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Ursolisin 20s 150 mg capsule


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Brands:: MITIM (Italy)


The instruction for medical use of Ursolisin medicine the Trade name Ursolisin Mezhdunarodnoye the unlicensed name Ursodezoksikholevaya acid the Dosage form of the Capsule of 150 mg and 300 mg Structure One capsule contains active agent – ursodezoksikholevy acid of 150 mg or 300 mg, excipients: corn starch, magnesium stearate, silicon dioxide colloidal anhydrous, structure of a gelatin capsule: titan dioxide (E 171), gelatin. Description Solid gelatin capsules of white color. Contents of capsules – white powder. Pharmacotherapeutic group Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of biliary tract. Drugs of bile acids. Ursodezoksikholevy acid. The ATX A05AA02 code the Pharmacological Pharmacokinetics Later properties of oral administration ursodezoksikholevy acid is absorbed in digestive tract as by passive diffusion in lean and colonic guts, and at the expense of active transport in an ileal gut. Ursodezoksikholevy acid is metabolized mainly in a liver and removed in the conjugated form with bile by enterogepatichesky recirculation and partially – with excrements. A pharmacodynamics of Ursodezoksikholevaya acid is a bile acid which is physiologically produced in intestines of the person from cholic or chenodesoxycholic acids. Ursodezoksikholevy acid reduces cholesterol content in bile due to suppression of its synthesis and secretion by a liver and also inhibits intestinal absorption of cholesterol. The therapeutic effectiveness of drug is caused by its ability to normalize holepoetichesky function, to reduce a bile litogennost, to prevent formation of bilious concrements and to promote dissolution of already available cholesteric gallstones. Having the significant polar properties, ursodezoksikholevy acid forms the non-toxic mixed micelles with non-polar (toxic) bile acids that reduces ability of the gastric reflyuktat to damage cellular membranes at biliary a reflux gastritis and a reflux esophagitis. Besides ursodezoksikholevy acid forms the double molecules capable to be included cellular membranes, to stabilize them and to do irresponsive to action of cytotoxic micelles. Ursodezoksikholevy acid eliminates the dispeptic symptoms accompanying gepatobiliarny pathologies and is applied in cholestatic diseases of a liver. Experience of use of ursodezoksikholevy acid in treatment of children with the gepatobiliarny disturbances connected with a mucoviscidosis is available long-term, almost 10-year-old. There are data that use of ursodezoksikholevy acid can reduce proliferation in bile ducts, stop progressing of histologic changes and even contributes to involution of gepatobiliarny changes on condition of an initiation of treatment at early stages of a mucoviscidosis. For achievement of bigger efficiency the treatment using ursodezoksikholevy acid should be begun at once after diagnosis of a mucoviscidosis. Indications – for dissolution of the cholesteric X-ray negative stones of a gall bladder which are not exceeding 15 mm in the diameter at the functioning gall bladder – for treatment biliary a reflux gastritis – for treatment of primary biliary cirrhosis in the absence of signs of a decompensation as a part of complex therapy – for treatment of the gepatobiliarny disturbances connected with a mucoviscidosis at children from 6 to 18 years the Route of administration and doses For dissolution of cholesteric gallstones the Dose of drug select individually. Usually daily dose of drug makes 10 mg/kg of body weight. Capsules are recommended to be accepted once a day before going to bed, without chewing and washing down with a small amount of water. Treatment duration for dissolution of the available concrements is 6-24 months. If after 12 months of treatment of reduction of the sizes of gallstones it is not observed, then further continuation of therapy is inexpedient. Each 6 months it is necessary to control efficiency of therapy by means of ultrasonic or X-ray inspection. For prevention of a recurrence of cholelithiasis it is recommended to continue administration of drug for 3-4 months after dissolution of the available concrements. For treatment biliary a reflux gastritis the Dose of drug and duration of treatment are defined by the doctor for each patient individually. Usually appoint reception of 1 capsule in day in the evening before going to bed for 10-14 days. For symptomatic