substance: montelukast -10.00 mg (in the form of montelukast sodium-10.40 mg);

    Excipients:

    core: micro-lacquer 100 (lactose monohydrate 75.00%, microcrystalline cellulose - 25,0%) -173,92 mg, croscarmellose sodium - 5,20 mg, giprolose - 8.32 mg, magnesium stearate - 4.16 mg;

    film sheath: Opavray AMV® (polyvinyl alcohol 45.52%, titanium dioxide 31.11%, talc 20.00%, soy lecithin 2.00%, xanthan gum 0.48%, iron oxide oxide yellow 0, 84%, iron dye oxide red - 0.05%) - 6.0 mg.

    Description:

    Square, with rounded corners biconvex tablets of beige color, covered with a film shell.

    Pharmacotherapeutic group:anti-inflammatory anti-bronchoconstrictive agent - leukotriene receptor blocker
    ATX: & nbsp

    R.03.D.C.03   Montelukast

    Pharmacodynamics:

    A leukotriene receptor antagonist. Montelukast inhibits cysteinyl leukotriene receptors of the respiratory epithelium, while exhibiting the ability to inhibit bronchospasm due to the inhalation of cysteinyl leukotriene LTD4 in patients with bronchial asthma. Doses 5 mg is sufficient to stop the bronchospasm induced by LTD4. The use of montelukast in doses exceeding 10 mg once a day does not improve the effectiveness of the drug. Bronchodilator effect develops within 1 day and can complement the bronchodilation induced by beta2-adrenomimetics.

    Pharmacokinetics:

    Suction: After oral administration montelukast quickly absorbed. Average the maximum concentration in plasma (CmOh) after taking an empty tablet 10 mg, film-coated, was achieved after three hours (TmOh). The average oral bioavailability is 64%. Reception of usual food does not affect FROMmOh in blood plasma and bioavailability of the drug.

    Distribution: Montelukast binds to plasma proteins more than 99%. The volume of distribution in a state of stable equilibrium averages 8-11 liters.

    Metabolism: Montelukast is actively metabolized in the liver.When used in therapeutic doses, the concentration of metabolites of montelukast in plasma in an equilibrium state in adults and children is not determined.

    It is assumed that the isoenzymes of cytochrome P450 (3A4 and 2C9) are involved in the metabolism of montelukast, while in therapeutic concentrations montelukast does not inhibit isoenzymes CYP: 3A4.2C9, 1A2.2A6.2C19 and 2D6.

    Excretion: The clearance of montelukast is 45 ml / min in healthy adults. The half-life (T1/2) montelukast in young healthy adults is from 2.7 to 5.5 h. After taking montelukast inside 86% of the dose is excreted through the intestine for 5 days, and less than 0.2% - kidneys, which confirms that montelukast and its metabolites are excreted almost exclusively through the intestine.

    When taking montelukast in the morning and evening hours, there is no difference in pharmacokinetics.

    Indications:

    1. Prophylaxis 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;

    - the prevention of bronchospasm, caused by physical exertion.

    2.Relief of seasonal and allergic rhinitis symptoms.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - children's age till 15 years;

    - soy intolerance, rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption (because the drug contains lactose).

    Carefully:

    During pregnancy and breastfeeding.

    Pregnancy and lactation:

    The drug should be used during pregnancy and during breastfeeding only in cases where the expected benefit for the mother exceeds the potential risk to the fetus or child.

    Dosing and Administration:Inside.
    Adults and children over 15 years of age - 1 tablet of 10 mg once a day, regardless of food intake.

    For treatment of bronchial asthma the drug should be taken in the evening.

    When treatment of allergic rhinitis the drug can be taken at any time of the day.

    The therapeutic effect of the drug on the indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take MONAX® both during the control period of symptoms of bronchial asthma and during the period of exacerbation of the disease.

    For the prevention of bronchospasm, caused by physical exertion in children older than 15 years and adults: 1 tablet 10 mg once a day, before going to bed for 2-4 weeks, in the absence of a satisfactory effect, additional or alternative therapy should be prescribed.

    Montelukast is not recommended as a monotherapy for patients suffering from moderate bronchial asthma.

    For elderly patients, patients with renal insufficiency, patients with mild or moderate hepatic impairment special selection of the dose is not required.

    MONAX® can be added to treatment with bronchodilators and inhaled glucocorticosteroids (GCS).

    Side effects:

    Frequency of adverse effects: very often (≥ 10%), often (≥ 1%, but <10%), infrequently (≥ 0.1% but <1%), rarely (≥ 0.01%, but <0.1%), very rarely (<0.01%), including individual reports.

    Immune system disorders: very rarely - reactions hypersensitivity, including anaphylaxis, angioedema, eosinophilic liver infiltrates.

    Violations of the blood and lymphatic system: very rarely - increased bleeding, a tendency to form a hematoma, thrombocytopenia.

    Disturbances from the nervous system: often - headache; very rarely - drowsiness, paresthesia / hypoesthesia, convulsions, tremor, dizziness, sleep disturbance, asthenia / fatigue.

