Montelukast-Teva 4mg 28 chewable tablets — Made in Poland — Free Delivery

(Montelukast-Teva )

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Description Montelukast-Teva 4mg 28 chewable tablets — Made in Poland — Free Delivery

Pharmacological properties

Pharmacodynamics. Cysteinyl leukotrienes (ltc4, ltd4, lte4) are potent inflammatory eicosanoids that are secreted by a variety of cells, including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (cyslt) in the human respiratory tract and cause reactions such as bronchospasm, sputum production, increased vascular permeability and increased eosinophil count.

Montelukast is an active compound that binds with high selectivity and chemical affinity to CysLT1 receptors. Montelukast causes significant blocking of cysteinyl leukotriene receptors in the airways, which was confirmed by its ability to inhibit bronchoconstriction in AD patients caused by inhalation of LTD4. Even a low dose of 5 mg causes significant blockade of LTD4-stimulated bronchoconstriction. Montelukast causes bronchodilation within 2 hours after oral administration; this effect was additive to the bronchodilation induced by β-adrenergic receptor agonists.

In adult patients and children aged 2–14 years, montelukast, in comparison with placebo, reduces the number of peripheral blood eosinophils and improves the clinical control of asthma.

In studies involving adults, montelukast at a dose of 10 mg 1 time per day compared with placebo showed a significant improvement in morning fixed expiratory volume, morning maximum expiratory flow rate and a significant decrease in the total use of β-adrenergic receptor agonists. The patient's reported indicators of a decrease in the severity of day and night symptoms of asthma were significantly better than those for placebo.

Studies in adults have demonstrated the ability of montelukast to complement the clinical effect of inhaled corticosteroids. Compared with inhaled beclomethasone (200 mcg twice daily, spacer device), montelukast showed a faster initial response, although beclomethasone resulted in a more pronounced average therapeutic effect during the 12-week study. However, compared with beclomethasone, a greater number of patients treated with montelukast achieved a similar clinical response.

Montelukast and fluticasone also improved AD control relative to secondary variables assessed over a 12-month treatment period.

A significant reduction in exercise-related bronchospasm (EIB) was demonstrated in a 12-week adult study. This effect was observed over the 12-week study period. A decrease in EIB was also demonstrated in a short study in children aged 6-14 years. The effect in both studies was demonstrated at the end of the interval when taken once a day.

Treatment with montelukast suppresses bronchospasm both in the early and late stages, reducing the response to antigens. Montelukast, compared with placebo, reduces the number of peripheral blood eosinophils in adults and children. In a separate study, when taking montelukast, the number of eosinophils in the airways (as measured by sputum) and in the peripheral blood significantly decreased, which improved the clinical control of asthma.

Pharmacokinetics

Absorption. After oral administration, montelukast is rapidly and almost completely absorbed.

After consumption on an empty stomach, the preparation in the form of chewable tablets at a dose of 5 mg Cmax is achieved after 2 hours. The average bioavailability is 73% and decreases to 63% after meals.

After taking the preparation in the form of chewable tablets at a dose of 4 mg on an empty stomach, Cmax in children aged 2–5 years is achieved after 2 hours. Cmax is 66% higher and Cmin is lower compared to the values obtained for adults when taking 10 mg tablets.

After taking the preparation in the form of tablets, 10 mg on an empty stomach, Cmax in blood plasma is reached after 3 hours (Tmax). The average bioavailability is 64%. Regular food intake does not affect plasma Cmax and bioavailability. Safety and efficacy have been demonstrated in clinical trials in groups where 10 mg film-coated tablets were taken with or without food.

Distribution. More than 99% of montelukast binds to plasma proteins. The volume of distribution of montelukast in the stationary phase averages 8–11 liters. In animal studies, the passage of radioisotope-labeled montelukast across the blood-brain barrier was minimal. In all other tissues, the concentration of the radioisotope-labeled material was also minimal 24 hours after the dose was administered.

Metabolism. Montelukast is extensively metabolized. In studies with therapeutic doses, steady-state plasma concentrations of montelukast metabolites in adults and pediatric patients are not determined.

In vitro studies using human liver microsomes have shown that CYP 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast. Based on the results of further studies of human liver microsomes in vitro, it was shown that at therapeutic concentrations montelukast does not suppress CYP 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6. The participation of metabolites in the therapeutic effect of montelukast is minimal.

