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Ursozim 60s 250 mg capsule




The instruction for medical use of Ursozim® medicine the Trade name of Ursozim® the International unlicensed name Ursodezoksikholevaya acid the Dosage form of the Capsule, 250 mg Structure One capsule contains active agent – ursodezoksikholevy acid of 250 mg, excipients: potato starch, magnesium or calcium stearate, silicon dioxide colloidal anhydrous, structure of the capsule: gelatin, titan dioxide (E171), propylene glycol, methylparahydroxybenzoate, propilparagidroksibenzoat, sodium lauryl sulfate, acetic acid, silicon dioxide colloidal anhydrous. Description Solid gelatin capsules of white color. Contents of capsules – powder or granules of white or almost white color. 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 intake ursodezoksikholevy acid is quickly soaked up in a small intestine and at the beginning of an ileal gut by means of passive transport and in the termination of an ileal gut by means of active transport. Absorption speed, as a rule, is 60-80%. After absorption, bile acid is exposed to almost complete pairing in a liver with amino acids taurine and glycine, and then is removed with bile. The first clearance through a liver reaches 60%. Depending on a daily dose and the available disturbance or a condition of a liver, in bile more and more hydrophilic ursodezoksikholevy acid collects. At the same time, relative reduction of content of other, more lipophilic bile acids is observed. Under the influence of colibacilli there is a partial splitting of drug on 7-keto-lithocholic acid and lithocholic acid. Lithocholic acid of a gepatotoksichn can also cause parenchymatous damages of a liver at some animal species. At people very small amount which is sulphated in a liver is soaked up and thus it detoksitsirutsya before excretion with bile or, finally, with a stake. Biological elimination half-life of ursodezoksikholevy acid makes 3.5-5.8 days. The pharmacodynamics of Ursozim® – a gepatoprotektor has bile-expelling effect. Reduces synthesis of cholesterol in a liver, its absorption in intestines and concentration in bile, increases solubility of cholesterol in a bile-excreting system, stimulates education and removal of bile. Having high polar properties, UDHK 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 UDHK forms the double molecules capable to be included cellular membranes, to stabilize them and to do irresponsive to action of cytotoxic micelles. Reduces bile saturation cholesterol due to oppression of its absorption in intestines, suppression of synthesis in a liver and lowering of secretion in bile, increases solubility of cholesterol in bile, forming with them liquid crystals, reduces the litogenny index of bile. Dissolution of cholesteric gallstones and prevention of formation of new concrements is result. Immunomodulatory action is caused by oppression of an expression of HLA-of antigens on membranes of hepatocytes and holangiotsit, normalization of natural killerny lymphocyte activity, etc. Authentically delays progressing of fibrosis at patients with primary biliary cirrhosis, mucoviscidosis and an alcoholic steatogepatit, reduces risk of developing a varicosity of a gullet. Slows down processes of senilism and death of cells (hepatocytes, holangiotsit). Indications Adult – treatment of primary biliary cirrhosis (bedding set) and for dissolution of X-ray transparent gallstones at patients with the functioning gall bladder Children the Gepatobiliarny disturbances connected with cystous fibrosis at children from 6 to 18 years the Route of administration and doses Age restrictions for use of the Ursozim® capsules in a dosage of 250 mg for treatment of primary biliary cirrhosis and dissolution of gallstones are absent. For various indications the following daily modes of dosing are recommended: For treatment of primary biliary cirrhosis the Daily dose depends on body weight and varies from 3 to 7 capsules a day (14±2 mg of UDHK on body weight kg). Within the first 3 months of treatment, a daily dose UDHK should be accepted in stages. At improvement of indicators of a liver the daily dose can be accepted once in the evening. The body weight (kg) the Daily dose (mg/kg) of Урсозим® 250 mg of the capsule the First 3 months of treatment Subsequently morning put evening Evening (single dose) 47 – 62 12 – 16 1 1 1 3 63 – 78 13 – 16 1 1 2 4 79 – 93 13 – 16 1 2 2 5 94 – 109 14 – 16 2 2 2 6 Over 110 2 2 3 7 of the Capsule it is necessary to accept entirely, washing down with water. It is necessary to observe a reception interval carefully. Treatment of PBC it is possible to continue indefinite time. Dissolution of gallstones Adults the Usual daily dose makes 8-12 mg/kg a day, accepted daily in the evening, for example 750 mg. Time demanded for dissolution of gallstones is from 6 to 24 months depending on the sizes of stones and their structure. Control of efficiency of treatment is exercised by an ultrasonic method of a research or by means of X-ray analyses each 6 months. Treatment should be continued before obtaining positive takes of the 2nd holetsistogramm and/or the ultrasonography researches showing lack of stones with an interval in 4-12 weeks. Use of