Montelukast chewable pills 5 mg №28

Indications

- prevention and long-term treatment of asthma, including the prevention of day and night symptoms of the disease;

- treatment of bronchial asthma in patients with hypersensitivity to Acetylsalicylic acid;

- prevention of bronchospasm caused by exercise;

- relief of day and night symptoms of seasonal allergic rhinitis and persistent allergic rhinitis.

Dosing regimen

Montelukast drug is taken orally 1 time / day, regardless of the reception of the poor. The pill can be swallowed whole or chewed before swallowing. For the treatment of bronchial asthma the drug should be taken in the evening. In the treatment of allergic rhinitis The drug can be taken at any time of the day. Patients with asthma and allergic rhinitis should take 1 pill 1 time / day in the evening.

Children aged 6 to 14 years

1 chewable pill 5 mg 1 time / day. Dose selection for this age group is not required.

Children over 15 and adults

The dose for adults and children over 15 years old is 10 mg montelukast per day. The therapeutic effect of the drug Montelukast on the indicator, reflecting the course of bronchial asthma, develops during the first day. The patient should continue to take the drug in the period to achieve control of symptoms of bronchial asthma, and in the period of exacerbation of the disease.

For elderly patients, patients with renal insufficiency, patients with mild or moderately impaired liver function, no special dose selection is required.

Montelukast can be added to the treatment of bronchodilator and inhaled GCS.

Adverse Effects

Side effects are usually mild and, as a rule, do not require discontinuation of the drug.

Nervous system: headache, dizziness, drowsiness, paresthesia / ginesthesia, convulsions.

Cardiovascular: cardiopalmus.

On the part of the respiratory system, organs of the chest and mediastinum: nasal bleeding, pulmonary eosinophilia.

Psychological: agitation, incl. aggressive behavior or hostility, anxiety, depression, disorientation, impaired attention, pathological dreams, hallucinations. insomnia. memory impairment, psychomotor activity (including irritability, anxiety and tremor), somnambulism, suicidal thoughts and behavior (suicidality).

From the side. diarrhea, dyspepsia, nausea, vomiting, pancreatitis, abdominal pain.

Disorders of the liver and biliary tract: increased activity of ALT and ACT, hepatitis (including cholestatic, hepatocellular and mixed liver damage).

From the organs of the musculoskeletal system: arthralgia, myalgia. muscle cramps.

From the blood and lymphatic system: increased tendency to bleeding, thrombocytopenia.

Dermatological: propensity to form hematomas, erythema nodosum, erythema multiformpa, pruritus. rash, urticaria, angioedema.

Immune system: hypersensitivity reactions, incl. anaphylaxis, eosiophilus infiltration of the liver.

Infection: upper respiratory tract infection.

Other: asthenia (weakness) / weariness. swelling, pyrexia.

Contraindications

- Hypersensitivity to any of the components of the drug;

- children's age up to 6 years;

- Phenylketonuria.

Pregnanacy and breastfeeding

There were no clinical trials of montelukast involving pregnant women. Montelukast should be used during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or baby. During post-registration use of Montelukast, the development of congenital limb defects in newborns whose mothers took Montelukast during pregnancy was reported. Most of these women also took other drugs for the treatment of bronchial asthma during pregnancy. The causal relationship between taking Montelukast and the development of congenital defects of the limbs has not been established.

It is not known whether montelukast is excreted in breast milk. Since many drugs are excreted in breast milk, it is necessary to take this into account when prescribing Montelukast for breastfeeding women.

Application for violations of the liver

Changes in the dose of montelukast are not required for patients with mild to moderate hepatic insufficiency.

Application for violations of kidney function

Since montelukast and its metabolites are not excreted via the kidneys, the pharmacokinetics of montelukast in patients with renal insufficiency have not been evaluated. Adjustment of the drug dose for this group of patients is not required.

Use in children

Do not use children under 6 years old.

For children aged 6 to 14, take 1 chewable pill 5 mg 1 time / day.

Special notes

The effectiveness of montelukast for oral administration in relation to the treatment of acute attacks of bronchial asthma has not been established. Therefore, the drug Montelukast pills is not recommended to be prescribed for the treatment of acute attacks of asthma. Patients should be instructed to always carry emergency medications with them to relieve asthma attacks (inhaled β₂short-acting agonists).

Do not stop taking the drug Montelukast in the period of exacerbation of asthma. It should be remembered about the need to use emergency medications to relieve seizures (inhaled β₂agonists short action).

Patients with confirmed allergy to acetylsalicylic acid and other NSAIDs should not take these drugs during treatment with Montelukast, since montelukast, improving respiratory function in patients with allergic bronchial asthma, however, cannot completely prevent the bronchoconstriction caused by NSAIDs.

