Almont, 4 mg 28 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.

Active ingredient

Montelukast

Composition

1 tablet chewable 4 mg contains:

active ingredient:

Montelukast 4.00 mg (as Montelukast sodium 4.16 mg);

excipients:

mannitol 160.96 mg,

microcrystalline cellulose 52.80 mg,

How to take, the dosage

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

The drug ALMONT should be taken 1 hour before or 2 hours after meals.

In bronchial asthma or bronchial asthma and allergic rhinitis:

For children at the age from 2 to 6 years old – 1 chewable tablet in the dose of 4 mg once a day in the evening.

For children aged 6 to 14 years – 1 chewable tablet at a dose of 5 mg once a day in the evening.

In allergic rhinitis:
For children aged 2 to 6 years – 1 chewable tablet in a dose of 4 mg once a day and for children aged 6 to 14 years – 1 chewable tablet in a dose of 5 mg once a day on an individual basis depending on the time of the greatest exacerbation of symptoms.

It is not required to correct the dose within these age groups.

General recommendations

Therapeutic effect of the drug ALMONT, allowing to control asthma symptoms, is achieved within 24 hours after intake. The patient is recommended to continue taking the drug both in periods of controlled course of bronchial asthma and in the period of exacerbation of bronchial asthma.

Patients with renal insufficiency and patients with hepatic insufficiency of mild to moderate severity do not require special dose adjustment. No dosage adjustment depending on the gender of the patient is required.

There are no data on the use of Montelukast in patients with severe liver function disorders.

A different dosage form and dose of the drug – film-coated tablets, 10 mg is available for treatment of patients in other age groups.

Interaction

In patients who received phenobarbital concomitantly, the area under the pharmacokinetic curve “concentration-time” of montelukast decreased by about 40%, but dosage regimen adjustment is not required in these patients. Since montelukast is metabolized by CYP3A4 isoenzyme, caution should be exercised, especially in children, if montelukast is simultaneously used with CYP3A4 isoenzyme inducers, such as phenytoin, phenobarbital and rifampicin.

Montelukast can be prescribed together with other drugs traditionally used for prevention and long-term treatment of bronchial asthma and/or allergic rhinitis.

Montelukast at the recommended therapeutic dose had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/noretinodrel 35/1), terfenadine, digoxin and warfarin.

In in vitro studies it was found that montelukast is a strong inhibitor of CYP2C8 isoenzyme. However, in the study of drug interaction in vivo of montelukast and rosiglitazone (marker substrate, a representative of drugs primarily metabolized by CYP2C8 isoenzyme) there was no confirmation of inhibition of CYP2C8 isoenzyme by montelukast. Thus, in clinical practice, the effect of montelukast on CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide is not expected.

In vitro studies have shown that montelukast is a substrate of CYP2C8 isoenzyme, and to a lesser extent, CYP2C9 and 3A4 isoenzymes. The data of clinical study of drug interaction in relation to Montelukast and gemfibrozil (inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the effect of systemic effect of Montelukast by 4.4 times. Co-administration of itraconazole, a strong CYP3A4 isoenzyme inhibitor, together with gemfibrozil and montelukast did not lead to an additional increase in the effect of systemic effects of montelukast.

The effect of gemfibrozil on the systemic effects of montelukast cannot be considered clinically significant based on safety data when used at doses greater than the approved dose of 10 mg for adult patients (e.g., 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, no dose adjustment of montelukast is required when coadministered with gemfibrozil. According to the results of in vitro studies, no clinically significant drug interactions with other known CYP2C8 isoenzyme inhibitors (e.g., trimethoprim) are expected. In addition, co-administration of montelukast with itraconazole alone did not result in a significant increase in the systemic effect of 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. Upon achieving therapeutic effect of ALMONT treatment it is possible to start gradual reduction of the dose of bronchodilators.

Combined treatment with inhaled GCS

The treatment with ALMONT provides additional therapeutic effect for patients using inhaled GCS. Once the condition is stabilized, a gradual reduction in the dose of GCS under medical supervision may be started. In some cases, complete abolition of inhaled GCS is acceptable, but abrupt replacement of inhaled GCS by ALMONT is not recommended.

Special Instructions

Almont is not recommended for the treatment of acute attacks of bronchial asthma. Patients with bronchial asthma are recommended to have emergency medications with them at all times. When an acute attack occurs, short-acting inhaled beta-adrenomimetics should be used. Patients should consult their physician as soon as possible if they need more short-acting inhaled beta-adrenomimetics than usual.

Almont should not be abruptly replaced with inhaled or oral GCS therapy. There is no evidence to support the possibility of reducing the dose of oral GCS with concomitant administration of montelukast.

In rare cases, patients who receive anti-asthmatic drugs, including montelukast, may develop systemic eosinophilia, sometimes accompanied by clinical signs of vasculitis, the so-called Churg-Strauss syndrome, a condition that is treated by taking systemic GCS. These cases are usually associated with dose reduction or withdrawal of oral GCS therapy. The possibility that leukotriene receptor antagonists may be associated with the development of Charge-Stross syndrome cannot be excluded or established.

Physicians should therefore be alerted to the possibility of eosinophilia, vascular rash, increased severity of pulmonary symptoms, cardiac complications, and/or neuropathy in patients. Patients who have developed the above symptoms should be reevaluated and their treatment regimen reconsidered. Treatment with Almont does not prevent 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 be harmful to patients with phenylketonuria.

The product contains lactose monohydrate, and should not be used in patients with rare inherited conditions: galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Impact on driving and operating machinery

In general, montelukast does not affect the ability to drive vehicles or operate other mechanisms, but very rarely some patients have reported drowsiness and dizziness; if these symptoms occur, patients should not drive vehicles or engage in other activities that require concentration and rapid psychomotor reactions.

Contraindications

• Hypersensitivity to the active ingredient or any excipient of the product
• children under 2 years of age (for 4 mg doses) and under 6 years of age (for 5 mg doses);
• Patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• phenylketonuria (contains aspartame).

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Side effects

Infectious and parasitic diseases: upper respiratory tract infections.

Blood and lymphatic system disorders: increased susceptibility to bleeding, thrombocytopenia.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, eosinophilic liver infiltration.Irritability, anxiety, restlessness; agitation, including aggressive behavior or hostility; tremor, depression, disorientation, suicidal thoughts and behavior (suicidality).

Nervous system disorders: headache, dizziness, somnolence, paresthesia/hypoesthesia, seizures.

Heart disorders: palpitations.

Respiratory system, chest and mediastinum disorders: nasal bleeding.

Gastrointestinal disorders: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

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

Skin and subcutaneous tissue disorders: angioedema, tendency to haematoma, urticaria, pruritus, rash, 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 Churg-Strauss syndrome has been reported during treatment with montelukast (see section “Special Precautions”).

Overdose

Symptoms of drug overdose in patients with chronic bronchial asthma when administered at a dose greater than 200 mg daily for 22 weeks and at a dose of 900 mg daily for 1 week have not been identified.

There have been reports of acute overdose of montelukast (when administered at least 1 g per day) in the post-marketing period and in clinical trials in adults and children.

The clinical and laboratory data in this case suggest that the safety profile of the drug in children, adults and elderly patients is consistent. The most frequent symptoms were feeling of thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain. Treatment: administration of symptomatic therapy.

Similarities

Singular, Montelar, Montelukast, Singlon, Montelukast, Almont, Glémont