Montelar, 10 mg, film-coated tablets, 14 pcs.
Montelukast can be prescribed together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma, such as bronchodilators and inhaled corticosteroids. 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, digoxin and warfarin.
The AUC value decreases in individuals concomitantly receiving phenobarbital (by approximately 40%), however, no adjustment of the montelukast dosage regimen is required in such patients. in vitro studies
It has been shown that montelukast is a potential inhibitor of the CYP2C8 isoenzyme of the cytochrome P450 system, however, data from clinical studies of drug-drug interactions, including montelukast and rosiglitazone (a preliminary substrate of a representative of medications primarily metabolized by the CYP2C8 isoenzyme) showed that doses of montelukast do not inhibit the CYP2C8 isoenzyme
in vivo
. Therefore, montelukast does not have a significant effect on the metabolism of medications metabolized by this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).
In vitro studies
showed that montelukast is a substrate of CYP2C8, CYP2C9 and CYP3A4. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both CYP2C8 and CYP2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times.
Co-administration of intraconazole, a strong CYP3A4 inhibitor, with gemfibrozil and montelukast did not result in an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic exposure of montelukast may not be considered clinically significant based on safety data when used at doses higher than the approved dose of 10 mg in adults (e.g., 200 mg/day for adults for 22 weeks and up to 900 mg/day - no clinically significant adverse effects were observed for patients taking the drug for approximately one week).
Therefore, no dosage adjustment of montelukast is required when coadministered with gemfibrozil.
Based on in vitro
There are no clinically significant drug interactions expected with other known CYP2C8 inhibitors (for example, trimethoprim). In addition, coadministration of montelukast with intraconazole alone did not significantly increase the effect of systemic exposure to montelukast.
Combination treatment with bronchodilators
Montelar® is a reasonable addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. Once a therapeutic effect has been achieved (usually after the first dose) from treatment with Montelar®, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled corticosteroids
Treatment with Montelar® provides an additional therapeutic effect to 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 Montelar® is not recommended.
Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised, especially in children over 15 years of age, if montelukast is co-administered with drugs that induce the CYP3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.
Montelar, 28 pcs., 5 mg, chewable tablets
Montelukast can be prescribed together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma, such as bronchodilators and inhaled corticosteroids. 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, digoxin and warfarin.
The AUC value decreases in individuals concomitantly receiving phenobarbital (by approximately 40%), however, no adjustment of the montelukast dosage regimen is required in such patients. in vitro studies
It has been shown that montelukast is a potential inhibitor of the CYP2C8 isoenzyme of the cytochrome P450 system, however, data from clinical studies of drug-drug interactions, including montelukast and rosiglitazone (a preliminary substrate of a representative of medications primarily metabolized by the CYP2C8 isoenzyme) showed that doses of montelukast do not inhibit the CYP2C8 isoenzyme
in vivo
. Therefore, montelukast does not have a significant effect on the metabolism of medications metabolized by this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).
In vitro studies
showed that montelukast is a substrate of CYP2C8, CYP2C9 and CYP3A4. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both CYP2C8 and CYP2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times.
Co-administration of intraconazole, a strong CYP3A4 inhibitor, with gemfibrozil and montelukast did not result in an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic exposure of montelukast may not be considered clinically significant based on safety data when used at doses higher than the approved dose of 10 mg in adults (e.g., 200 mg/day for adults for 22 weeks and up to 900 mg/day - no clinically significant adverse effects were observed for patients taking the drug for approximately one week).
Therefore, no dosage adjustment of montelukast is required when coadministered with gemfibrozil.
Based on in vitro
There are no clinically significant drug interactions expected with other known CYP2C8 inhibitors (for example, trimethoprim). In addition, coadministration of montelukast with intraconazole alone did not significantly increase the effect of systemic exposure to montelukast.
Combination treatment with bronchodilators
Montelar® is a reasonable addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. Once a therapeutic effect has been achieved (usually after the first dose) from treatment with Montelar®, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled corticosteroids
Treatment with Montelar® provides an additional therapeutic effect to 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 Montelar® is not recommended.
Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised, especially in children over 15 years of age, if montelukast is co-administered with drugs that induce the CYP3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.
Montelar film-coated tablets 10 mg 14 pcs. in Moscow
Montelukast can be prescribed together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma, such as bronchodilators and inhaled corticosteroids. 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/norethinsterone 35/1), terfenadine, digoxin and warfarin.
The AUC value decreases in individuals concomitantly receiving phenobarbital (by approximately 40%), however, no adjustment of the montelukast dosage regimen is required in such patients. in vitro studies
It has been shown that montelukast is a potential inhibitor of the CYP2C8 isoenzyme of the cytochrome P450 system, however, data from clinical studies of drug-drug interactions, including montelukast and rosiglitazone (a preliminary substrate of a representative of medications primarily metabolized by the CYP2C8 isoenzyme) showed that doses of montelukast do not inhibit the CYP2C8 isoenzyme
in vivo
. Therefore, montelukast does not have a significant effect on the metabolism of medications metabolized by this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).
In vitro studies
showed that montelukast is a substrate of CYP2C8, CYP2C9 and CYP3A4. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both CYP2C8 and CYP2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times.
Co-administration of intraconazole, a strong CYP3A4 inhibitor, with gemfibrozil and montelukast did not result in an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic exposure of montelukast may not be considered clinically significant based on safety data when used at doses higher than the approved dose of 10 mg in adults (e.g., 200 mg/day for adults for 22 weeks and up to 900 mg/day - no clinically significant adverse effects were observed for patients taking the drug for approximately one week).
Therefore, no dosage adjustment of montelukast is required when coadministered with gemfibrozil.
Based on in vitro
There are no clinically significant drug interactions expected with other known CYP2C8 inhibitors (for example, trimethoprim). In addition, coadministration of montelukast with intraconazole alone did not significantly increase the effect of systemic exposure to montelukast.
Combination treatment with bronchodilators
Montelar® is a reasonable addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. Once a therapeutic effect has been achieved (usually after the first dose) from treatment with Montelar®, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled corticosteroids
Treatment with Montelar® provides an additional therapeutic effect to 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 Montelar® is not recommended.
Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised, especially in children over 15 years of age, if montelukast is co-administered with drugs that induce the CYP3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.
Montelar
It is recommended to continue taking the drug after achieving significant improvement. The drug is not recommended for the treatment of acute attacks of bronchial asthma. In acute cases of bronchial asthma, patients should use emergency medications to relieve attacks (short-acting inhaled beta2-agonists).
Reducing the systemic dose of glucocorticosteroids (GCS) in patients receiving anti-asthmatic drugs, including leukotriene receptor antagonists, was accompanied in rare cases by the development of Churg-Strauss syndrome (systemic eosinophilic vasculitis), manifested in the form of eosinophilia, vascular rash, increased severity of pulmonary symptoms and, in the absence of proper treatment, cardiac complications and/or neuropathy. Although a cause-and-effect relationship between these adverse events and leukotriene receptor antagonist therapy has not been established, with a decrease in systemic
doses of GCS in patients taking montelukast, caution must be exercised and appropriate clinical monitoring must be carried out.
The dose of corticosteroids used together with montelukast should be reduced gradually, under the supervision of a physician. It is not recommended to abruptly replace therapy with inhaled or oral corticosteroids by prescribing the drug. Patients with a confirmed allergy to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs should avoid contact with these drugs during treatment, since montelukast, while improving respiratory function in patients with allergic bronchial asthma, nevertheless does not prevent bronchoconstriction caused by the action of NSAIDs.
When reducing the systemic dose of GCS in patients taking the drug, caution must be exercised and appropriate clinical monitoring must be carried out.
Patients with phenylketonuria should be informed that 1 chewable 4 mg tablet contains at least 0.96 mg of aspartame, and 1 chewable 5 mg tablet contains at least 1.20 mg of aspartame.
Chewable tablets contain charming red dye (Allura red), which can cause allergic reactions.
There is no data on the effect of the drug on the ability to drive vehicles and operate machinery. However, drowsiness and dizziness have been reported, so patients who experience these symptoms are not advised to drive or operate machinery.
