Almont pills 10mg №28

Clinico-pharmacological group: Antagonist of leukotriene receptors. A drug for the treatment of bronchial asthma and allergic rhinitis.
Pharmaco-therapeutic group: Leukotriene receptor antagonist

Indications

Prevention and long-term treatment of bronchial asthma in children, including:
- prevention of day and night symptoms of the disease (for children aged 2 years and older);
- treatment of bronchial asthma in patients with hypersensitivity to Acetylsalicylic acid (for children 6 years and older);
- prevention of bronchospasm caused by exercise (for children aged 2 years and older).

Relieving the symptoms of seasonal and year-round allergic rhinitis in children from 2 years.

Dosing regimen

Is ingested 1 hour before or 2 hours after eating. The pill should be chewed.

Children take the drug under the supervision of adults.

Bronchial asthma or bronchial asthma and allergic rhinitis

For children aged 2 to 6 years - 1 chewable pill 4 mg 1 time / day in the evening.

For children aged 6 to 14 years - 1 chewable pill 5 mg 1 time / day in the evening.

Allergic rhinitis

For children aged 2 to 6 years - 1 chewable pill 4 mg 1 time / day and for children aged 6 to 14 years - 1 chewable pill at a dose of 5 mg 1 time / day in an individual mode depending on the time of greatest exacerbation symptoms.

No dose adjustment is required within these age groups.

The therapeutic effect of the drug Montetelast, which allows to control the symptoms of asthma, is achieved within a day after taking it. The patient is recommended to continue taking the drug, both during periods of controlled flow of asthma, and in the period of exacerbation of bronchial asthma.

Patients with renal insufficiency and patients with mild to moderate hepatic insufficiency do not require special dose selection. There is no data on the use of montelukast in patients with severely impaired liver function.

No dose adjustment required depending on the gender of the patient.

For the treatment of patients of other age groups, a different dosage form and dose of the drug are available - film-coated tablets, 10 mg.

Side effect

Infectious and parasitic diseases: upper respiratory tract infections.

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

On the part of the immune system: hypersensitivity reactions, including anaphylaxis, eosinophilic infiltration of the liver.

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

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

Since the cardiovascular system: palpitations.

On the part of the respiratory system: nosebleeds.

On the part of the digestive system: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

On the part of 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, tendency to hematomas, urticaria, pruritus, rash, erythema nodosum, erythema multiforme.

On the part of the musculoskeletal and connective tissues: arthralgia, myalgia, including muscle cramps.

General disorders: asthenia / fatigue, malaise, edema, pyrexia, thirst.

Other: in very rare cases, during the treatment with montelukast, the development of Chardzh-Stross syndrome has been reported.

Contraindications

- hypersensitivity to the active or any excipient of the drug;

- patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- Phenylketonuria (contains aspartame);

- children's age up to 2 years (for a dosage of 4 mg);

- children's age up to 6 years (for a dosage of 5 mg).

Use during pregnancy and lactation

Use of the drug Montelasta during pregnancy is possible if the intended benefit to the mother outweighs the potential risk to the fetus.

The decision to cancel breastfeeding for the period of use of the drug Montelasta is made on the basis of an assessment of the intended benefits to the mother and the potential risk to the child.

special instructions

Montelast is not recommended to be prescribed for the treatment of acute attacks of bronchial asthma. Patients with bronchial asthma are advised to always carry emergency medications with them. In the event of an acute attack, inhaled short-acting beta2-adrenomimetics should be used. Patients should consult their physician as soon as possible if they need more inhalations of short-acting beta2-adrenergic mimetics than usual.

Do not abruptly replace the drug Montelasti therapy with inhaled or oral GCS. There are no data proving the possibility of reducing the dose of oral corticosteroids against the background of simultaneous montelukast.

