Ursor C - instructions for use, dose, side effects, contraindications

Description:Capsules hard gelatinous № 0, the case and a lid - smooth shining blue colors. The contents of capsules are granules of white or almost white color.

Pharmacotherapeutic group:Hepatoprotective agent

ATX: & nbsp

A.05.A.A Preparations of bile acids

Pharmacodynamics:

Hepatoprotective agent, also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and some immunomodulating action.

Possessing high polar properties ursodeoxycholic acid (UDCA) forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes with biliary reflux gastritis and reflux esophagitis.In addition, UDCA forms double molecules that can be included in the composition of cell membranes (hepatocytes, cholangiocytes, gastrointestinal tract epitheliocytes (HCW)), stabilize them and render them immune to the action of cytotoxic micelles. Reducing the concentration of toxic to the hepatic cell bile acids and stimulating choleresis, bicarbonate-rich UDCA effectively contributes to the resolution of intrahepatic cholestasis. Reduces the saturation of bile with cholesterol due to inhibition of its absorption in the intestine, suppression of synthesis in the liver and a decrease in secretion in bile; increases the solubility of cholesterol in bile, forming with it liquid crystals; reduces the lithogenic bile index. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new concrements. Immunostimulating effect due to inhibition of expression of antigens HLA-1 on membranes of hepatocytes and HLA-2 on cholangiocytes, normalization of the natural killer activity of lymphocytes, etc. Reliably delay the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis; reduces the risk of developing varicose veins of the esophagus.

Pharmacokinetics:

UDCA is absorbed in the small intestine due to passive diffusion (about 90%), and in the ileum through active transport. Maximum concentration in blood plasma (FROM_m_Oh) when administered 500 mg after 30, 60, 90 minutes - 3.8 mmol / l, 5.5 mmol / l and 3.7 mmol / l, respectively. FROM_m_Oh is achieved in 1-3 hours. The connection with proteins is high - up to 96-99%. Penetrates through the placental barrier. With the systematic intake of Ursor Rhompharm UDCA becomes the main bile acid in the serum and accounts for about 48% of the total amount of bile acids in the blood. The therapeutic effect of the drug depends on the concentration of UDCA in the bile.

Metabolised in the liver (clearance during primary passage through the liver) into taurine and glycine conjugates. The resulting conjugates are secreted in bile. About 50-70% of the total dose of the drug is excreted by bile. A small amount of unsweetened UDCA enters the large intestine, where it undergoes cleavage by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon but is sulfated in the liver and is rapidly excreted as a sulfolithocholylglycine or sulfolithocholyltaurine conjugate.

Indications:

- the dissolution of small and medium-sized stones with cholesterol functioning gallbladder, prevention of recurrence of stone formation after cholecystectomy;

- chronic hepatitis of various genesis;

- cholestatic liver diseases of various origins, including primary biliary cirrhosis, with no signs of decompensation (symptomatic therapy), primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis);

- primary non-alcoholic steatohepatitis

- alcoholic liver disease;

- biliary dyskinesia;

- Biliary reflux-gastritis and reflux-esophagitis.

Contraindications:

Hypersensitivity to the drug, rentgenpolozhitelnye (high calcium) gallstones, nonfunctioning gallbladder, bile, gastric fistula, acute cholecystitis, acute cholangitis, cirrhosis of the liver decompensation, acute infectious disease gallbladder, bile ducts and intestine, severe liver and / or renal failure, obturation biliary tract, empyema of the gall bladder, pregnancy, lactation, adults and children weighing up to 34 kg.

Dosing and Administration:

Inside.Capsule swallowed whole, without chewing, squeezed a small amount of water. The drug must be taken regularly.

To dissolve cholesteric gallstones the average daily dose of the drug is 10 mg / kg per day, it is recommended to take the entire daily dose of the drug once a night before bedtime. The course of treatment is 6-12 months.

For the prevention of repeated formation of stones, it is recommended to take the drug for several months after the dissolution of the stones.

After cholecystectomy for prevention of recurrent cholelithiasis - 250 mg twice a day for several months.

