Montelar - instructions for use, analogs, testimonials and release forms (10 mg tablets, chewing 4 mg and 5 mg) of the drug for the treatment and prevention of bronchial asthma, as well as attacks in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Montelar. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Montelar in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Montelar with available structural analogues. Use for the treatment and prevention of bronchial asthma, as well as attacks in adults, children, as well as in pregnancy and lactation. Composition of the preparation.

Montelar antagonist of leukotriene receptors. Montelukast (active ingredient of the preparation Montelar) selectively inhibits CysLT1 receptors of cysteinyl leukotrienes (LTC4, LTD4, LTE4) respiratory 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 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.

Montelar causes bronchodilation in 2 hours after ingestion and can supplement the bronchodilation caused by beta2-adrenomimetics.

Composition

Montelukast + auxiliary substances.

Pharmacokinetics

After oral administration, Montelar is quickly and almost completely absorbed from the digestive tract. Bioavailability with oral administration is 64-73%. The binding of montelukast to plasma proteins is more than 99%. With a single dose of 10 mg once a day, moderate (about 14%) cumulation of the active substance in the plasma. 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 CYP3A4 and CYP2C9 are involved in the metabolism of montelukast, while in therapeutic concentrations, montelukast does not inhibit the isoenzymes CYP3A4, 2C9, 1A2, 2A6, 2C19 and 2D6. After oral administration, 86% is excreted with feces for 5 days and less than 0.2% with urine, which is confirmed by the fact that montelukast and its metabolites are excreted almost exclusively with bile.

Indications

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.

Cupping of day and night symptoms of seasonal allergic rhinitis.

Forms of release

The tablets covered with a cover of 10 mg.

Tablets chewing 4 mg and 5 mg.

Instructions for use and reception scheme

Inside, 1 time per day, before bedtime.

In case of taking the drug in combination with eating, Montelar should be taken 1 hour before or 2 hours after eating.

The drug is administered to children under adult supervision.

For children from 2 to 5 years - 1 chewing tablet in a dose of 4 mg once a day,before bedtime (the use of Montelar chewable tablets of 4 mg is not recommended until the age of 2 years); from 6 to 14 years - 1 chewable tablet in a dose of 5 mg once a day, before bedtime (the use of chewable tablets Montelar 5 mg is not recommended until the age of 6 years). The therapeutic effect of montelukast develops during the first day of taking the drug. The patient should continue to take montelukast both during the control period of symptoms of bronchial asthma, and during periods of exacerbation of bronchial asthma.

For prophylaxis in children suffering from bronchospasm caused by physical exertion: from 2 to 5 years - 1 chewing tablet at a dose of 4 mg once a day, before going to bed for 2-4 weeks; from 6 to 14 years - 1 chewable tablet in 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.

To treat patients older than 15 years and adults, it is recommended to use 10 mg tablets.

For patients with renal insufficiency, mild or moderate liver function disorders, and also depending on sex, no special dose selection is required.

Montelar is not recommended as a monotherapy for patients with moderate to severe bronchial asthma.

Side effect

• increased tendency to bleeding;
• hypersensitivity reactions, incl. anaphylaxis;
• eosinophilic liver infiltration;
• agitation (including aggressive behavior or hostility);
• anxiety;
• depression;
• disorientation;
• pathological dreams;
• hallucinations;
• insomnia;
• irritability;
• anxiety;
• somnambulism;
• suicidal thoughts and behavior (suicidal);
• tremor;
• dizziness;
• drowsiness;
• paresthesia / hypoesthesia;
• convulsions;
• tachycardia;
• nasal bleeding;
• upper respiratory tract infection;
• diarrhea;
• dyspepsia;
• nausea, vomiting;
• pancreatitis;
• increased activity of ALT and ACT in the blood;
• Hepatitis (including cholestatic, hepatocellular and mixed liver damage);
• propensity to form hematomas;
• erythema nodosum;
• erythema multiforme;
• itching;
• rash;
• angioedema;
• hives;
• arthralgia;
• Myalgia, including muscle cramps;
• weakness;
• fatigue;
• edema.

Contraindications

• children under 2 years;
• increased sensitivity to montelukastu.

Application in pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of use of Montelar during pregnancy and lactation (breastfeeding) were not conducted. It is not known whether Montelar is excreted in breast milk.

Montelar should be used during pregnancy and during breastfeeding only when the expected benefit to the mother exceeds the potential risk to the fetus or child.

Use in children

The safety and efficacy of Montelar in children with bronchial asthma from 6 to 14 years are well studied in controlled clinical trials. Profiles of safety and efficacy are similar in this group of patients and in adults.

Based on the conducted controlled clinical studies in children 6 years and older with bronchial asthma, a conclusion was made about the safety of Montelar chewing tablets at a dose of 4 mg in children from 2 to 5 years with bronchial asthma. The evidence for the extrapolation was evidence of the similarity of the pharmacokinetics of montelukast in these patient groups. It also took into account the assumption that the pathophysiological mechanisms, the course of the disease,the response to drug therapy is essentially similar in the group of children 2-5 years old and in patients 6 years and older.

special instructions

The effectiveness of Montelar for oral administration with respect 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 have emergency medications to stop asthma attacks (short-acting inhaled beta2-agonists).

You should not stop taking Montelar during an exacerbation of asthma and the need to use emergency medications (short-acting inhaled beta2-agonists) for relief of attacks.

Patients with a confirmed allergy to Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) should not take these drugs during treatment with montelukast, since montelukast, improving respiratory function in patients with allergic bronchial asthma, can not completely prevent the NSAID caused by them bronchoconstriction.

The dose of inhaled glucocorticosteroids (GCS), used in conjunction with montelukast, you can gradually reduce under supervision of a physician, but the sharp replacement of inhaled or oral corticosteroids montelukast should not be carried out.

Does not contain hormones and hormone-like agents in its composition.

Psychoneurological disorders have been described in patients taking montelukast. Given that these symptoms could be caused by other factors, it is not known whether they are associated with taking 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 in case of such symptoms it is necessary to inform the attending physician about it.

Decreasing doses of systemic corticosteroids in patients receiving antiasthmatics including blockers of leukotriene receptors, followed in rare cases the appearance of one or more of the following reactions: eosinophilia, rash, worsening pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as a Chardzhev-Strauss syndrome, systemic eosinophilic vasculitis.Although there was no causal relationship between these adverse events and therapy with leukotriene receptor antagonists, caution should be exercised while appropriate clinical monitoring is performed when the dose of systemic GCS is reduced in patients receiving montelukast.

In children older than 2 years, montelukast should be used in the appropriate dosage form.

Drug Interactions

With simultaneous application with Phenobarbital AUC, montelukast decreased by approximately 40% (correction of the Montelukast regimen is not required).

Montelar is a justified addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. When the therapeutic effect is achieved from the treatment with montelukast, a gradual reduction in the dose of bronchodilators can be started.

The use of montelukast provides an additional therapeutic effect in patients receiving inhaled glucocorticosteroids. Once the state stabilizes, a gradual reduction in the dose of GCS can be started under the supervision of a physician. In some cases, complete cancellation of inhaled glucocorticosteroids is permissible, but a sharp substitution of inhaled corticosteroids for montelukast is not recommended.

Analogues of the medicinal product Montelar

Structural analogs for the active substance:

• Almonte;
• Monax;
• Moncast;
• The Montler;
• Montelast;
• Montelukast;
• Montelukast sodium;
• Simpler;
• Singlon;
• Singulex;
• Singular;
• Ektalust.

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