treatment of primary biliary cirrhosis the Daily dose of drug is selected the doctor individually depending on the body weight of the patient and usually makes 14 ± 2 mg of ursodezoksikholevy acid/kg of body weight. Capsules should be accepted, without chewing, washing down with a small amount of liquid. For the first 3 months of treatment it is recommended to divide a daily dose into 2-3 receptions. At improvement of indicators of hepatic function the dose of drug can be accepted one-time in the evening. Therapy can be carried out beyond all bounds long. The Gepatobiliarny disturbances connected with a mucoviscidosis For children with a mucoviscidosis aged from 6 up to 18 years a daily dose of 20 mg/kg divide into 2-3 receptions. Perhaps further increase in a dose up to 30 mg/kg/day if necessary. Side effects the Side reactions connected with use of ursodezoksilokhevy acid are listed below according to the frequency of their emergence: very often (≥ 1/10), it is frequent (from ≥ 1/100 to & lt, 1/10), infrequently (from ≥ 1/1000 to & lt, 1/100), is rare (from ≥ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000). Often – pastelike – diarrhea Very seldom – severe pains with localization in right hypochondrium during treatment of primary biliary cirrhosis – calcination of gallstones – the cirrhosis decompensation at treatment of primary biliary cirrhosis at late stages of a disease which is partially regressing after drug withdrawal – a small tortoiseshell of the Contraindication – hypersensitivity to active agent, bile acids or auxiliary components of drug – the X-ray positive (calcinated) gallstones – impassability of bile ducts (general bilious or vesical channels) – frequent episodes of hepatic gripes – disturbances of contractility of a gall bladder – acute inflammatory diseases of a gall bladder, biliary tract or intestines, including an empyema of a gall bladder – unsuccessful results of a portoenterostomiya or lack of adequate bilious outflow at children with an atresia of bile ducts Medicinal interactions Ursolisin it is not necessary to appoint mortars along with holestiraminy, kolestipoly or the antiacid drugs containing hydroxide or aluminum oxide (smectite) as these drugs in intestines connect ursodezoksikholevy acid and, thus, inhibit its absorption and reduce efficiency of therapy. If necessary these drugs need to be taken, at least, with a 2-hour interval to or after Ursolisin’s reception. Ursodezoksikholevy acid can increase absorption of cyclosporine from intestines. Therefore when performing such combination therapy it is necessary to control the serumal level of cyclosporine and if necessary to regulate its dose. In some cases ursodezoksikholevy acid can reduce ciprofloxacin absorption. In clinical trial the concomitant use of ursodezoksikholevy acid (500 mg/day) and rosuvastatin (20 mg/day) led to some increase in levels of rosuvastatin in blood plasma of healthy volunteers. The clinical value of this interaction and similar interactions with other statines is unknown. It was shown that at healthy volunteers ursodezoksikholevy acid reduces values of the maximum concentration in blood plasma (Cmax) and values of the area under curve (AUC) of a nitrendipin − the antagonist of calcium. It is recommended to control carefully consequences of simultaneous use of a nitrendipin and ursodezoksikholevy acid. In such cases the increase in a dose of a nitrendipin can be required. Also there is information on interaction of ursodezoksikholevy acid and dapsone which leads to decrease in its therapeutic effectiveness. These data indicate possible induction by ursodezoksikholevy acid of isoenzymes of P450 3A cytochrome though it was not confirmed in controlled clinical trials. Estrogen and some hypolipidemic drugs, such as Clofibratum, can promote formation of bilious concrements and, thus, reduce efficiency of ursodezoksikholevy acid at dissolution of gallstones. Special instructions for the first 3 months of treatment every 4 week it is necessary to control functional parameters of a liver and to determine levels of aspartate aminotransferase (nuclear heating plant), alaninaminotranspherase (ALT) and gamma glutamiltransferazy (GGT), further such tests are recommended to be carried out every 3 month. Such monitoring allows to establish the patients with primary biliary cirrhosis responding to performing therapy and also to carry out early identification of possible deterioration in hepatic function, especially patients with primary