When chronic hepatitis of various genesis (toxic, medicinal, etc.), primary nonalcoholic steatohepatitis, alcoholic liver disease the average daily dose is 10-15 mg / kg body weight in 2-3 doses. The duration of therapy is 6-12 months or more.

When cholestatic liver diseases various genesis, including: primary biliary cirrhosis, primary sclerosing cholangitis a drug appoint a daily dose of 10-15 mg / kg; if necessary, the average daily dose can be increased to 20-30 mg / kg in 2-3 doses.The duration of therapy is from 6 months to several years.

When cystic fibrosis (cystic fibrosis) usually prescribed in a daily dose of 20-30 mg / kg body weight. The course of treatment is up to 6 months, if necessary - up to 2 years.

When dyskinesia of the bile duct According to the hypokinetic type, the average daily dose is 10 mg / kg in 2 divided doses for 2 weeks to 2 months. If necessary, treatment is recommended repeat.

When Biliary reflux gastritis and reflux esophagitis - 250 mg once a day, before bedtime. The course of treatment is from 10-14 days.

Calculation of the daily number of capsules depending on the patient's body weight and the recommended dose of the drug per 1 kg of body weight

Weight	10	15	20	30
body, kg	mg / kg / day	mg / kg / day	mg / kg / day	mg / kg / day
34-50	2 caps	3 caps	4 caps	5 caps
51-65	3 caps	4 caps	5 caps	6 caps
66-85	4 caps	5 caps	6 caps	7 caps
86-110	5 caps	6 caps	7 caps	8 caps
> 110	6 caps	7 caps	8 caps	9 caps

Side effects:

Back pain, nausea, vomiting, diarrhea (may be dose-dependent), constipation, transitory (transient) increase in activity of "liver" transaminases, allergic reactions (including urticaria), abdominal pain, rarely calcification of gallstones, exacerbation of previously existing psoriasis , alopecia.

Overdose:

Cases of overdose UDCA are not known.

Interaction:

Antacids containing aluminum and ion-exchange resins (colestramine), reduce the absorption of the drug. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin or progestogens increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol bile stones. Increases the effect of oral hypoglycemic drugs.

Special instructions:

When taking the drug for the purpose of dissolution of gallstones, it is necessary to observe the following conditions: the stones should be cholesterol (roentgen-active), their size should not exceed 15-20 mm, the gallbladder should remain functional and should be filled with stones no more than half, the permeability of the cystic and of the common bile duct should be preserved. With prolonged (more than 1 month) drug intake, every 4 weeks in the first 3 months of treatment, then - every 3 months to conduct a biochemical blood test to determine the activity of "liver" transaminases. Control of the effectiveness of treatment should be carried out every 6 months according to ultrasound and radiographic examination of the biliary tract.After complete dissolution of the stones, it is recommended to continue the use of UROSOROM ROMFARM for at least 3 months, in order to facilitate the dissolution of stone remains, the sizes of which are too small for their detection and for the prevention of recurrence of stone formation.

If within 6 months after the initiation of therapy, partial dissolution of the stones did not occur, it is unlikely that the treatment will be effective.

At the appointment with the purpose of dissolution of gallstones, it is necessary to control the activity of "liver" transaminases and alkaline phosphatase, GGT, bilirubin concentration. If the increased indices remain, the drug should be discontinued.

If the gallbladder can not be visualized during radiography, with calcification of gallstones, impaired contractility of the gallbladder, or frequent attacks of biliary colic, treatment should be discontinued.

Form release / dosage:

Capsules 250 mg.

Packaging:

10 capsules in a contour cell box made of polyvinylchloride film and aluminum foil.

By 1, 2, 3, 5 or 10 contour mesh packages together with instructions for use in a pack of cardboard. For 15 capsules in a planar cell packaging from a polyvinylchloride film and aluminum foil. 2 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Inaccessible to children!

Shelf life:

4 years. Do not use after the expiration date stated on the package!

Terms of leave from pharmacies:On prescription

Registration number:LSR-003648/10

Date of registration:30.04.2010 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Information update date: & nbsp13.07.2016

Illustrated instructions

Instructions

Ursorо® С (Ursorom C)