Almont chewable tablets 4mg, No. 28

Prevention and long-term treatment of bronchial asthma, including:

• prevention of day and night symptoms of the disease in children aged 2 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg);

• treatment of bronchial asthma in children aged 6 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg) with hypersensitivity to acetylsalicylic acid;

• prevention of exercise-induced bronchospasm in children aged 2 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years old (for film-coated tablets, 10 mg).

• Relief of symptoms of seasonal and perennial allergic rhinitis in children from 2 years of age (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg).

The drug is taken orally.

Chewable tablets are taken 1 hour before or 2 hours after a meal; the tablet should be chewed.

Film-coated tablets are taken orally, regardless of food intake, without chewing, with a sufficient amount of liquid.

Adults and adolescents from 15 years of age are prescribed 10 mg (1 film-coated tablet) 1 time / day.

With bronchial asthma or bronchial asthma and allergic rhinitis, children aged 2 to 6 years are prescribed 1 chewable tablet 4 mg 1 time / day in the evening; children aged 6 to 14 years - 1 chewable tablet 5 mg 1 time / day in the evening.

For allergic rhinitis, children aged 2 to 6 years are prescribed 1 chewable tablet 4 mg 1 time / day, children aged 6 to 14 years - 1 chewable tablet 5 mg 1 time / day on an individual basis, depending on the time of the greatest exacerbation of symptoms.

No dose adjustment is required within these age groups.

The drug is taken by children under the supervision of adults.

The therapeutic effect of the drug Almont, which allows you to control the symptoms of asthma, is achieved within 24 hours after administration.

The patient is recommended to continue taking the drug, both during periods of controlled bronchial asthma, and during an exacerbation of bronchial asthma.

Patients with renal insufficiency and patients with hepatic insufficiency of mild to moderate severity do not require a special dose adjustment.

There is no data on the use of montelukast in patients with severely impaired liver function.

Elderly patients do not need dose adjustment.

No dose adjustment is required depending on the patient's gender.

Chewable tablets, oval, biconvex, pink interspersed and engraved with 'M4' on one side.

Active substance:

montelukast sodium

• Hypersensitivity to the active substance or any auxiliary component of the drug;

• children under 2 years of age (for chewable tablets 4 mg);

• children under 6 years of age (for chewable tablets 5 mg);

• children under 15 years of age (for 10 mg tablets);

• rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption;

• phenylketonuria (for chewable tablets), because the tablets contain aspartame.

pharmachologic effect

Leukotriene receptor antagonist. Cysteinyl Leukotrienes (LTC4, LTD4, LTE4) are potent pro-inflammatory eicosanoids that are released from a variety of cells, including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT), which are present in the human respiratory tract and are responsible for bronchospasm response, sputum production, vascular permeability and an increase in the number of eosinophils. Montelukast is an orally active compound with high affinity and selectivity for CysLT1 receptors. Montelukast at a dose of less than 5 mg relieves bronchospasm induced by inhalation of LTD4. The bronchodilating effect is observed within 2 hours after oral administration. The bronchodilating effect of beta2-adrenergic agonists is enhanced by taking montelukast.Montelukast suppresses both early and late stages of bronchospasm caused by exposure to antigens. Montelukast reduces the number of eosinophils in the peripheral blood in adults and children, and also significantly reduces the number of eosinophils in the airways. In patients with hypersensitivity to acetylsalicylic acid, receiving inhaled and / or oral corticosteroids, the addition of montelukast to therapy provides better disease control.the addition of montelukast to therapy provides better disease control.the addition of montelukast to therapy provides better disease control.

Indications of the drug

Prevention and long-term treatment of bronchial asthma, including:

• prevention of day and night symptoms of the disease in children aged 2 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg);

• treatment of bronchial asthma in children aged 6 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg) with hypersensitivity to acetylsalicylic acid;

• prevention of exercise-induced bronchospasm in children aged 2 years and older (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years old (for film-coated tablets, 10 mg).

• Relief of symptoms of seasonal and perennial allergic rhinitis in children from 2 years of age (for chewable tablets 4 mg and 5 mg) and in adults and adolescents from 15 years (for film-coated tablets, 10 mg).

Dosage regimen

The drug is taken orally.

Chewable tablets are taken 1 hour before or 2 hours after a meal; the tablet should be chewed.

Film-coated tablets are taken orally, regardless of food intake, without chewing, with a sufficient amount of liquid.

Adults and adolescents from 15 years of age are prescribed 10 mg (1 film-coated tablet) 1 time / day.

With bronchial asthma or bronchial asthma and allergic rhinitis, children aged 2 to 6 years are prescribed 1 chewable tablet 4 mg 1 time / day in the evening; children aged 6 to 14 years - 1 chewable tablet 5 mg 1 time / day in the evening.