    Disorders of the psyche: often fatigue; very rarely - excitability, aggressive behavior, anxiety, abnormal dreams, hallucinations, depression, insomnia, irritability, suicidal thinking and behavior, somnambulism.

    Heart Disease: very rarely - a feeling of palpitations.

    Disorders from the gastrointestinal tract: often - abdominal pain, diarrhea, dyspepsia, nausea; very rarely - vomiting, pancreatitis, dry mouth.

    Disturbances from the liver and bile ducts: rarely - cholestatic hepatitis, damage to hepatocytes on the background of drug therapy or concomitant liver pathology (alcohol and other forms of hepatitis), increased activity of "liver" transaminases.

    Disturbances of musculoskeletal and connective tissue: very rarely - arthralgia, myalgia, including muscle cramps.

    Respiratory system disorders: rarely - pharyngitis, infections of the upper respiratory tract, cough, sinusitis, otitis media (incl.middle), rhinorrhea, flu-like syndrome, epistaxis.

    Disturbances from the skin and subcutaneous tissues: often - hives, rash; very rarely - nodular erythema, itching.

    General disorders: often - thirst; rarely - malaise, swelling, hyperthermia.

    In general, the drug is well tolerated. Side effects are usually mild and, as a rule, do not require withdrawal of treatment.

    Overdose:

    In case of acute overdose of montelukast (intake of at least 1000 mg per day), the most frequent side effects were: thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain, mydriasis, hyperkinesia.

    Treatment: gastric lavage, symptomatic therapy.

    Data on the effectiveness of peritoneal dialysis or hemodialysis Montelukast no.

    Interaction:

    The drug can be prescribed together with other medications traditionally used for the prevention and long-term treatment of bronchial asthma.

    Montelukast at the recommended therapeutic dose did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35/1), terfenadine, digoxin and warfarin.

    Because the montelukast is metabolized by the CYP 3A4 isoenzyme, caution should be used especially in children, if montelukast concomitantly administered with preparations inducing the CYP 3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.

    Phenobarbital accelerates the metabolism of Montelukast in the liver. With simultaneous appointment of patients with phenobarbital and montelukast, the area under the concentration-time curve (AUC) decreased by approximately 40%. However, dose adjustment is not required.

    Combined treatment with bronchodilators:

    If the bronchodilators are ineffective, mona therapy of bronchial asthma can be supplemented with MONAX®. When the therapeutic effect is achieved (usually after the first dose), the dose of bronchodilators can be gradually reduced against the background of therapy with montelukast.

    Combined treatment with inhaled glucocorticosteroids:

    The use of montelukast provides an additional therapeutic effect in patients receiving inhaled glucocorticosteroids. At achievement of stabilization of a status of the patient reduction of a dose of GCS is possible. The dose of GCS should be reduced gradually, under the supervision of a doctor.In some cases, the intake of inhaled glucocorticosteroids can be reversed completely. However, a sharp substitution of inhaled glucocorticosteroids for montelukast Not recommended.

    Special instructions:

    The drug is not recommended for the treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma, patients should be prescribed medications for conduction and prevention of seizure therapy.

    Treatment with Montelukast does not guarantee absolute prevention of exacerbations, therefore it is recommended that patients with bronchial asthma always have emergency medications. In the event of an acute attack of bronchial asthma, an inhaled beta-agonist of rapid action should be used.

    The dose of inhaled glucocorticosteroids used simultaneously with oral montelukast should be reduced gradually under the supervision of a physician. A sharp substitution of inhaled or oral GCS with MONAX® is inadmissible.

    In patients with aspirin asthma, treatment with montelukast does not negate the need to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.

    A decrease in the systemic dose of GCS in patients receiving antiasthmatic drugs, including leukotriene receptor antagonists, was accompanied in rare cases by the development of the Charge-Strauss syndrome (systemic eosinophilic vasculitis) manifested as one or more of the following symptoms: eosinophilia, vascular rash, exacerbation of symptoms from the side lung, cardiac complications and / or neuropathy. Although the causal relationship of these adverse events with therapy of leukotriene receptor antagonists has not been established, with a reduction in the systemic dose of GCS in patients taking montelukast, care must be taken to ensure appropriate medical supervision.

    Age differences in the efficacy and safety of montelukast were not revealed.

    Effect on the ability to drive transp. cf. and fur:

    Montelukast does not affect the ability to drive and other mechanisms. However, in very rare cases, some patients experienced drowsiness and dizziness. In this case, patients are not recommended as driving a vehicle, or engaging in other activities,requiring concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets, film-coated, 10 mg.
    Packaging:

    For 14 tablets in a blister of Al / Al.

    For 2 or 6 blisters in a cardboard pack together with instructions for use.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001922
    Date of registration:06.12.2012 / 13.04.2016
    Expiration Date:06.12.2017
    The owner of the registration certificate:Zentiva Saalyk Yuryunleri Sanayi ve Tidjaret A.Sh.Zentiva Saalyk Yuryunleri Sanayi ve Tidjaret A.Sh. Turkey
    Manufacturer: & nbsp
    Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC
    Information update date: & nbsp04.10.2016
    Illustrated instructions
      Instructions
      Up