Excretion. The clearance of montelukast from blood plasma of healthy adult volunteers averages 45 ml / min. After oral administration of isotope-labeled montelukast, 86% is excreted in the feces within 5 days and less than 0.2% in the urine. Together with the oral bioavailability of montelukast, this fact indicates that its metabolites are almost completely excreted in the bile.

Pharmacokinetics in different patient groups. For elderly patients, as well as for patients with mild to moderate hepatic insufficiency, dose adjustment is not required. Application studies in patients with renal insufficiency have not been conducted. Since montelukast and its metabolites are excreted in the bile, dose adjustment for patients with renal insufficiency is not considered necessary. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic impairment (more than 9 points on the Child-Pugh scale).

When montelukast was taken in high doses (which were 20 and 60 times higher than the dose recommended for adults), a decrease in the concentration of theophylline in blood plasma was observed. This effect was not observed when taking the recommended dose of 10 mg 1 time per day.

Indications

4 mg montelukast-teva chewable tablets are recommended for children aged 2–5 years; chewable tablets montelukast-teva 5 mg are recommended for children 6-14 years old:

as an additional treatment for asthma in patients with persistent asthma of mild and moderate severity, which is insufficiently controlled by inhaled corticosteroids, as well as in case of insufficient clinical control of asthma with the help of short-acting β-adrenergic receptor agonists, used if necessary;

as an alternative method of treatment in relation to low doses of inhaled corticosteroids in patients with persistent mild asthma who have not recently had serious attacks of asthma requiring oral administration of corticosteroids, as well as for those patients who have been diagnosed with intolerance to inhaled corticosteroids;

prophylactically before physical activity to prevent an asthmatic attack.

Montelukast-Teva, tablets 10 mg. Additional treatment of persistent asthma of mild and moderate degree, which is insufficiently controlled by inhaled corticosteroids, as well as in case of insufficient clinical control of asthma with the help of short-acting β-adrenergic receptor agonists, used if necessary.

Symptomatic treatment of seasonal allergic rhinitis in BA patients.

For the prevention of exercise-induced asthmatic attacks.

Application

Montelukast-teva chewable tablets, 4 or 5 mg. the preparation should be used in children under adult supervision.

Children aged 2–5 years. The recommended dose is 1 chewable tablet 4 mg / day, in the evening. Montelukast-Teva is taken 1 hour before or 2 hours after meals. For patients in this group, individual dose selection is not needed.

Children aged 6-14. The recommended dose is 1 chewable tablet 5 mg / day, in the evening. Montelukast-Teva is taken 1 hour before or 2 hours after meals. For patients in this group, individual dose selection is not needed.

For patients over the age of 15, it is recommended to use Montelukast-Teva, film-coated tablets, 10 mg.

Montelukast-Teva, film-coated tablets, 10 mg. Montelukast Teva can be taken with food or alone.

The recommended dose for patients aged 15 years and older is 1 tablet 10 mg / day, in the evening.

General recommendations. The therapeutic effect of Montelukast-Tev on BA control indicators is manifested within 1 day. Patients are advised to continue using Montelukast-Teva, even if asthma is under control, just as during its exacerbation.

It is not recommended to use Montelukast-Teva simultaneously with other preparations that contain the same active substance - montelukast.

No dose adjustment is required in patients with renal insufficiency, as well as mild to moderate liver dysfunction. There is no data on the use of the preparation in patients with severe liver dysfunction.

The dosage is the same for men and women.

Alternative therapy with low doses of inhaled corticosteroids in patients with persistent mild asthma. Montelukast-Teva is not recommended as monotherapy for patients with moderate persistent asthma. The use of montelukast as an alternative treatment with low doses of inhaled corticosteroids in children with persistent mild asthma is recommended only for patients who have not recently had serious attacks of asthma, who required oral administration of corticosteroids, and who have been found to be intolerant of inhaled corticosteroids. Mild persistent asthma is asthma with symptoms more than 1 time per week, but less than 1 time per day, nocturnal attacks more than 2 attacks per month, but less than 1 time per week, between attacks - the normal functioning of the lungs is protected.