In rare cases, patients who receive anti-asthma drugs, including montelukast, can develop systemic eosinophilia, which is sometimes accompanied by clinical signs of vasculitis, the so-called Chardzh-Stross syndrome, a condition that is eliminated by taking systemic corticosteroids. These cases are usually associated with dose reduction or cancellation of therapy with oral corticosteroids. It is impossible to exclude or establish the likelihood that leukotriene receptor antagonists may be associated with the development of Chard Stross syndrome.Therefore, physicians should be warned about the possibility of eosinophilia, vascular rash, increased severity of pulmonary symptoms, cardiac complications and / or neuropathy in patients. Patients who have developed the aforementioned symptoms need to undergo a re-examination, and their treatment regimen should be reviewed. Treatment with Montelast does not prevent the development of bronchospasm in patients with hypersensitivity to acetylsalicylic acid, when using acetylsalicylic acid and other NSAIDs.

The drug Montelasta contains aspartame, a source of phenylalanine. This drug may be harmful to patients with phenylketonuria.

The drug contains lactose monohydrate and should not be taken in patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Influence on ability to drive motor transport and control mechanisms
As a rule, montelukast does not affect the ability to drive vehicles or work with other mechanisms, but very rarely drowsiness and dizziness were noted in some patients, when these symptoms appear, patients are not recommended to drive vehicles and engage in other activities requiring concentration and speed psychomotor reactions.

Overdose

Symptoms of drug overdose in patients with chronic bronchial asthma when used at 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 taking at least 1 g / day) in the post-marketing period and in clinical studies in adults and children. Clinical and laboratory data testify to the compliance of the safety profile of the drug in children, adults and elderly patients. The most frequent symptoms were thirst, drowsiness, vomiting, agitation, headache and abdominal pain.
Treatment: symptomatic treatment. Data on the possibility of removal of montelukast by peritoneal dialysis or hemodialysis are not available.

Drug interaction

In patients treated with phenobarbital at the same time, the AUC of Montelukast decreased by approximately 40%; however, no adjustment of the dosage regimen is required in these patients.

Since montelukast is metabolized by the 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 the prevention and long-term treatment of asthma and / or allergic rhinitis.

Montelukast in the recommended therapeutic dose had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / noretinodrel 35/1), terfenadine, Digoxin and Warfarin.

In vitro studies have shown that montelukast is a potent inhibitor of the isoenzyme CYP2C8. However, in the study of drug interaction in vivo of montelukast and rosiglitazone (a marker substrate, a representative of drugs that are primarily metabolized by the isoenzyme CYP2C8), no confirmation of the inhibition by montelukast of the isoenzyme CYP2C8 was obtained. Thus, in clinical practice, Montelukast is not supposed to influence CYP2C8-mediated metabolism of a number of drugs, including Paclitaxel, rosiglitazone, repaglinide.

In vitro studies have shown that montelukast is a substrate of an isoenzyme CYP2C8, and to a lesser extent isoenzymes CYP2C9 and CYP3A4. Data from a clinical study of drug interactions for montelukast and gemfibrozil (an inhibitor of both CYP2C8 and CYP2C9) demonstrate that gemfibrozil increases the effect of the systemic effect of montelukast 4.4 times. The combined use of itraconazole, a strong inhibitor of the CYP3A4 isoenzyme, together with gemfibrozil and montelukast did not lead to an additional increase in the effect of the systemic effect of montelukast. The effect of gemfibrozil on the systemic effect of montelukast cannot be considered clinically significant based on safety data when used in doses exceeding the approved dose of 10 mg for adult patients (for example,200 mg / day for adult patients for 22 weeks and up to 900 mg / day for patients taking the drug for about 1 week, no clinically significant adverse effects were observed). Thus, when combined with gemfibrozil, the dose adjustment of Montelukast is not required. According to the results of in vitro studies, no clinically significant drug interactions with other known inhibitors of the CYP2C8 isoenzyme (for example, with trimethoprim) are expected. In addition, co-administration of montelukast with itraconazole alone did not lead to a significant increase in the effect of the systemic effect of montelukast.

Combined treatment with bronchodilators

The drug Montelast is a reasonable supplement to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. Upon reaching the therapeutic effect of Montetelast treatment, you can begin a gradual reduction in the dose of bronchodilators.

Combined treatment with inhaled corticosteroids

Monteselast treatment provides an additional therapeutic effect to patients using inhaled GCS. Upon reaching stabilization, you can begin a gradual reduction in the dose of corticosteroids under medical supervision. In some cases, the complete abolition of inhaled GCS is permissible, however, abrupt replacement of inhaled GCS with Montelasti is not recommended.