The instruction for medical use of Mutsitus Torgovoye medicine a name Mutsitus Mezhdunarodnoye the unlicensed name Erdostein Lekarstvennaya a form of the Capsule of 150 mg and 300 mg Structure One capsule contains active agent - erdostein 150 mg and 300 mg, excipients: cellulose microcrystalline (PH-302), sodium of starch glikolit, magnesium stearate, K-30 povidone, structure of capsules No. 2 a lid: diamond blue (E 133), karmoizin (E 122), quinolinic yellow (E 104), the titan dioxide (E 171), the water purified sodium a lauryl sulfate, sodium methylparaben, sodium propylparaben, gelatin, the body: diamond blue (E 133), karmoizin (E 122), quinolinic yellow (E 104), the titan dioxide (E 171), the water purified sodium a lauryl sulfate, sodium methylparaben, sodium propylparaben, gelatin, structure of capsules No. 0 a lid: diamond blue (E 133), the titan dioxide (E 171), the water purified sodium a lauryl sulfate, sodium methylparaben, sodium propylparaben, gelatin, the body: the titan dioxide (E 171), the water purified sodium a lauryl sulfate, sodium methylparaben, sodium propylparaben, gelatin. The description Solid gelatin capsules, No. in size 2, with the body of azure color and a lid of brown color (for a dosage of 150 mg) Solid gelatin capsules, No. in size 0, with the body of whitish color and a lid of blue color (for a dosage of 300 mg) Contents of capsules – powder of white or whitish color. Pharmacotherapeutic group Respiratory system. The drugs used in cough and catarrhal diseases. Expektoranta, excepting combinations with suppressing cough. Mucolytics. Erdostein. The ATX R05CB15 code the Pharmacological Pharmacokinetics Quickly properties is absorbed in digestive tract and metabolized in a liver to three active metabolites, the most important of which – N-thiodiglycol-silt-gomotsistein (A metabolite 1 or M1). Semi-removal time - more than 5 hours. Repeated use of drug or meal do not influence pharmacokinetic parameters. The maximum concentration of drug – 3.46 mkg/ml, time of achievement of the maximum concentration of drug in blood plasma – 1.48 hours, the area under a curve concentration time (AUC) (0-24 hour) – 12.09. 64.5% of an erdostein contact proteins of blood plasma. Drug is removed in the form of inorganic sulfates through kidneys and with excrements. In case of an abnormal liver function the increase in indicators of the maximum concentration of drug and AUC is noted. Increase in time of semi-removal in the profound abnormal liver function is possible. In a renal failure the accumulation of metabolites is possible. The pharmacodynamics Erdostein is mucolytic means. All active metabolites of an erdostein cause a rupture of disulfide bridges which connect fibers of glycoproteins that leads to reduction of elasticity and viscosity of a phlegm. Secret discharge simplification from airways and increase in efficiency of a mukotsiliarny system which provides removal of slime and mucopurulent discharges from upper and lower parts of airways is result. Erdostein also reduces adhesive ability of gram-positive and gram-negative bacteria to an epithelium of airways. The antibacterial abhesive effect proved in the conditions of in vitro is capable to reduce formation of bacterial colonies and to reduce risk of emergence of bacterial superinfection. Erdostein antagonistic affects locally free radicals of oxygen, prevents their formation of 'in loco' and considerably reduces quantity 8 isopro-camp, a marker of peroxide oxidation of lipids. The anti-inflammatory effect of an erdostein in the conditions of in vitro and in vivo was also shown by reduction of formation of some protivospalitelny cytokines (IL-6, IL-8). Erdostein interferes with suppression alpha 1 - antitrypsin at tabakokurilshchik and by that reduces the damaging effect of tobacco smoke at chronic smokers. Erdostein increases concentration of immunoglobulin A in a mucous membrane of airways at patients with chronic obstructive respiratory diseases and also reduces overwhelming effect of tobacco smoke on function of granulocytes. At combined use erdostein increases concentration of amoxicillin in a bronchial secret therefore their combined use allows to receive the therapeutic answer quicker in comparison with monotherapy by amoxicillin. At patients with chronic obstructive respiratory diseases after 8-month treatment erdosteiny reduction of number of aggravations and improvement of quality of life is observed. The effect of therapy by drug develops for 3-4 days of treatment. Erdostein per se does not contain free SH groups therefore drug has no damaging