biliary cirrhosis at late stages have diseases. For assessment of therapeutic effect and early detection of possible calcination of concrements in 6-10 months after an initiation of treatment, depending on the size of stones, it is necessary to conduct a research of a general view of a gall bladder (oral cholecystography) and diagnostics of possible occlusion of bile ducts in a standing position and lying on spin (ultrasonography). Ursolisin it is not necessary to appoint at impossibility of receiving a holetsistogramma of a gall bladder, in the presence of the calcinated stones, at disturbances of contractility of a gall bladder or frequent hepatic gripes. The patients accepting Ursolisin for dissolution of cholesteric gallstones have to use effective non-hormonal methods of contraception as hormonal contraceptives can promote formation of bilious concrements. At use of ursodezoksikholevy acid for treatment of primary biliary cirrhosis at late stages of a disease cirrhosis decompensation cases which partially regressed after drug withdrawal were very seldom observed. In rare instances at patients with primary biliary cirrhosis in an initiation of treatment disease symptoms can worsen, for example, to amplify an itching. In such cases it is necessary to reduce a dose of ursodezoksikholevy acid to one capsule a day and then gradually to increase a daily dose of drug before achievement of the appointed dose. In case of development of diarrhea it is necessary to reduce a drug dose, and in case of persistent diarrhea the treatment should be stopped. Pregnancy and a lactation of Sufficient data on use of ursodezoksikholevy acid during pregnancy it is not received. Researches on animals demonstrate existence of teratogenic action during an initial stage of pregnancy. Prior to drug treatment it is necessary to exclude pregnancy. Women of reproductive age can appoint drug only at the condition of application of reliable means of contraception – use of the non-hormonal or containing low doses estrogen of contraceptives is recommended. However, at dissolution of gallstones the patients should use effective non-hormonal methods of contraception as oral hormonal contraceptives can promote formation of concrements. According to several documented cases, very insignificant amounts of ursodezoksikholevy acid get to breast milk of the women nursing therefore at the babies who are on breastfeeding, emergence of side reactions is not expected. Data on influence of ursodezoksikholevy acid on fertility of the person are absent. Children Basic age restrictions for use of drugs of ursodezoksikholevy acid are absent. But children with body weight is less than 47 have some and/or the patients experiencing difficulties with swallowing of capsules are recommended to use drugs of ursodezoksikholevy acid in other dosage form (for example, suspension for intake). The feature of influence on ability to run the vehicle or potentially dangerous mechanisms does not influence. Overdose in case of overdose of drug the development of diarrhea is possible. In general, development of other symptoms of overdose is improbable since at increase in the accepted dose the absorption of ursodezoksikholevy acid decreases and increases its removal with excrements. At overdose performing specific therapy is not required, consequences of diarrhea it is necessary to treat symptomatic by means of rehydration and substitution of electrolytes. Additional information on separate groups of patients Long therapy by high doses of ursodezoksikholevy acid (28-30 mg/kg/day) of patients with primary sclerosing cholangitis (use according to the unregistered indication) was connected with higher frequency of serious side reactions. A form of release and packing On 10 capsules in blister strip packaging from a film of PVC and aluminum foil. On 2 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 25 ºC. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Mitim of Neuter of l. / Mitim S.r.l. Via Kachchamali, 34-36-38 – 25125 Brescia, Italy (Via Cacciamali, 34-36-38 – 25125 Brescia, Italy) the Owner of the registration certificate Magis Pharmasyyutichi of Neuter of l., Brescia, Italy (Magis Farmaceutici S.r.l., Brescia, Italy) the Name, the address and a contact information 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: “Nova East Pharm Kazakhstan (Nova East Pharmaceutical Kazakhstan)” Republic of Kazakhstan, 050000, Almaty, Panfilov St. 98, office 507
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