Active substanceMontelukastMontelukast Similar drugsTo uncover Almonte pills inwards Actavis PTS ehf Group Iceland Almonte pills inwards Actavis PTS ehf Group Iceland Glemont pills inwards Glenmark Pharmaceuticals Co., Ltd. India Monax® pills inwards Zentiva Saalyk Yuryunleri Sanayi ve Tidjaret A.Sh. Turkey Monax® pills inwards Zentiva Saalyk Yuryunleri Sanayi ve Tidjaret A.Sh. Turkey Moncasta® pills inwards KRKA-RUS, LLC Russia Moncasta® pills inwards KRKA-RUS, LLC Russia Montler® pills inwards Beluga, medicines and cosmetics. Croatia Montler® pills inwards Beluga, medicines and cosmetics. Croatia Montelar pills inwards Sandoz d. Slovenia Montelar pills inwards Sandoz d. Slovenia Montelukast pills inwards VERTEKS, AO Russia Montelukast pills inwards VERTEKS, AO Russia Montelukast pills inwards MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia Montelukast pills inwards MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia Montelukast pills inwards Heterose Labs Limited India Singlon® pills inwards GEDEON RICHTER, OJSC Hungary Singlon® pills inwards GEDEON RICHTER, OJSC Hungary Singlon® pills inwards GEDEON RICHTER, OJSC Hungary Singular® pills inwards Merck Sharp and Doum B.V. Netherlands Singular® pills inwards Merck Sharp and Doum B.V. Netherlands Singular® pills inwards Merck Sharp and Doum B.V. Netherlands Ektalust® pills inwards CANONFARMA PRODUCTION, CJSC Russia Ektalust® pills inwards CANONFARMA PRODUCTION, CJSC Russia Dosage form: & nbspFilm coated tablets. Composition:For 1 tablet covered with a film sheath:Core tablet:Active substance: Montelukast sodium 10,4 mg (equivalent to 10 mg montelukast). Excipients: lactose monohydrate 89.3 mg, cellulose microcrystalline 101 89.3 mg, giprolose 4.0 mg, croscarmellose sodium 6.0 mg, magnesium stearate 1.0 mg.Sheath: Fill yellow 20B32427 5.0 mg (hypromellose 3aR 1.750 mg, giprolose 1.500 mg, titanium dioxide 0.925 mg, macrogol 400 0.500 mg, hypromellose 50cR 0.250 mg, iron oxide dye yellow 0.075 mg). Description:Round biconvex tablets covered with a film coating of yellow color; on one side the engraving "R" and the number 15 under the letter "R". On the cross-section the nucleus is white. Pharmacotherapeutic group:Anti-inflammatory anti-bronchoconstrictive means - leukotriene receptor blocker. ATX: & nbspR.03.D.C.03 Montelukast Pharmacodynamics:Montelukast - a specific antagonist of leukotriene receptors for oral administration. Montelukast has the ability to inhibit bronchospasm due to the inhalation of LTD4 in very low doses (5 mg). Bronchodilation is observed within 2 hours after ingestion. The effect of bronchodilation, caused by beta-adrenomimetic, is supplemented by the action of montelukast. Montelukast inhibits the early and late phases of bronchospasm caused by the administration of the antigen. Montelukast reduces the number of eosinophils in the peripheral blood, in the respiratory tract (in sputum) of adult patients and children and improves control over the course of bronchial asthma.Montelukast significantly improves the morning FEV (volume of forced exhalation) for 1 second, MOSV (maximum volumetric expiratory flow rate) and significantly reduces the need for beta-adrenomimetics.Montelukast enhances the effect of inhaled glucocorticosteroids. Montelukast significantly reduces bronchospasm, which occurs against the background of physical exertion. In patients with bronchial asthma, sensitive to acetylsalicylic acid and taking concomitant inhalation and / or oral glucocorticosteroids,treatment with montelukast leads to a significant improvement in the control of symptoms of bronchial asthma. Pharmacokinetics:AbsorptionMontelukast is rapidly absorbed after oral administration. In adults, when taking 10 mg of montelukast on an empty stomach, the maximum concentration (Cmax) in plasma is reached after 3 hours. On average, the bioavailability after oral administration is 64%. Food intake does not affect the bioavailability and Cmax montelukast.Montelukast is more than 99% bound to plasma proteins. The volume distribution of Montelukast in the equilibrium state averages 8-11 liters. The drug penetrates poorly through the blood-brain barrier. Concentrations of montelukast 24 hours after application of the drug were minimal in all tissues of the body. BiotransformationMontelukast undergoes intensive metabolism. When therapeutic doses are used, the concentration of metabolites of montelukast in plasma in equilibrium in adults and children is not determined. It is assumed that the metabolism of montelukast involves cytochrome P450 isoenzymes ZA4, 2A6 and 2C9, while in