If satisfactory BA control is not achieved after treatment (usually within 1 month), consideration should be given to the need for additional or other anti-inflammatory therapy based on a stepwise BA treatment system. BA control in patients should be periodically assessed.

Prevention of exercise-induced asthma. In children, exercise-induced bronchospasm may be the dominant indicator of persistent asthma, and requires treatment with inhaled corticosteroids. Patients should be evaluated after 2–4 weeks of treatment with Montelukast-Teva. If a satisfactory response to therapy is not achieved, additional treatment should be considered.

Treatment of Montelukast-Teva in relation to other methods of BA therapy. Montelukast-Teva therapy can be added to the patient's existing regimen. Treatment with Montelukast-Teva can be used as an adjunct when other preparations, such as inhaled corticosteroids, used if necessary, do not provide enough clinical control over asthma. When montelukast treatment is an auxiliary therapy when taking inhaled corticosteroids, Montelukast-Teva cannot be abruptly replaced with inhaled corticosteroids.

Children. The dpreparation ug in the form of chewable tablets is not recommended for use in children under 2 years of age. The preparation in the form of coated tablets, 10 mg is not recommended for use in children under 15 years of age.

Contraindications

Hypersensitivity to montelukast or to any component of the preparation.

Montelukast-Teva, chewable tablets, 4 or 5 mg: children under 2 years of age.

Montelukast-Teva, film-coated tablets, 10 mg: children under 15 years of age.

Side effects

Adverse reactions reported during clinical trials

From the side of the central nervous system: headache.

General: feeling of thirst.

From the digestive system: abdominal pain.

The following adverse reactions have been reported in the post-marketing period

Infections and infestations: upper respiratory tract infections.

From the hematopoietic system: an increased tendency to bleeding.

From the immune system: hypersensitivity, including anaphylaxis, eosinophilic liver infiltration.

Mental disorders: sleep disorders, including nightmares, hallucinations, disorientation, insomnia, somnambulism, psychomotor hyperactivity (irritability, anxiety, agitation, including aggressive behavior or hostility, tremors), depression, suicidal thoughts and behavior (suicidal attempts).

From the side of the central nervous system: lethargy and dizziness, drowsiness, paresthesia / hypoesthesia, convulsions.

On the part of the cardiovascular system: palpitations.

From the respiratory system: epistaxis.

From the digestive system: diarrhea, dry mouth, dyspepsia, nausea, vomiting.

From the hepatobiliary system: an increase in the level of blood plasma transaminases (ALT, ASAT), hepatitis (including cholestatic, hepatocellular and mixed liver damage).

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

From the musculoskeletal system and connective tissue: arthralgia, myalgia, including muscle cramps.

General: asthenia / fatigue, fever, discomfort, edema.

During the treatment of BA patients with montelukast, the occurrence of the Churg-Strauss syndrome has been described.

Special instructions

Patients should be warned that montelukast-teva should not be used to relieve acute attacks of ba. it is recommended to continue treatment with the usual appropriate medication for relieving seizures. in the event of an acute attack, short-acting inhaled β-agonists should be used. patients need to consult a doctor as soon as possible if they need more than usual inhalations of short-acting β-agonists.

You should not abruptly replace montelukast therapy with inhaled or oral corticosteroids.

There is no data that would prove that the intake of oral corticosteroids can be reduced with the simultaneous use of montelukast.

The occurrence of neuropsychiatric events has been reported in patients taking Montelukast-Teva (see SIDE EFFECTS). Since these phenomena may be influenced by other factors, it is not known whether they are associated with the use of the preparation Montelukast-Teva. Physicians should discuss these adverse events with their patients and / or their caregivers. Patients and / or caregivers should be instructed to inform their physician when such changes occur.

In rare cases, patients receiving anti-asthma preparations, including montelukast, may experience systemic eosinophilia, sometimes together with clinical manifestations of vasculitis, the so-called Churge-Strauss syndrome (granulomatous allergic angiitis), which is treated with systemic GCS. Such cases were usually (but not always) associated with dose reduction or withdrawal of GCS therapy. The likelihood that leukotriene receptor antagonists may be associated with the emergence of Churg-Strauss syndrome cannot be refuted or confirmed, so doctors should be warned about the possibility of eosinophilia, vasculitis rash, worsening pulmonary symptoms, heart complications and / or neuropathy in patients. ... Patients who develop the aforementioned symptoms should be re-evaluated and their treatment regimen should be reviewed.