these methods is proved by restriction of opportunities of visualization of stones with a diameter less than 2 mm. Probability of a recurrence of stones after dissolution by bile acids is up to 50% within 5 years. Researches of efficiency of ursodezoksikholevy acid in treatment of X-ray contrast or partially rentgenokontrasty stones were not conducted, however it is possible to make the assumption that they are dissolved to a lesser extent, than X-ray transparent stones. Not cholesteric stones make 10-15% of X-ray transparent stones and can not be dissolved under the influence of bile acids. Elderly Dose adjustments as a rule it is not required from adults, however it is necessary to observe a certain care. Pediatric population Development of primary biliary cirrhosis and formation of the gallstones saturated with cholesterol in children is an unusual occurrence, and the dose should be selected according to body weight. Data on a profile of efficiency and safety at this category of patients are absent. The Gepatobiliarny disorders connected with cystous fibrosis Children Children with cystous fibrosis aged from 6 up to 18 years: 20 mg/kg a day accepted in 2-3 receptions with further increase to 30 mg/kg a day if necessary. The body weight (kg) the Daily dose (mg/kg) of Ursozim® of the capsule of 250 mg Morning Put Evening 20-29 17-25 1 – 1 30-39 19-25 1 1 1 40-49 20-25 1 1 2 50-59 21-25 1 2 2 60-69 22-25 2 2 2 70-79 22-25 2 2 3 80-89 22-25 2 3 3 90-99 23-25 3 3 3 100-109 23-25 3 3 4 ˃110 3 4 4 Side effects the Frequency of undesirable reactions is classified as follows: very frequent (≥1/10), frequent (≥1/100, & lt, 1/10), infrequent (≥1/1,000, & lt, 1/100), rare (≥1/10,000, & lt, 1/1,000), very rare (& lt, 1/10,000), it is unknown (it is impossible to estimate frequency on the basis of the available data). Gepatobiliarny disturbances: during treatment by ursodezoksikholevy acid calcification of gallstones in rare instances developed. It was seldom or never observed decompensations of hepatic cirrhosis which partially regressed after completion of therapy. From digestive tract: in clinical trials it was often reported about cases of a pastelike chair or diarrhea. Very seldom: severe pains in the right abdominal area at treatment of primary biliary cirrhosis. From integuments: seldom or never a small tortoiseshell developed. Contraindications of Урсозим® 250 mg of the capsule should not be applied if at the patient are present: – acute inflammatory diseases of a gall bladder or bile ducts – impassability of bile ducts (the general bile ducts or vesical channels) – frequent episodes of hepatic gripes – X-ray positive (with the high content of calcium) gallstones – disturbances of contractility of a gall bladder – hypersensitivity to components of drug or bile acids At use at the gepatobiliarny disturbances connected with cystous fibrosis for children are from 6 to 18 years: – an unsuccessful portoenterostomiya or without restoration of normal current of bile at children with a biliary atresia. Medicinal interactions Holestiramin, holestipol and the antacids containing aluminum hydroxide or smectite (aluminum oxide), reduce absorption of ursodezoksikholevy acid in intestines and thus reduce its absorption and efficiency. If use of the drugs containing at least one of these substances nevertheless is necessary, it is necessary to take them a minimum for 2 h to or after reception of Ursozima®. Ursodezoksikholevy acid can influence absorption of cyclosporine from intestines. Therefore at the patients accepting cyclosporine, the doctor has to check concentration of cyclosporine in blood and correct a cyclosporine dose in case of need. In clinical trial at healthy volunteers the simultaneous use of ursodezoksikholevy acid (500 mg/day) and rosuvastatin (20 mg/day) led to slightly increased level in rosuvastatin plasma. The clinical importance of this interaction together with other statines is unknown. In some cases Ursozim® can reduce ciprofloxacin absorption. It is proved that ursodezoksikholevy acid reduces peak plasma concentration (Cmax) and the area under a pharmacokinetic curve – a curve “concentration time” (AUC) of a nitrendipin, the antagonist of calcium at healthy volunteers. Careful monitoring of results of simultaneous use of a nitrendipin and ursodezoksikholevy acid is recommended. Increase in a dose of a nitrendipin can be necessary. Besides, it was reported about weakening of therapeutic effect of dapsone. On the basis of the provided data and also results of the researches in vitro, it is possible to assume that ursodezoksikholevy acid, induces enzymes 3A of P450 cytochrome, nevertheless, according to adequate clinical trial of medicinal interactions, ursodezoksikholevy acid does not cause the significant induction of a budesonid who belongs to substrates of P450 3A cytochrome. The estrogenic hormones and agents reducing cholesterol level in blood, such as Clofibratum increase hepatic secretion of cholesterol and, therefore, can stimulate formation of gallstones that is countereffect of the ursodezoksikholevy acid used for dissolution of stones in a gall bladder. Special indications of the Ursozim® Capsule should be accepted under medical control. Within the