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active ingredient: Montelukast;

1 film-coated tablet contains Montelukast Sodium equivalent to Montelukast 10 mg;

excipients: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate, Opadri yellow (hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), iron oxide yellow (E 172), carnauba wax, Iron Oxide Red (E 172)).

Dosage form. Film-coated tablets.

Basic physical and chemical properties: round biconvex tablets of beige color, film-coated, with the inscription "G" on one side and "392" on the other side.

Pharmacotherapeutic group.

Means for systemic use in obstructive airway diseases. Leukotriene receptor blockers.

ATX code R03D C03.

Clinical characteristics.


Additional treatment of bronchial asthma in patients with persistent mild to moderate asthma, insufficiently controlled by inhaled corticosteroid drugs, as well as with insufficient clinical control of asthma with short-acting beta-agonists, used if necessary. Symptomatic treatment of seasonal allergic rhinitis in patients with bronchial asthma.

Prevention of asthma, the dominant component of which is exercise-induced bronchospasm.

Relief of symptoms of seasonal and year-round allergic rhinitis.


Hypersensitivity to any of the components of the drug. Children under 15 years of age (for a dose of 10 mg).

Interactions with other drugs and other types of interactions.

Montelukast can be prescribed together with other medications for the prevention or long-term treatment of asthma and allergic rhinitis. When studying drug interactions, the recommended dose of Montelukast did not have a significant clinical effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

In patients taking phenobarbital at the same time, the area under the concentration-time curve (AUC) for Montelukast decreased by about 40 %. Since montelukast is metabolized by sur 3A4, caution should be exercised, especially in children, if montelukast is administered concomitantly with SUR 3A4 inducers, such as phenytoin, phenobarbital, and rifampicin.

In vitro studies have shown that montelukast is a potent inhibitor of CYP 2c8. However, data from a clinical drug interaction study involving Montelukast and rosiglitazone (a drug metabolized by CYP 2c8) showed that montelukast is not an inhibitor of CYP 2c8 in vivo. Thus, Montelukast does not significantly affect the metabolism of drugs metabolized by this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).

In vitro studies have shown that montelukast is a substrate of CYP 2c8 and, to a lesser extent, 2C9 and 3A4. In a clinical study of drug interactions with Montelukast and gemfibrozil (an inhibitor of CYP2C8 and 2c9), gemfibrozil increased systemic exposure to Montelukast by 4.4 times. When used concomitantly with gemfibrozil or other potent CYP 2c8 inhibitors, no dose adjustment of Montelukast is required, but the doctor should consider the increased risk of adverse reactions.

According to the results of in vitro studies, clinically important interactions with less potent CYP2C8 inhibitors (for example, trimethoprim) are not expected. Concomitant use of Montelukast with itraconazole, a strong CYP 3A4 inhibitor, did not significantly increase systemic exposure to Montelukast.

Application features.

Patients should be warned that Glemont should not be used to relieve acute asthmatic attacks. It is recommended to continue treatment with the usual appropriate medications to relieve seizures. In case of an acute attack, short-acting inhaled beta-agonists should be used. Patients should consult their doctor as soon as possible if they need more than usual inhalations of short-acting beta-agonists.

Montelukast therapy should not be abruptly replaced with inhaled or oral corticosteroid medications.

There is no evidence to support that the dose of oral corticosteroids can be reduced with concomitant use of Montelukast.

Neuropsychiatric events have been reported in patients taking Montelukast (see Section "adverse reactions"). Since these phenomena may be influenced by other factors, it is not known whether these phenomena are related to the use of Montelukast. Doctors should discuss these adverse events with their patients and/or their caregivers. Patients and / or caregivers should be instructed to inform their doctor when such changes occur.

In isolated cases, patients receiving anti-asthmatic agents, including Montelukast, may experience systemic eosinophilia, sometimes together with clinical manifestations of vasculitis, the so-called Charg-Ostrich syndrome (granulomatous allergic angiitis), which is treated with systemic corticosteroid therapy. Such cases were usually (but not always) associated with a reduction or discontinuation of corticosteroid therapy. The possibility that leukotriene receptor antagonists may be associated with the appearance of Charg – Ostrich syndrome cannot be refuted or confirmed, so doctors should be warned about the possibility of eosinophilia, vasculitis rash, worsening of pulmonary symptoms, complications from the cardiac system and/or neuropathy in patients. Patients who have developed the above symptoms should be re-examined, and their treatment regimen should be reviewed again.

Treatment with Montelukast does not allow patients with aspirin-dependent asthma to use aspirin or other nonsteroidal anti-inflammatory drugs.

Patients with rare hereditary diseases such as galactose intolerance, Lappa lactase deficiency, or glucose-galactose malabsorption should not use this medication.

The drug contains less than 1 mmol (23 mg) of sodium per tablet, that is, it is practically free of sodium.

Use during pregnancy or lactation.

Pregnancy. Animal studies have not shown any harmful effects on effects on pregnancy or embryonic/fetal development.

Limited information in the pregnancy database does not indicate a causal relationship between the use of Montelukast and the occurrence of malformations (such as limb defects), which were rarely reported in the world post-marketing experience of use.

Montelukast can only be used during pregnancy if it is considered absolutely necessary.

Breast-feeding. Studies in rats have shown that Montelukast penetrates milk. It is not known whether Montelukast penetrates into breast milk in women.

Montelukast can be used during breast-feeding only if it is considered absolutely necessary.

Ability to influence the reaction rate when driving vehicles or other mechanisms.

Montelukast is not expected to affect the patient's ability to drive vehicles or other mechanisms. However, drowsiness or dizziness was very rarely reported.

Dosage and administration.

The drug is intended for use in adults and children over 15 years of age.

For the treatment of asthma or asthma in combination with seasonal allergic rhinitis for adults and children over 15 years of age, the recommended dose is 1 tablet of 10 mg 1 time a day, in the evening. To relieve the symptoms of allergic rhinitis, the time of admission should be selected individually.

Dose adjustment is not required for elderly patients, as well as patients with mild to moderate hepatic insufficiency or renal insufficiency. There are no data on dose adjustment for patients with severe hepatic insufficiency. There are no data on the pharmacokinetics of Montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child – Pugh scale), so there are no recommendations for dose adjustment.

The dosage of the drug is the same for male and female patients.

Treatment with Glemont depends on other asthma treatments.

The drug can be added to the patient's existing course of treatment.

Inhaled corticosteroids. Glemont can be used as an adjunct treatment in patients in whom inhaled corticosteroids together with short-acting beta-agonists, used if necessary, do not provide satisfactory clinical control of the disease.

Glemont should not be abruptly replaced with inhaled corticosteroids (see the section "application features").


Apply to children over 15 years of age. Children under 15 years of age should use the drug in the form of chewable tablets with the appropriate dosage.


There is no specific information regarding the treatment of Montelukast overdoses. In studies of chronic asthma, Montelukast was prescribed at doses up to 200 mg/day to adult patients for 22 weeks, and in short – term studies-up to 900 mg/day for approximately one week, with no clinically significant adverse reactions.

Acute overdose of Montelukast has been reported with post-marketing use and during clinical trials. These included taking the drug in adults and children in doses exceeding 1000 mg (approximately 61 mg/kg, a child aged 42 months). The obtained clinical and laboratory data corresponded to the safety profile for adult patients and children.

In most cases of overdose, no adverse reactions were reported. The most common adverse reactions were those that corresponded to the safety profile of Glemont and included: abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity.

It is not known whether montelukast is eliminated by peritoneal dialysis or hemodialysis. Treatment is symptomatic.

Tags: Montelukast