Montelar - Instructions For Use, Price, Reviews, 4 Mg Tablets, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Montelar

Montelar: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Montelair

ATX code: R03DC03

Active ingredient: montelukast (montelukast)

Producer: SANDOZ ILAC SANAYI VE TICARET (Turkey)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 310 rubles.

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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:

• film-coated tablets: biconvex, rectangular, with rounded edges, beige, engraved with "10" on one side; at the break have the appearance of a homogeneous mass of white color (in a blister 7 pcs., in a cardboard box 1, 2, 3, 4, 8, 10 or 14 blisters; in a blister 10 pcs., in a cardboard box 1, 2, 3, 4 or 7 blisters; in a blister 14 pcs., In a cardboard box 1, 2, 3, 4, 5 or 7 blisters);
• chewable tablets: pink, with numerous blotches of a darker color, with a characteristic cherry smell; “4” is engraved on one side at a dosage of 4 mg, at a dosage of 5 mg - “5” (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).

The composition of one tablet, film-coated, Montelar:

• active substance: montelukast - 10 mg (in the form of montelukast sodium - 10.4 mg);
• auxiliary components (core): lactose monohydrate, hyprolose (type EF), microcrystalline cellulose, croscarmellose sodium, magnesium stearate;
• shell: beige opadry (hypromellose, titanium dioxide, macrogol 400, yellow iron oxide III dye, red iron III oxide dye).

The composition of one chewable tablet Montelar:

• 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 Allura Red AC dye), cherry flavor, aspartame, red iron oxide III dye, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Montelukast sodium blocks CysLT1 - cysteine leukotriene receptors of the airway epithelium (leukotrienes LTC4, LTD4 and LTE4), which are mediators of persistent chronic inflammation and are involved in the pathogenesis of bronchial asthma, contributing to increased bronchial hyperreactivity.

By preventing excess mucus production in the bronchi, montelukast reduces the likelihood of swelling of the mucous membrane of the respiratory tract, alleviates 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. A dose of 5 mg montelukast taken orally is capable of arresting the LTD4-induced bronchospasm. Taking the drug in doses exceeding 10 mg / day does not increase its effectiveness.

Within two hours after oral administration, Montelar causes bronchodilation; in combination with montelukast with beta ₂ -adrenomimetics, a synergistic bronchodilatory effect can develop.

Pharmacokinetics

Montelukast sodium after oral administration is absorbed in the gastrointestinal tract quickly and almost completely. The maximum concentration (C _max) in the blood plasma in adults after taking a dose of 5-10 mg is achieved in 2-3 hours. Oral bioavailability ranges from 64 to 73%.

More than 99% of the active substance binds to blood plasma proteins. The volume of distribution (V _d) averages 8–11 liters.

With a single dose of montelukast 10 mg / day, there is a moderate (approximately 14%) accumulation of the substance in the blood plasma.

Montelukast sodium is extensively metabolized in the liver. The concentration of its metabolites in the blood plasma when using therapeutic doses of Montelar in an equilibrium state in patients of any age group is not determined. In all likelihood, the metabolic process of montelukast occurs with the participation of isoenzymes CYP2C9 and CYP3A4, while at therapeutic concentrations it does not inhibit isoenzymes CYP3A4, 1A2, 2A6, 2C9, 2D6 and 2C19.

In healthy young adult volunteers, the half-life (T _1/2) of montelukast is in the range of 2.7 to 5.5 hours, the clearance of the active substance averages 45 ml / min. After oral administration, montelukast sodium and its metabolites are excreted almost exclusively in the 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 prevention of day and night symptoms of the disease, prevention of exercise-induced 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 of age (for 4 mg Montelar tablets), 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 the use of 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 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 the pills both during the period of achieving control of the symptoms of the disease, and during the period of 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, tremors, 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 damage);
• immune system: hypersensitivity reactions, including anaphylaxis; very rarely - eosinophilic liver infiltration;
• blood coagulation system: increased tendency to bleeding;
• respiratory system: upper respiratory tract infections, nosebleeds;
• skin and subcutaneous tissues: itching, rash, tendency to hematoma formation, erythema nodosum, exudative erythema;
• allergic reactions: urticaria, angioedema;
• musculoskeletal system: myalgia (including muscle cramps), arthralgia;
• the 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 drug overdose in children when taken orally 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, hyperkinesis.