Dose of GCS for inhalation or oral administration taken during treatment with montelukast. can be gradually reduced under the supervision of a physician. However, a sharp replacement of GCS with Montelukast cannot be performed. Neuropsychiatric disorders were described in patients taking Montelukast (see the “Side Effects” section). Considering that these symptoms could have been caused by other factors, it is not known whether they are associated with montelukast. The physician should discuss this undesirable phenomenon with patients and / or their parents / guardians. It is necessary to explain to patients and / or their parents / guardians that if such symptoms occur, you must inform the attending physician.

In rare cases, patients receiving anti-asthma drugs, including leukotriene receptor antagonists, experienced one or more of the following adverse events: eosinophilia. rash, worsening pulmonary symptoms, cardiac complications and / or neuropathy. sometimes diagnosed as Chardzha-Strauss syndrome. systemic eosinophilic vasculitis. These cases have sometimes been associated with dose reduction or withdrawal of corticosteroid therapy for oral administration. Although the causal relationship between these adverse events and the therapy of leukotriene receptor antagonists has not been established, caution must be exercised in patients taking Montelukast and appropriate clinical observation should be carried out.

The drug Montelukast chewable pills 5 mg contains aspartame - a source of phenylalanip. Patients with phenylketonuria should be informed that each chewable pill contains aspartame in an amount equivalent to 0.842 mg of phenylalanip, and Montelukast 5 mg chewable pills should not be taken in patients with phenylketonuria.

Impact on the ability to drive vehicles and mechanisms

Evidence of this. that the use of montelukast affects the ability to drive a car or moving machinery has not been identified. However, when using the drug, side effects such as dizziness and drowsiness may occur. In view of this, care should be taken when driving vehicles and performing actions that require the speed of psychomotor reactions.

Overdosage

Symptoms

Data on symptoms of overdose when taking montelukast patients with bronchial asthma at a dose of more than 200 mg / day for 22 weeks and at a dose of 900 mg / day for one week, was not detected.

There have been cases of acute overdose (reception of at least 1000 mg / day) with montelukast during the post-registration period and during clinical trials in adults and children. Clinical and laboratory data indicated the comparability of the safety profiles of Montelukast in children, adults and elderly patients.

The most frequent side effects were thirst, drowsiness, vomiting, agitation, headache, abdominal pain, mydriasis. These side effects are consistent with the security profile of Montelukast.

Treatment

Treatment for acute overdose is symptomatic. No information is available on the specific treatment of montelukast overdose. There is no evidence of the effectiveness of peritoneal dialysis or hemodialysis.

Drug interaction

Montelukast can be prescribed together with other drugs, which are usually used for the prevention and long-term treatment of bronchial asthma and / or treatment of allergic rhinitis. The recommended therapeutic dose of Montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone. oral contraceptives (ethinyl estradiol / norethisterone 35/1). terfenadine, dngoxine and Warfarin . The AUC value of Montelukast decreases with simultaneous administration of phenobarbital by about 40%. but this does not require changing the dosage regimen of the drug Montelukast.

In vitro studies have shown that montelukast inhibits the CYP2C8 isoenzyme of the cytochrome P450 system. however, in the study of drug interaction in vivo of montelukast and rosiglitazone (metabolized with the participation of the cytochrome system CYP2C8 isoenzyme), there was no evidence of montelukast CYP2C8 isoenzyme inhibition. Therefore, in clinical practice, montelukast is not supposed to affect CYP2C8-mediated metabolism of a number of drugs, including Paclitaxel, rosiglitazone, repaglinide, etc.

In vitro studies have shown that montelukast is a substrate of pZofermept CYP2C8, 2C9 and 3A4. Clinical research data on drug interactions for montelukast and gemfibrozil (an inhibitor like CYP2C8.and 2C9) demonstrate that gemfibrozil increases the effect of the systemic effect of montelukast 4.4 times. Joint reception of itraconazole. a strong inhibitor of the isoenzyme CYP3A4, 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 one week were not observed clinically significant adverse effects). 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

Montelukast is a valid supplement to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. When therapeutic effect is achieved during montelukast therapy, a gradual reduction in the dose of bronchodilators can be started.

Combined treatment with inhaled corticosteroids

The treatment with moutelucast provides an additional therapeutic effect to patients using inhaled GCS. With the achievement of stabilization of the patient's condition, you can begin a gradual reduction in the dose of GCS under the supervision of a physician. In some cases, complete elimination of inhaled GCS is permissible, however, abrupt replacement of inhaled GCS with montelukast is not recommended.

Terms and conditions of storage

The preparation should be stored in a dark place, out of the reach of children, at a temperature not exceeding 25 ° C.