Montelar tabs 4mg #28

Instruction for Montelar

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Montelar is an anti-inflammatory anti-bronchoconstrictor drug for the treatment of bronchial asthma and allergic rhinitis.

Release form and composition

Dosage forms of Montelar:
    chewable tablets: pink, with numerous impregnations of a darker color, with a characteristic smell of cherries; engraved “4” on one side in a dosage of 4 mg, “5” in a dosage of 5 mg (in a blister 7 pcs., in a cardboard box 1, 2, 3, 4, 8 or 10 blisters; in a blister 10 or 14 pcs. ., in a cardboard box 1, 2, 3, 4, 5 or 7 blisters).
Composition of one Montelar chewable tablet:
    active substance: montelukast - 4 or 5 mg (in the form of montelukast sodium - 4.16 or 5.2 mg, respectively);
    auxiliary components: mannitol, microcrystalline cellulose, croscarmellose sodium, hyprolose (EXF type), cherry flavor (contains charming red dye Allura Red AC), cherry flavoring, aspartame, dye red iron oxide III, magnesium stearate.

Pharmacodynamics

Montelukast sodium blocks CysLT1 - cysteine ​​leukotriene receptors of the epithelium of the respiratory tract (leukotrienes LTC4, LTD4 and LTE4), which are mediators of persistent chronic inflammation and are involved in the pathogenesis of bronchial asthma, contributing to an increase in bronchial hyperreactivity.
Preventing excessive mucus formation in the bronchi, montelukast reduces the likelihood of swelling of the mucous membrane of the respiratory tract, eases the severity of bronchial asthma and reduces the frequency of asthmatic attacks.
The bronchodilator effect of the drug develops within one day and persists for a long time. The dose of montelukast 5 mg, taken orally, is able to stop the bronchospasm induced by LTD4. Taking the drug in doses exceeding 10 mg / day does not increase its effectiveness.
Montelar causes bronchodilation within two hours after oral administration, in combination with montelukast and beta2-adrenergic agonists, a synergistic bronchodilating effect may develop.

Pharmacokinetics

Montelukast sodium after oral administration is absorbed in the gastrointestinal tract quickly and almost completely. The maximum concentration (Cmax) in plasma in adults after taking a dose of 5-10 mg is achieved after 2-3 hours. Oral bioavailability ranges from 64 to 73%.
More than 99% of the active substance binds to plasma proteins. Distribution volume (Vd) averages 8–11 liters.
With a single dose of montelukast 10 mg / day, moderate (approximately 14%) cumulation of the substance in the blood plasma is noted.
Montelukast sodium is actively metabolized in the liver. The concentration of its metabolites in blood plasma when using therapeutic doses of Montelar in an equilibrium state in patients of any age groups is not determined. In all likelihood, the montelukast metabolism process occurs with the participation of CYP2C9 and CYP3A4 isoenzymes, while at therapeutic concentrations it does not suppress CYP3A4, 1A2, 2A6, 2C9, 2D6 and 2C19 isoenzymes.
In healthy young adult volunteers, the half-life (T1 / 2) of montelukast is in the range from 2.7 to 5.5 hours, the clearance of the active substance is on average 45 ml / min. After oral administration, montelukast sodium and its metabolites are excreted almost exclusively with bile. 86% of the substance is excreted through the intestine within 5 days, through the kidneys - less than 0.2%.
With oral administration of doses above 50 mg, the pharmacokinetic parameters of montelukast remain virtually linear.

Indications for use

    bronchial asthma - for prevention and long-term treatment (including the prevention of day and night symptoms of the disease, the prevention of physical exertion of bronchospasm, therapy of the disease in patients with hypersensitivity to acetylsalicylic acid);
    seasonal allergic rhinitis - for relief of day and night symptoms.

Contraindications

    children under 2 years old (for Montelar tablets 4 mg), up to 6 years (for 5 mg tablets), up to 15 years (for 10 mg tablets);
    increased individual sensitivity to montelukast and / or any auxiliary component of the drug.
The use of Montelar during pregnancy and during breastfeeding requires caution.

Instructions for use Montelar: method and dosage

Montelar tablets are taken orally, 1 hour before or 2 hours after a meal. It is preferable to take the drug once a day before bedtime.
The dose for each patient is set individually, taking into account the age, indications and dosage form of the drug. It is recommended to take from 4 to 10 mg of montelukast once a day.
The therapeutic effect of Montelar on the course of bronchial asthma develops during the first day. It is necessary to continue taking pills both during the period of achieving control of the symptoms of the disease, and during exacerbation of bronchial asthma.
Montelar can be used in combination therapy with bronchodilators and inhaled glucocorticosteroids.

Side effects

Possible side effects from systems and organs:
    nervous system: drowsiness, dizziness, hypesthesia, paresthesia; very rarely (less than 0.01%) - convulsions;
    psyche: anxiety, anxiety, irritability, insomnia, tremor, depression, pathological dreams, agitation (including hostility or aggressive behavior), hallucinations, somnambulism, disorientation, suicidality (suicidal thoughts and behavior);
    cardiovascular system: tachycardia;
    digestive system: nausea, vomiting, diarrhea, dyspepsia, pancreatitis, increased activity of alanine aminotransferase and aspartate aminotransferase in the blood; very rarely - hepatitis (including hepatocellular, cholestatic and mixed liver lesions);
    immune system: hypersensitivity reactions, including anaphylaxis; very rarely - eosinophilic liver infiltration;
    blood coagulation system: an increase in bleeding tendency;
    respiratory system: upper respiratory tract infections, nosebleeds;
    skin and subcutaneous tissues: itching, rash, tendency to form hematomas, erythema nodosum, exudative erythema;
    allergic reactions: urticaria, angioedema;
    musculoskeletal system: myalgia (including muscle cramps), arthralgia;
    body as a whole: fatigue, weakness (asthenia), edema, pyrexia.