In such cases, symptomatic treatment is recommended.

There is no information on the advisability of removing montelukast using peritoneal dialysis or hemodialysis.

special instructions

Since the effectiveness of oral administration of montelukast in relieving acute attacks of bronchial asthma has not been established, it is not recommended to use Montelar in such cases. Patients should be informed about the need to always have with them means of emergency relief of acute attacks of bronchial asthma (inhaled short-acting beta ₂ -adrenomimetics).

During an exacerbation of the disease and the need to use short-acting inhaled beta ₂ -agonists to relieve asthma attacks, you should not stop taking Montelar.

It is not recommended to take acetylsalicylic acid and other non-steroidal anti-inflammatory drugs for patients with confirmed hypersensitivity to these drugs during the period of montelukast treatment, since Montelar, 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 be gradually reduced, but under conditions of medical supervision. It is not possible to abruptly replace oral or inhaled glucocorticosteroids with Montelar.

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, cardiac complications and / or neuropathy, sometimes diagnosed as Charge-Strauss syndrome, systemic eosinophilic. Although the causal relationship of these side effects with the use of leukotriene receptor antagonists has not been established, care must be taken to ensure appropriate clinical observation when reducing the dose of systemic glucocorticosteroids in patients taking montelukast.

Cases of neuropsychiatric disorders in the treatment of Montelar are described. Since these symptoms may have been caused by other causes, it is not known if they are related to 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 inform the physician if such symptoms occur.

Influence on the ability to drive vehicles and complex mechanisms

During the treatment with montelukast, drowsiness and dizziness have been reported, therefore, in the event of these signs, it is not recommended to drive vehicles and perform work requiring a quick motor / mental reaction and high concentration of attention.

Application during pregnancy and lactation

There is no reliable data on the safety of using montelukast during pregnancy and lactation. There is no information about whether the drug passes into breast milk.

According to the instructions, Montelar should be prescribed to pregnant and breastfeeding women only when the expected benefit to the mother is higher than the potential risk to the fetus / child.

Pediatric use

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

Drug interactions

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

Analogs

Montelar's analogues are: Almont, Glemont, Monax, Monkasta, Montler, Montelukast, Singlon, Singular, Ectalust and others.

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.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Montelar

Reviews of 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 insomnia as a side effect.

The price of Montelar in pharmacies

The price for Montelar per pack is approximately:

• film-coated tablets, Montelar 10 mg: 14 pcs. - 500 rubles, 28 pcs. - 850 rubles;
• chewable tablets Montelar 4 mg: 14 pcs. - 470 rubles, 28 pcs. - 760 rubles;
• chewable tablets Montelar 5 mg: 14 pcs. - 490 rubles, 28 pcs. - 850 rubles.

Montelar: prices in online pharmacies

Drug name Price Pharmacy

Montelar 5 mg chewable tablets 14 pcs. 310 RUB Buy

Montelar 4 mg chewable tablets 14 pcs. RUB 350 Buy

Montelar 10 mg film-coated tablets 14 pcs. 465 RUB Buy

Montelar tablets p.o. 10mg 14 pcs. RUB 478 Buy

Montelar 4 mg chewable tablets 28 pcs. RUB 500 Buy

Montelar 5 mg chewable tablets 28 pcs. RUB 500 Buy

Montelar tab. chewable 4mg 14 pcs. RUB 512 Buy

Montelar 10 mg film-coated tablets 28 pcs. 546 r Buy

Montelar tablets chewable. 5mg 28 pcs. 695 RUB Buy

Montelar tablets p.o. 10mg 28 pcs. 745 RUB Buy

Montelar tablets chewable. 4mg 28 pcs. 860 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!