Treatment with montelukast does not allow patients with aspirin-dependent asthma to use acetylsalicylic acid or other NSAIDs.

Montelukast-Teva chewable tablets contain aspartame, which is a source of phenylalanine. Patients with phenylketonuria should take into account that each 5 mg tablet contains phenylalanine.

Monetukast-Teva in the form of film-coated tablets, 10 mg, should not be used in patients with rare hereditary diseases: galactose intolerance, lactose deficiency or malabsorption of glucose and galactose.

Use during pregnancy or breastfeeding

Pregnancy. Animal studies have shown no adverse effects on pregnancy or fetal development.

Limited data from global marketing experience have not revealed a causal relationship between rare cases of congenital limb defects in children whose mothers took montelukast during pregnancy and taking the preparation.

Montelukast-Teva can be taken during pregnancy only when, in the opinion of the doctor, the expected benefit to the mother outweighs the possible risk to the fetus.

Breastfeeding period. Animal studies have shown that montelukast passes into breast milk. It is not known whether montelukast passes into human breast milk.

Therefore, Montelukast-Teva can be taken during breastfeeding when, in the opinion of the doctor, the expected benefit to the mother outweighs the possible risk to the child.

The ability to influence the reaction rate when driving vehicles or other mechanisms. The influence of montelukast on the ability to drive vehicles or operate other mechanisms is not expected. However, in very rare cases, some patients may experience dizziness or drowsiness.

Interactions

Montelukast-Teva can be prescribed together with other preparations for the prevention or long-term treatment of BA. when studying preparation interactions, the recommended dose of montelukast did not have a significant clinical effect on the pharmacokinetics of the following preparations : theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol / norethindrone 35/1), terfenadine, digoxin and warfarin.

In patients who were simultaneously taking phenobarbital, the AUC for montelukast decreased by about 40%. Since montelukast is metabolized by CYP 3A4, 2C8 and 2C9, care must be taken, especially in children, if montelukast is administered concomitantly with CYP inducers 3A4, 2C8 and 2C9, such as phenytoin, phenobarbital and rifampicin.

In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical study of the interaction of preparations, including montelukast and rosiglitazone (a preparation metabolized by CYP 2C8), showed that montelukast is not an inhibitor of CYP 2C8 in vivo. Thus, montelukast does not significantly affect the metabolism of preparations that are metabolized by this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).

During in vitro studies, it was found that montelukast is a substrate for CYP 2C8 and to a lesser extent 2C9 and 3A4. In a clinical study of preparation interactions using montelukast and gemfibrozil (an inhibitor of CYP 2C8 and 2C9), gemfibrozil increased the systemic exposure of montelukast by 4.4 times. When used simultaneously with gemfibrozil or other potent inhibitors of CYP 2C8, dose adjustment of montelukast is not necessary, but the doctor should take into account the increased risk of adverse reactions.

Based on the results of in vitro studies, clinically important interactions with less potent inhibitors of CYP 2C8 (for example, with trimethoprim) are not expected. The simultaneous use of montelukast with itraconazole, a strong inhibitor of CYP 3A4, did not lead to a significant increase in the systemic exposure of montelukast.

Overdose

There is no specific information on the treatment of montelukast overdose.

In studies of chronic BA, montelukast was prescribed in doses up to 200 mg / day to adult patients for 22 weeks, and in short-term studies - up to 900 mg / day for about 1 week, there were no clinically significant adverse reactions.

With post-marketing use and in clinical studies, there have been reports of acute overdose of the preparation montelukast. These data included taking the preparation in adults and children in doses greater than 1000 mg (approximately 61 mg / kg, child aged 42 months). The clinical and laboratory data obtained were consistent with the safety profile for adults and children.

In most reports of cases of overdose, no side effects were observed. The most commonly reported side effects were consistent with the safety profile of the preparation and included abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity.

It is not known whether montelukast is excreted by peritoneal dialysis or hemodialysis. Treatment is symptomatic.

Storage conditions

Montelukast-teva, chewable tablets, 4 or 5 mg: at a temperature not exceeding 30 ° C in the original packaging to protect from light.

Tags: Montelukast

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