Overdose

Experimental studies have not revealed data on the manifestations of an overdose of montelukast in patients with bronchial asthma with an oral dose of more than 200 mg / day for 22 weeks and a dose of 900 mg / day for 1 week.
There are reports of acute overdose of the drug in children when ingested at least 1000 mg of montelukast per day. At the same time, clinical and laboratory indicators indicate that the safety profile of montelukast in children corresponds to that in adults and elderly patients.
In case of an overdose, the most common symptoms were thirst, headache, vomiting, abdominal pain, drowsiness, mydriasis, psychomotor agitation, and hyperkinesis.
In such cases, symptomatic treatment is recommended.
There is no information on the feasibility of removing montelukast using the procedure of peritoneal dialysis or hemodialysis.

special instructions

Since the effectiveness of Montelukast oral administration in relation to the relief of acute attacks of bronchial asthma has not been established, it is not recommended to use Montelar in such cases. Patients should be informed of the need to always have with them the means of emergency relief of acute attacks of bronchial asthma (inhaled short-acting beta2-adrenergic agonists).
In the period of exacerbation of the disease and the need to use short-acting inhaled beta2-agonists to stop asthma attacks, Montelar should not be stopped.
It is not recommended to take acetylsalicylic acid and other non-steroidal anti-inflammatory drugs during montelukast treatment for patients with confirmed hypersensitivity to these drugs, since Montelar, by improving respiratory function in patients with allergic bronchial asthma, cannot prevent bronchoconstriction completely caused by allergens.
The dose of inhaled glucocorticosteroids used in conjunction with montelukast can gradually be reduced, but under medical supervision. Montelar cannot abruptly replace oral or inhaled glucocorticosteroids.
In rare cases, a decrease in the dose of systemic glucocorticosteroids in patients taking anti-asthma drugs (including leukotriene receptor blockers) was accompanied by a rash, eosinophilia, worsening pulmonary symptoms, cardiological complications and / or neuropathy, sometimes diagnosed as Charge-Strauss syndrome, systemic eosinophilic. Although a causal relationship between these side effects and the use of leukotriene receptor antagonists has not been established, care must be taken to ensure appropriate clinical observation while reducing the dose of systemic glucocorticosteroids in patients taking montelukast.
Cases of neuropsychiatric disorders in the treatment of Montelar are described. Since these symptoms could have been caused by other causes, it is not known whether they are associated with the use of montelukast. The attending physician should discuss these side effects with the patient and / or his parents or guardians and explain the need to notify the doctor if such symptoms occur.

Influence on the ability to drive vehicles and complex mechanisms

During treatment with montelukast, drowsiness and dizziness were reported, therefore, in the event of these signs, driving vehicles and performing work requiring a fast motor / mental response and a high concentration of attention is not recommended.

Pregnancy and lactation

Reliable data on the safety of Montelukast during pregnancy and lactation are not available. There is no information whether the drug passes into breast milk.
According to the instructions, Montelar should be prescribed to pregnant and lactating women only if the expected benefit to the mother is higher than the potential risk to the fetus / baby.

Use in childhood

The use of Montelar in children under 2 years of age is contraindicated.

Drug interaction

    phenobarbital: a decrease in the area under the pharmacokinetic curve (AUC) of montelukast is possible by approximately 40%. Montelukast dosage adjustment is not required;
    paclitaxel, rosiglitazone, repaglinide, and other drugs metabolized with the participation of the CYP2C8 isoenzyme: in clinical practice, the effect of montelukast on their CYP2C8-mediated metabolism is not expected, since there is no evidence of inhibition by montelukast of this isoenzyme;
    bronchodilators: their combination with montelukast is justified in cases where monotherapy with bronchodilators does not provide the necessary control of symptoms of bronchial asthma. After the therapeutic effect of the use of montelukast is achieved, doses of bronchodilators can be gradually reduced;
    inhaled glucocorticosteroids: the use of montelukast provides an additional therapeutic effect. When stabilization is achieved under the supervision of a doctor, you can begin to gradually reduce the dose of glucocorticosteroids. In some cases, their complete cancellation is permissible, however, a sharp replacement with inhaled glucocorticosteroids by montelukast is not recommended.

Terms and conditions of storage

Store in a place protected from moisture and light, at a temperature not exceeding 30 ° C.
Keep out of the reach of children.
Shelf life is 2 years.

Reviews

Reviews about Montelar indicate the effectiveness of the drug in the treatment of allergic bronchial asthma in children and adults. Users note that in order to achieve a therapeutic effect, the drug must be taken systematically, strictly observing the dosage regimen recommended by the doctor.
In rare cases, patients report a side effect such as insomnia.

Terms of sell

You don't need a prescription to buy Montelar.