therapeutic concentrations montelukast does not inhibit cytochrome P450 isoenzymes P450, 4C9, 1A2, 2A6, 2C19 and 2D6. The contribution of metabolites to the therapeutic effect of montelukast is minimal.ExcretionPlasma clearance of montelukast in healthy adults is an average of 45 ml / min. After taking montelukast, 86% of the drug is taken out through the intestine and less than 0.2% by the kidneys. The drug and its metabolites are excreted mainly with bile. Pharmacokinetics in different patient groupsFor the elderly, patients with mild or moderate hepatic insufficiency, dose adjustment is not required. Studies in patients with renal insufficiency have not been conducted. Because the montelukast and its metabolites are excreted in bile, no dose adjustment is required for patients with renal insufficiency. Data on the pharmacokinetics of montelukast in patients with severe hepatic impairment (score> 9 on the Child-Pugh scale) are not available. Indications:- long-term treatment and prevention of bronchial asthma (including prevention of day and night symptoms of the disease);- treatment of "aspirin" asthma and prevention of bronchospasm of physical effort. Contraindications:- Hypersensitivity to the active substance or to any of the excipients.- Children under 15 years.- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Carefully:Pregnancy and lactation. Pregnancy and lactation:The drug Singlon® can be used during pregnancy and during lactation if the expected benefit for the mother exceeds the potential risk to the fetus and the baby. Dosing and Administration:Inside.Adults and adolescents aged 15 years and older for the treatment of bronchial asthma, taken orally one tablet of the drug Singlon® 10 mg daily in the evening regardless of the meal.General recommendations:The therapeutic effect of the drug Singlon® on the symptoms associated with bronchial asthma manifests itself within one day. The patient is advised to continue taking Singlon® both during periods of controlled asthma and during periods of worsening of the course of the disease.The preparation Singlon® should not be taken together with other drugs containing the same active substance - montelukast.In elderly patients with mild or moderate renal insufficiency, hepatic insufficiency does not require correction of the dose. Data for patients with severe hepatic insufficiency are absent.The dose of the drug is the same for both female and male patients.The preparation Singlon® can be included in existing regimens for the treatment of bronchial asthma.Inhaled glucocorticosteroids: Singlon® is prescribed for the treatment of bronchial asthma as adjunctive therapy for patients in whom inhaled glucocorticosteroids and short-acting beta-adrenomimetics, if necessary, do not provide the necessary clinical control of the disease. Montelukast should not replace inhaled glucocorticosteroids.For children aged 6 to 14 years, 5 mg of chewable tablets are used. Side effects:Violations from the blood and lymphatic system: increased tendency to bleeding.Immune system disorders: hypersensitivity reactions, including anaphylaxis; eosinophilic liver infiltrates.Disorders of the psyche: sleep disturbances, including nightmares, hallucinations, insomnia; irritability, anxiety, agitation, including aggressive behavior, tremor, depression, suicidal ideation and suicidal behavior (suicidality).Impaired nervous system: headache, dizziness, drowsiness, paresthesia / hypesthesia, convulsive seizures.Heart Disease: cardiopalmus.Disorders from the gastrointestinal tract: abdominal pain, diarrhea, dry mouth, indigestion, nausea, vomiting.Disorders from the hepatobiliary system: increased activity of transaminases in the blood serum (alanine aminotransferase, aspartate aminotransferase), cholestatic hepatitis.Disturbances from the skin and subcutaneous tissues: angioedema, appearance of ecchymosis, urticaria, pruritus, rash, nodular erythema.Disturbances from the musculoskeletal system and connective tissue: arthralgia, myalgia, including muscle spasms.General disorders and disorders at the site of administration: thirst, asthenia / increased fatigue, discomfort, swelling.There have been reports of cases of the development of the Charge-Strauss syndrome (systemic eosinophilic vasculitis) in patients suffering from bronchial asthma, while receiving montelukast. Overdose:There is no specific information on the treatment of overdose with Singlon®. Data on symptoms of an overdose when taking the drug by adults with bronchial asthma at a dose exceeding 200 mg per day for 22 weeks and at a dose of 900 mg per