Ursosan - instructions for use, reviews, analogs and formulations (capsules or tablets 250 mg) of the drug for the treatment of hepatitis, jaundice and other liver diseases in adults, children (including newborns) and pregnancy

In this article, you can read the instructions for using the drug Ursosan. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Ursosana in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Ursosan in the presence of existing structural analogs. Use for the treatment of hepatitis, jaundice, cirrhosis and other liver diseases in adults,children (including newborns), as well as during pregnancy and lactation.

Ursosan hepatoprotector. It also has choleretic, cholelitholitic, hypolipidemic, hypocholesterolemic and some immunomodulating action.

Possessing high polar properties, ursodeoxycholic acid forms nontoxic 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, ursodeoxycholic acid forms double molecules that can be included in the composition of cellular membranes of hepatocytes, cholangiocytes, GIT epitheliocytes, stabilize them and make them immune to the action of cytotoxic micelles.

Reducing the concentration of toxic bile acid for hepatocytes and stimulating choleresis, rich in bicarbonates, ursodeoxycholic acid effectively promotes 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.

Immunomodulating effect is caused by oppression of HLA-1 antigens expression on membranes of hepatocytes and HLA-2 on cholangiocytes, normalization of natural killer activity of lymphocytes, etc. Reliably delays 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. Ursodeoxycholic acid slows down the processes of premature aging and cell death (hepatocytes, cholangiocytes).

Composition

Ursodeoxycholic acid (ursodeoxycholic acid) + auxiliary substances.

Pharmacokinetics

Ursodeoxycholic acid is absorbed from the small intestine due to passive diffusion (about 90%), and in the ileum through active transport. Binding to plasma proteins is high - up to 96-99%. Penetrates through the placental barrier. With the systematic administration of Ursosan ursodeoxycholic acid becomes the main bile acid in the blood 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 ursodeoxycholic acid in bile. Metabolised in the liver (clearance during primary passage through the liver) into Taurine and Glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted with bile.

Indications

• uncomplicated cholelithiasis: biliary sludge; dissolution of cholesterol gallstones in the gallbladder, if they can not be removed by surgical or endoscopic methods; prevention of recurrence of stone formation after cholecystectomy;
• chronic active hepatitis;
• acute hepatitis;
• toxic (including medicinal) liver damage;
• alcoholic liver disease;
• non-alcoholic steatohepatitis;
• primary biliary cirrhosis;
• primary sclerosing cholangitis;
• cystic fibrosis (cystic fibrosis) of the liver;
• atresia of the intrahepatic biliary tract (including congenital atresia of the bile duct);
• biliary dyskinesia;
• biliary reflux gastritis and reflux esophagitis;
• biliary dyspeptic syndrome (with cholecystopathy and biliary dyskinesia);
• prevention of liver damage with the use of hormonal contraceptives and cytostatics.

Forms of release

Capsules 250 mg (forms in the form of tablets do not exist).

Instructions for use and dosing regimen

Capsules of Ursosana are taken orally by washing with a sufficient amount of water.

With diffuse liver disease, cholelithiasis (cholesterol gallstones and biliary sludge), the drug is prescribed continuously for a long time (from several months to several years) at a daily dose of 10 mg / kg body weight to 12-15 mg / kg (2- 5 capsules).

In case of diffuse liver diseases, the daily dose of Ursosana is divided into 2-3 doses, the capsules are taken with food.

With cholelithiasis, the whole daily intake is taken once for the night. The duration of taking the drug to dissolve the stones - until complete dissolution, and then another 3 months to prevent the recurrence of stone formation.

With biliary reflux gastritis and reflux esophagitis, the drug is prescribed 250 mg (1 capsule) per day, at bedtime. The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.

After cholecystectomy, for the prevention of recurrent cholelithiasis, the recommended dose is 250 mg twice a day for several months.

With toxic, medicinal liver damage, alcoholic liver disease and atresia of the biliary tract, the daily dose is set at the rate of 10-15 mg / kg per day in 2-3 doses.The duration of therapy is 6-12 months or more.

In primary biliary cirrhosis the drug is prescribed at the rate of 10-15 mg / kg per day (if necessary - up to 20 mg / kg) in 2-3 divided doses. The duration of therapy is from 6 months to several years.

With the primary sclerosing cholangitis - 12-15 mg / kg per day (up to 20 mg / kg) in 2-3 divided doses. The duration of therapy is from 6 months to several years.

With non-alcoholic steatohepatitis - 13-15 mg / kg per day in 2-3 divided doses. The duration of therapy is from 6 months to several years.

In cystic fibrosis, the dose is set at a rate of 20-30 mg / kg per day in 2-3 doses. The duration of therapy is from 6 months to several years.

For children over the age of 2 years, the dose of the drug is set individually at a rate of 10-20 mg / kg per day.

Side effect

• nausea, vomiting;
• diarrhea (can be dose-dependent);
• constipation;
• calcification of gallstones;
• backache;
• allergic reactions;
• exacerbation of previously existing psoriasis;
• alopecia.

Contraindications

• X-ray positive (high in calcium) gallstones;
• non-functioning gallbladder;
• bile-gastrointestinal fistula;
• acute cholecystitis;
• acute cholangitis;
• cirrhosis of the liver in the stage of decompensation;
• liver failure;
• kidney failure;
• obturation of bile ducts;
• acute infectious diseases of the gallbladder and bile ducts;
• empyema of the gallbladder;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

The use of ursodeoxycholic acid in pregnancy is possible only if the expected benefit for the mother exceeds the potential risk for the fetus (adequate strictly controlled studies of the use of ursodeoxycholic acid in pregnant women have not been performed).

Data on the isolation of ursodeoxycholic acid with breast milk are currently not available. If it is necessary to use ursodeoxycholic acid during lactation, the question of stopping breastfeeding should be solved.

special instructions

When applying the drug for the purpose of dissolution of gallstones, the following conditions must be observed: the stones must be cholesterol (X-ray negative), 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.

For a long (more than 1 month) drug intake every 4 weeks in the first 3 months of treatment, further - every 3 months, a biochemical blood test should be performed to determine the activity of hepatic transaminases. Control of the effectiveness of treatment should be carried out every 6 months according to ultrasound of bile ducts.

After complete dissolution of the stones, it is recommended that the use of Ursosan be continued for at least 3 months in order to promote the dissolution of stone remains that are too small to detect and prevent the recurrence of stone formation.

In experimental studies on animals, mutagenic and carcinogenic effects of ursodeoxycholic acid have not been revealed.

Drug Interactions

When combined, antacids containing aluminum and ion exchange resins (colestyramine) reduce the absorption of UDCA.

With simultaneous use, lipid-lowering drugs (especially clofibrate), estrogens, neomycin or progestins increase the saturation of bile with cholesterol and can reduce the ability of UDCA to dissolve cholesterol bile calculi.

Analogues of the drug Ursosan

Structural analogs for the active substance:

• Urdoks;
• Urso 100;
• Ursodez;
• Ursodeoxycholic acid;
• Ursodex;
• Ursuliv;
• Ursoron Rompharm;
• Ursor C;
• Ursofalk;
• Holudexan;
• Exxhol.

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