For allergic rhinitis, children aged 2 to 6 years are prescribed 1 chewable tablet 4 mg 1 time / day, children aged 6 to 14 years - 1 chewable tablet 5 mg 1 time / day on an individual basis, depending on the time of the greatest exacerbation of symptoms.

No dose adjustment is required within these age groups.

The drug is taken by children under the supervision of adults.

The therapeutic effect of the drug Almont, which allows you to control the symptoms of asthma, is achieved within 24 hours after administration.

The patient is recommended to continue taking the drug, both during periods of controlled bronchial asthma, and during an exacerbation of bronchial asthma.

Patients with renal insufficiency and patients with hepatic insufficiency of mild to moderate severity do not require a special dose adjustment.

There is no data on the use of montelukast in patients with severely impaired liver function.

Elderly patients do not need dose adjustment.

No dose adjustment is required depending on the patient's gender.

Side effect

Infectious and parasitic diseases: upper respiratory tract infections.

On the part of the blood and lymphatic system: increased tendency to bleeding, thrombocytopenia.

From the immune system: hypersensitivity reactions, incl. anaphylaxis, eosinophilic liver infiltration. From the side of the psyche: pathological dreams (including nightmares), hallucinations, insomnia, somnambulism, irritability, anxiety, anxiety, agitation (including aggressive behavior or hostility), tremors, depression, disorientation, suicidal thoughts and behavior (suicidality).

From the nervous system: headache, dizziness, drowsiness, paresthesia / hypesthesia, convulsions.

On the part of the cardiovascular system: palpitations.

From the respiratory system: epistaxis.

From the gastrointestinal tract: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

From the liver and biliary tract: an increase in the activity of ALT and AST, hepatitis (including cholestatic, hepatocellular and mixed liver damage).

On the part of the skin and subcutaneous tissues: angioedema, a tendency to hematomas, urticaria, pruritus, rash, erythema nodosum, erythema multiforme.

From the musculoskeletal system: arthralgia, myalgia, including muscle cramps. Others: asthenia / fatigue, malaise, edema, pyrexia, thirst; in very rare cases, during treatment with montelukast, the development of Churg-Strauss syndrome has been reported.

Contraindications for use

• hypersensitivity to the active substance or any auxiliary component of the drug;

• children under 2 years of age (for chewable tablets 4 mg);

• children under 6 years of age (for chewable tablets 5 mg);

• children under 15 years of age (for 10 mg tablets);

• rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption;

• phenylketonuria (for chewable tablets), because the tablets contain aspartame.

Application during pregnancy and lactation

The use of the drug Almont during pregnancy is possible if the intended benefit to the mother outweighs the potential risk to the fetus. The decision to stop breastfeeding for the period of Almont use is made based on an assessment of the intended benefits for the mother and the potential risk for the child.

Overdose

Symptoms of an overdose of the drug in patients with chronic bronchial asthma when used in a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg / day for 1 week have not been identified. There are reports of acute overdose of montelukast (when taken at least 1 g / day) in the post-marketing period and in clinical studies in adults and children. Clinical and laboratory data at the same time indicate the compliance of the safety profile of the drug in children, adults and elderly patients. The most common symptoms were thirst, drowsiness, vomiting, agitation, headache, and abdominal pain.

Treatment: carrying out symptomatic therapy. There are no data on the possibility of excretion of montelukast by peritoneal dialysis or hemodialysis.

Drug interactions

In patients simultaneously receiving phenobarbital, the AUC of montelukast decreased by about 40%, however, dosage adjustment is not required in such patients. Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised, especially in children, if montelukast is used concomitantly with CYP3A4 isoenzyme inducers such as phenytoin, phenobarbital and rifampicin. Montelukast can be prescribed together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma and / or allergic rhinitis. 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 (ethinylestradiol / norethinodrel 35/1), terfenadine, digoxin and warfarin.In vitro studies have shown that montelukast is a potent inhibitor of the CYP2C8 isoenzyme. However, in the study of drug interactions in vivo between montelukast and rosiglitazone (a marker substrate, a representative of drugs primarily metabolized by the CYP2C8 isoenzyme), no confirmation of the inhibition of the CYP2C8 isoenzyme by montelukast was obtained. Thus, Combined treatment with bronchodilators Almont is a reasonable addition to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. Upon reaching the therapeutic effect of treatment with Almont, you can begin to gradually reduce the dose of bronchodilators. Combined treatment with inhaled corticosteroids Treatment with Almont provides an additional therapeutic effect for patientsusing inhaled corticosteroids. Upon reaching the stabilization of the state, you can begin a gradual decrease in the dose of corticosteroids under the supervision of a physician. In some cases, complete abolition of inhaled corticosteroids is permissible, however, abrupt replacement of inhaled corticosteroids with Almont is not recommended.