first three months of treatment it is necessary to control functional indicators of a liver of nuclear heating plant (SGOT), ALT (SGPT) and gamma GT each 4 weeks, and then each 3 months. Monitoring of the specified parameters allows to reveal abnormal liver functions at early stages, in particular – at patients at late stages of primary biliary cirrhosis, besides, thus it is possible to define quickly whether the patient with primary biliary cirrhosis reacts to the carried-out treatment. At treatment of an extensive stage of primary biliary cirrhosis it was Seldom or never observed decompensations of hepatic cirrhosis which partially regressed after completion of therapy. At patients with primary biliary cirrhosis in rare instances clinical symptoms I can worsen in an initiation of treatment, for example, the itching can develop. In this case the dose has to be reduced up to 250 mg a day with gradual increase to the recommended dose as it is described above. In case of development of diarrhea it is necessary to reduce a dosage, in case of long diarrhea – therapy should be cancelled. At use for dissolution of cholesteric gallstones: For assessment of progress in treatment and early detection of symptoms of calcification of stones depending on the size of stones, the gall bladder should be visualized (the oral cholecystography) with survey of blackouts in a standing position and lying on spin (ultrasonography) in 6-10 months after an initiation of treatment. If the gall bladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of a gall bladder or frequent attacks of gripes, the Урсозима® 250 capsules of mg should not be used. Women when using the Урсозима® 250 capsules of mg for dissolution of cholesteric gallstones have to use an effective non-hormonal method of contraception as hormonal contraceptives can increase formation of gallstones. At treatment of patients at late stages of primary biliary cirrhosis: Cirrhosis decompensation cases which partially regressed after the treatment termination were extremely seldom noted. At patients with primary biliary cirrhosis in rare instances clinical symptoms can worsen in an initiation of treatment, for example, the itching can increase. In such cases the dose of the Урсозима® 250 capsules of mg has to be reduced to one Урсозима® 250 capsule of mg a day, and then gradually again is increased. In case of diarrhea, the dose has to be reduced, in case of persistent diarrhea, treatment has to be stopped. Pregnancy and the period of a lactation Fertility of the Research on animals did not show influence of ursodezoksikholevy acid on fertility. Data on influence of ursodezoksikholevy acid on fertility at the person are absent. Pregnancy Data on use of ursodezoksikholevy acid for pregnant women are limited. Researches on animals showed reproductive toxicity at early stages of a gestation. Урсозим® it is not necessary to apply at pregnancy there will be no accurate need yet. Women of reproductive age of the Woman of reproductive age can receive therapy by ursodezoksikholevy acid only when using reliable methods of contraception: use of non-hormonal methods or contraceptives with the low content of estrogen is recommended. However, the patients receiving ursodezoksikholevy acid for dissolution of gallstones have to use non-hormonal contraceptives as hormonal oral contraceptives can increase risk of development of a biliary lithiasis. It is necessary to exclude pregnancy before therapy. Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Ursodezoksikholevaya acid has no negative impact on ability to driving and control of mechanisms. Overdose Symptoms: At overdose the diarrhea can develop. Other symptoms of overdose are improbable as absorption of ursodezoksikholevy acid decreases with increase in a dose and, therefore, is more allocated with a stake. Treatment: diarrheas symptomatic with completion of volume of liquid and electrolytic balance. Long-term treatment by high doses is (not for the intended purpose) connected by ursodezoksikholevy acid (28-30 mg/kg/day) at patients with primary sclerosing cholangitis with higher rates of serious side effects. A form of release and packing On 10 capsules in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 3, 5, 6 or 12 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard Storage conditions to Store in the dry, protected from light place at a temperature not over 250C. To store out of children’s reach! A period of storage 3 years not to use after expiry date Prescription status According to the prescription Republic of Kazakhstan Abdi Ibrahim Global Pharm LLP Producer, the Almaty Region, the Iliysky area, the Industrial zone 282 Owner of the Registration Certificate of Abdi Ibrahim Global Pharm LLP Republic of Kazakhstan Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, the Republic of Kazakhstan, the Almaty Region, the Iliysky area, the Industrial zone 282 Address of the Organization responsible for post-registration observation of safety of medicine in the territory of Republic
patches of light Kazakhstan Abdi Ibrahim Global Pharm LLP, the Republic of Kazakhstan, the Almaty Region, Iliysky area,
the Develop Industrial zone 282

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