day for 1 week has not been revealed.There have been cases of acute overdose of montelukast in adults and children at a dose above 1000 mg (approximately 61 mg / kg for a child aged 42 months). The clinical and laboratory results obtained were consistent with the safety profile for adults and pediatric patients. The most common adverse events were consistent with the safety profile of montelukast and included abdominal pain, drowsiness, mydriasis, thirst, headache, vomiting and psychomotor hyperactivity.There is no data on the possibility of removing montelukast for peritoneal dialysis or hemodialysis. Interaction:The preparation Singlon® can be appointed together with other drugs traditionally prescribed for the prevention and long-term treatment of bronchial asthma. The drug at recommended doses had no clinically significant effect on the pharmacokinetics of the following drugsmeans: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethisterone 35/1), terfenadine, digoxin and warfarin.The area under the concentration-time curve (AUC) of Montelukast in plasma decreased by about 40% in patients who took montelukast and phenobarbital. Since CYP-α4 is involved in the metabolism of montelukast, caution should be exercised, especially in children, when using montelukast with CYP α4 inducers such as phenytoin, phenobarbital and rifampicin.In vitro studies it was found that montelukast is a potent inhibitor of CYP 2C8. However, the results of a study of the clinical interaction of montelukast and rosiglitazone (an example of marker substrates for drugs whose basic metabolism is carried out by the CYP 2C8 enzyme) did not reveal the inhibitory effect of montelukast on CYP 2C8 in vivo. Therefore, it is expected that montelukast will not besignificantly change the transformation of drugs that are metabolized with the participation of this enzyme (for example, paclitaxel, rosiglitazone and repaglinide).When taking high doses of montelukast (at a 20- and 60-fold excess of the recommended dose for adults), a decrease in the concentration of theophylline in the plasma is observed.This effect is not observed when taking the drug at recommended doses - 10 mg per day. Special instructions:The drug Singlon® should not replace inhaled or oral glucocorticosteroids.There are no data indicating the possibility of reducing the dose of oral glucocorticosteroids with the concomitant use of the Singlon® preparation.In rare cases, patients receiving bronchial asthma medications, including Singlon®, may experience systemic eosinophilia, sometimes accompanied by clinical manifestations of vasculitis and Charge-Strauss syndrome; this condition is usually treated with systemic glucocorticosteroids. Such cases are usually, but not always, associated with a decrease in dose or with the elimination of oral glucocorticosteroids. We can neither exclude nor confirm the possibility that the administration of leukotriene receptor antagonists may be associated with the onset of the Chang-Strauss syndrome. Doctors should be aware of the possibility of patients developing eosinophilia, vasculitic rash, an increase in pulmonary symptoms, complications from the heart and / or neuropathy.Patients who have the above symptoms should undergo a second examination, and their treatment regimen should be reviewed.Receiving Synngon® does not affect the intake of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs in patients with bronchial asthma with increased sensitivity to acetylsalicylic acid.The drug contains lactose, so it should not be taken to patients with such rare hereditary diseases as lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Effect on the ability to drive transp. cf. and fur:It is assumed that the preparation Singlon ® does not affect the ability to drive or other mechanisms. However, in very rare cases, patients were drowsy. Form release / dosage:Film-coated tablets, 10 mg. Packaging:For 7 tablets in a blister Al / Al. For 2, 4 or 8 blisters in a cardboard box together with instructions for use. Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C.Inaccessible to children! Shelf life:2 years.Do not use after the expiry date printed on the package. Terms of leave from pharmacies:On prescription Registration number:LP-001490 Date of registration:08.02.2012 Expiration Date:08.02.2017 The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary Manufacturer: & nbspGEDEON RICHTER POLAND, Co. Ltd. Poland Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary Information update date: & nbsp2016-10-18 Illustrated instructions × Illustrated instructions Instructions