Almont, 10 mg 98 pcs.

Bronchospasm, Bronchial asthma, Runny nose (rhinitis)

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

• preventing daytime and nighttime symptoms of the disease (for children 2 years and older);
• Treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid (for children 6 years and older);
• preventing exercise-induced bronchospasm (for children 2 years and older).

Promotion of symptoms of seasonal and year-round allergic rhinitis in children from 2 years of age.

Indications

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

prevention of daytime and nighttime symptoms of the disease (for children aged 2 years and older);
treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid (for children aged 6 years and older);
prevention of bronchospasm caused by physical activity (for children aged 2 years and older).

Relief of symptoms of seasonal and year-round allergic rhinitis in children from 2 years of age.

Pharmacological effect

Pharmacotherapeutic group:

Special instructions

The drug Almont is not recommended for the treatment of acute attacks of bronchial asthma. Patients with bronchial asthma are advised to always carry emergency medications with them. When an acute attack occurs, short-acting inhaled betag-adrenergic agonists should be used. Patients should consult their physician as soon as possible if they require more inhaled short-acting betag-agonists than usual.

You should not abruptly replace Almont with inhaled or oral corticosteroids. There are no data proving the possibility of reducing the dose of oral corticosteroids while taking montelukast.

In rare cases, patients receiving antiasthmatic drugs, including montelukast, may develop systemic eosinophilia, sometimes accompanied by clinical signs of vasculitis, the so-called Charge-Strauss syndrome, a condition that is treated with systemic corticosteroids.

These cases are usually associated with dose reduction or discontinuation of oral corticosteroid therapy. The possibility that leukotriene receptor antagonists may be associated with the development of Charge-Strauss syndrome cannot be excluded or established.

Therefore, physicians should be alerted to the possibility of eosinophilia, vascular rash, increased severity of pulmonary symptoms, cardiac complications, and/or neuropathy in patients. Patients who develop the above symptoms should be re-evaluated and their treatment regimen reviewed.

Treatment with Almont does not prevent the development of bronchospasm in patients with hypersensitivity to acetylsalicylic acid when using acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Almont contains aspartame, a source of phenylalanine. This drug may cause harm to the health of patients with phenylketonuria.

The drug contains lactose monohydrate and should not be taken by patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Impact on the ability to drive vehicles and machinery
As a rule, montelukast does not affect the ability to drive vehicles or operate other mechanisms, but very rarely, some patients have experienced drowsiness and dizziness; when these signs appear, patients are not recommended to drive vehicles or engage in other activities that require concentration and speed of psychomotor reactions.

Active ingredient

Montelukast

Composition

1 film-coated tablet contains:

active substance:

montelukast 10.00 mg (as montelukast sodium 10.40 mg);

excipients:

core – microcrystalline cellulose, type 102 89.30 mg, hyprolose 4.00 mg, croscarmellose sodium 6.00 mg, lactose monohydrate 89.30 mg, magnesium stearate 1.00 mg;

film shell – Opadry II Beige 31F27012 (lactose monohydrate 1.440 mg, hypromellose 15cP 1.120 mg, titanium dioxide 1.011 mg, macrogol 4000 0.400 mg, iron dye yellow oxide 0.026 mg, iron dye red oxide 0.003 mg) 4.0 mg.

Contraindications

Hypersensitivity to the active or any excipient of the drug;
children up to 2 years of age (for a dosage of 4 mg) and up to 6 years of age (for a dosage of 5 mg);
patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
phenylketonuria (contains aspartame).

Side Effects

Infectious and parasitic diseases: upper respiratory tract infections.
Disorders of the blood and lymphatic system: increased tendency to bleeding, thrombocytopenia.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, eosinophilic infiltration of the liver.

Mental disorders: pathological dreams, including nightmares; hallucinations, insomnia, somnambulism, irritability, anxiety, restlessness; agitation, including aggressive behavior or hostility; tremor, depression, disorientation, suicidal thoughts and behavior (suicidality).

Nervous system disorders: headache, dizziness, drowsiness, paresthesia/hypoesthesia, convulsions.

Cardiac disorders: palpitations.

Disorders of the respiratory system, chest and mediastinal organs: nosebleeds.
Gastrointestinal disorders: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

Disorders of the liver and biliary tract: increased activity of alanine aminotransferase and aspartate aminotransferase, hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

Skin and subcutaneous tissue disorders: angioedema, tendency to hematoma, urticaria, pruritus, rash, erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue disorders: arthralgia, myalgia, including muscle cramps.

General disorders and disorders at the injection site: asthenia/fatigue, malaise, edema, pyrexia, thirst.
In very rare cases, the development of Charge-Strauss syndrome has been reported during treatment with montelukast (see section “Special Instructions”).

Interaction

In patients simultaneously receiving phenobarbital, the area under the pharmacokinetic concentration-time curve of montelukast decreased by approximately 40%, but no dosage adjustment is required in such patients. Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised, especially in children, if montelukast is co-administered with CYP3A4 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 (ethinyl estradiol/norethinodrel 35/1), terfenadine, digoxin and warfarin.

In vitro studies have shown that montelukast is a strong inhibitor of the CYP2C8 isoenzyme. However, when studying the in vivo drug interaction between montelukast and rosiglitazone (a marker substrate, a representative of drugs primarily metabolized by the CYP2C8 isoenzyme), no confirmation of inhibition of the CYP2C8 isoenzyme by montelukast was obtained. Thus, in clinical practice, the effect of montelukast on the CYP2C8-mediated metabolism of a number of drugs, incl. paclitaxel, rosiglitazone, repaglinide.

In vitro studies have shown that montelukast is a substrate of the CYP2C8 isoenzyme, and to a lesser extent the CYP2C9 and 3A4 isoenzymes. Data from a clinical drug interaction study of montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times.

Co-administration of itraconazole, a strong inhibitor of the CYP3A4 isoenzyme, with gemfibrozil and montelukast did not lead to an additional increase in the effect of systemic exposure to montelukast.

The effect of gemfibrozil on systemic exposure to montelukast may not be considered clinically significant based on safety data at doses greater than the approved dose of 10 mg for adult patients (eg, 200 mg/day for adult patients for 22 weeks and up to 900 mg/day for patients taking the drug for approximately one week, no clinically significant adverse effects were observed).

Thus, when co-administered with gemfibrozil, no dose adjustment of montelukast is required. Based on the results of in vitro studies, clinically significant drug interactions with other known inhibitors of the CYP2C8 isoenzyme (for example, trimethoprim) are not expected. In addition, co-administration of montelukast with itraconazole alone did not significantly increase the effect of systemic exposure to montelukast.

Combined treatment with bronchodilators

The drug ALMONT is a reasonable addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. Once the therapeutic effect of treatment with ALMONT is achieved, a gradual reduction in the dose of bronchodilators can begin.

Combined treatment with inhaled corticosteroids

Treatment with ALMONT provides an additional therapeutic effect for patients using inhaled corticosteroids. Once the condition has stabilized, you can begin to gradually reduce the dose of GCS under the supervision of a physician. In some cases, complete abolition of inhaled corticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with the drug ALMONT is not recommended.

Overdose

Symptoms of drug overdose in patients with chronic bronchial asthma when used at a dose exceeding 200 mg per day for 22 weeks and at a dose of 900 mg per day for 1 week have not been identified.

There are reports of acute overdose of montelukast (when taking at least 1 g per day) in the post-marketing period and in clinical studies in adults and children.

Clinical and laboratory data indicate that the safety profile of the drug is consistent in children, adults and elderly patients. The most common symptoms were thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain.

Treatment: symptomatic therapy.

Shelf life

3 years.