Ursor ромфарм

General characteristics. Structure:

Active agent: ursodezoksikholevy acid of 250 mg;
excipients: starch corn, povidone - KZO, silicon dioxide colloid, magnesium stearate;
structure of the capsule: titanium dioxide, dye blue patent, gelatin.

Description: capsules firm gelatinous No. 30, the case and a lid - smooth blestyayoshchy blue color. Contents of capsules - granules of white or almost white color.

Pharmacological properties:

Pharmacodynamics. Hepatoprotective means, renders also cholagogue, cholelitholytic, hypolipidemic, gipokholesterinemichesky and some immunomodulatory action.

Having high polar properties ursodezoksikholevy acid (UDHK) forms the non-toxic mixed micelles with non-polar (toxic) bile acids that reduces ability of a gastric reflyuktat to damage cellular membranes at biliary reflyuke-gastritis and a reflyuksezofagita. Besides, UDHK forms the double molecules capable to be included cellular membranes (hepatocytes, holangiotsit, epithelial cells of digestive tract (housing and public utilities)), to stabilize them and to do unreceptive to action of cytotoxic micelles. Reducing concentration of bile acids, toxic for a hepatic cell, and stimulating the cholepoiesis rich with UDHK bicarbonates effectively promotes permission of an intra hepatic cholestasia. Reduces a bile saturation cholesterol due to oppression of its absorption in intestines, suppression of synthesis in a liver and decreases in secretion in bile: increases solubility of cholesterol in bile, forming with it liquid crystals; whether-togenny reduces a bile index. Dissolution of cholesteric gallstones and the prevention of formation of new concrements is result. The immunopromoting effect is caused by oppression of an expression of HLA-1 antigens on membranes of hepatocytes and HLA-2 on holangiotsita, normalization of a natural killerny lymphocyte activity of PI other. Authentically progressing of fibrosis at patients with primary biliary cirrhosis, a mucoviscidosis and alcoholic steatogepatit detains; reduces risk of development of a varicosity of a gullet.

Pharmacokinetics. UDHK is absorbed in a small bowel due to passive diffusion (about 90%), and in an ileal gut by means of active transport. The maximum concentration in a blood plasma (Cmax) at intake of 500 mg in 30, 60, 90 min. - 3,8 mmol/l, 5,5 mmol/l and 3,7 mmol/l respectively. Stakh is reached in 1-3 h. Communication with proteins high - to 96-99%. Gets through a placental barrier. At systematic reception by Ursor the Romfarm of UDHK becomes the main bile acid in blood serum and makes about 48% of total quantity of bile acids in blood. The therapeutic effect of drug depends on concentration of UDHK in bile.

It is metabolized in a liver (clearance at primary passing through a liver) in tau-rinovy and glycine conjugates. The formed conjugates cosecrete in bile. About 50-70% of the general dose of drug are removed by bile. The insignificant quantity of not soaked up UDHK comes to a large intestine where is exposed to splitting by bacteria (7 dehydroxylation); the formed lithocholic acid partially is soaked up from a large intestine, but sulphated in a liver and quickly removed in the form of a sulfolitokholilglitsinovy or sulfolitokholiltaurinovy conjugate.

Indications to use:

Primary biliary cirrhosis in the absence of decompensation signs (symptomatic therapy), dissolution of small and average cholesteric stones at the functioning gall bladder, a biliary reflux gastritis.

Route of administration and doses:

URSOROM ROMFARM is accepted inside, washing down with enough water, For dissolution of cholesteric gallstones an average daily dose of-10 mg/kg that corresponds: for patients with the body weight from 34 to 60 kg - 2 capsules a day, respectively, 61-81 kg - 3 capsules, 81-100 kg - 4 capsules and over 100 kg - 5 capsules a day. Course of treatment of-6-12 months. For prevention of repeated formation of stones administration of drug within several more months after dissolution of stones rekomenkdutsya. At biliary a reflux gastritis the dose makes 250 mg once a day. A course of treatment - of 10-14 days to month, if necessary - up to 2 years.

Symptomatic therapy of primary biliary cirrhosis: an average daily dose of-10-15 mg/kg that corresponds: for patients with the body weight from 34 to 50 mg - 2 capsules a day, respectively, 51-65 kg - 3 capsules, 66-85 - 4 capsules, 86-110 kg - 5 capsules and over 110 kg - 6 capsules a day. Capsules accept in the evening, without chewing, washing down with a small amount of water.

Features of use:

At administration of drug for the purpose of dissolution of gallstones observance of the following conditions is necessary; stones have to be cholesteric (X-ray inactive), their size should not exceed 15-20 mm, the gall bladder has to remain functional and has to be filled with stones no more than on a half, passability of a vesical and general bilious channel has to be kept. At long (more than 1 month) administration of drug, each 4 weeks in the first 3 months of treatment, further - each 3 months to carry out biochemical analysis of blood for definition of activity of "hepatic" transaminases. Control of efficiency of treatment should be carried out kazhkdy months according to ultrasonic and X-ray inspection of biliary tract. After full dissolution of stones it is recommended to continue use of UROSOROM ROMFARM within, at least, 3 months, for this purpose, chtokba to promote dissolution of the remains of stones, the sizes которьж are too small for their detection and for prevention of a recurrence of a lithogenesis.

If within months after the beginning of therapy of partial dissolution of stones does not occur, it is improbable that treatment will be effective.

At appointment for the purpose of dissolution of gallstones control of activity of "hepatic" transaminases and alkaline phosphotazy, GGT, concentration of bilirubin is necessary. At preservation of the raised indicators drug should be cancelled. If the gall bladder cannot be visualized during a X-ray analysis, at an obyzkvestvleniya of gallstones, disturbance of sokratitelny ability of a gall bladder or frequent attacks of bilious colic treatment should be stopped.

Side effects:

Dorsodynia, nausea, vomiting, diarrhea (can be dozozavisimy), locks, passing (tranzitorny) increase in activity of "hepatic" transaminases, allergic reactions (including a small tortoiseshell), abdominal pain, it is rare - calcination bilious. stones, an exacerbation of earlier being available psoriasis, an alopecia.

Interaction with other medicines:

The antacids containing aluminum and ion-exchange resins (Colestyraminum) reduce drug absorption. Hypolipidemic medicines (especially Clofibratum), are oestrogenic, Neomycinum or progestogens increase bile saturation holesterikny and can reduce ability to dissolve cholesteric bilious concrements. Increases effect of peroral hypoglycemic drugs.

Contraindications:

Hypersensitivity to drug, rentgenpolozhitelny (with the high content of calcium) gallstones, a nonfunctioning gall bladder, bilious and gastric fistula, acute cholecystitis, an acute cholangitis, cirrhosis in decompensation stages, acute infectious diseases of a gall bladder, bilious channels and intestines, the expressed liver and/or renal failure, obturation of biliary tract, an empyema of a gall bladder, pregnancy, the lactation period, adults and children with body weight to 34 kg.

Overdose:

Cases of overdose of UDHK are not known.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. In the place, unavailable to children! A period of validity - 4 years. Not to use after the period of validity specified on packaging!

Issue conditions:

According to the recipe

Packaging:

Capsules of 250 mg. On 15 capsules in blisters from a film of polyvinyl chloride and aluminum foil. 2 blisters together with the application instruction place in a pack cardboard.