effect on digestive tract and side effects from digestive system do not differ from effects of placebo. Indications - acute inflammatory respiratory diseases (rhinitis, sinusitis, a laryngopharyngitis, an acute bronchitis) - exacerbations of chronic respiratory diseases (chronic bronchitis, chronic obstructive diseases of lungs, hyper secretory asthma, a bronchoectatic disease, chronic bronchitis of the smoker (including seasonal aggravations) - complex therapy with antibiotics at exacerbations of bronchitis of a bacterial etiology - prevention of pneumonia and a partial atelectasis of lungs after surgical interventions. To Accept a route of administration and doses inside, washing down with enough water, to or at meal time. The recommended dose: 300 mg 2-3 times a day. Duration of treatment is defined by a condition of the patient and is defined by the doctor. At patients with a serious chronic illness of a liver the dose adjustment is necessary. In this case the recommended dose of 150 mg 2-3 times a day. Side effects Seldom - At elderly heartburn, nausea, diarrhea, pains in epigastriums, vomiting, a headache - allergic reactions: erubescence, a small tortoiseshell, a hyper pyrexia - an erythema, an itching, eczema Very seldom in an initiation of treatment - an ageusia (loss of flavoring sensitivity - it is temporary in an initiation of treatment) or a dysgeusia (change of flavoring sensitivity), dryness in the Contraindication mouth - hypersensitivity to the components which are a part of drug - an abnormal liver function (for example, in case of the increased level of alkaline phosphatase or transaminases, etc.) - a renal failure (clearance of creatinine & lt, 25 ml/min.) - a gomotsisteinuriya (drug is a source of a gomotsistein therefore disturbances of metabolism of amino acids at the patients who are on a diet with the reduced content of free methionine are possible) - children's and teenage age up to 18 years (in connection with presence of dye as a part of the capsule) Medicinal interactions At combined use of Mutsitus with other drugs which are used usually for treatment of respiratory infections and HOBL, for example, by theophylline bronchodilatory connections, erythromycin, amoxicillin or sulfametoprimy undesirable interactions were not observed. Erdostein exponentiates action of some antibiotics (for example, amoxicillin, a klaritromitsin) that can be used in the therapeutic purposes. Synergy interaction of drug with budesonidy and salbutamol is confirmed. Special instructions are not recommended to be accepted erdostein along with antibechic drugs as the accumulation of a liquid secret in bronchial tubes and increase in risk of development of superinfection or bronchospasm is possible. In a renal failure the accumulation of metabolites is possible. In the profound abnormal liver function the increase in time of semi-removal is possible. In the absence of positive dynamics within 5 days or deterioration is able, it is necessary to see the attending physician. Pregnancy and the period of a lactation also fetotoksichesky effects in preclinical trials were not noted any embrio-. Use of an erdostein during pregnancy and breastfeeding is possible only in case of need (because of the insufficient number of the clinical trials conducted on this group of patients) and if the advantage of the expected effect of treatment exceeds possible risk, especially in the first trimester of pregnancy. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect ability to run motor transport or other mechanisms. Overdose About cases of overdose of drug it was not reported, at overdose performing symptomatic therapy is recommended. A form of release and packing On 6 capsules in planimetric bezjyacheykovy packing from aluminum foil. On 2 or 5 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions in the place protected from light at a temperature not above 25ºС. To store out of children's reach. A period of storage 2 years not to apply after an expiration date Prescription status According to the prescription the Producer / Holder of the registration certificate of Macleods Pharmaceuticals Limited, India 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai – 400,059, India the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Branch KOO Macleods Pharmaceuticals Limited, Republic of Kazakhstan Almaty, Tulebayev St. 38/61, 5 the floor the Ph./fax. +7 727 2734593, 87012420565 E-mail:
To Develop regulatorykazakh@macleodspharma.com
To Develop regulatorykazakh@macleodspharma.com
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