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Hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestines and concentration in the bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids. It causes increased gastric and pancreatic secretion, enhances the activity of lipase.
It has a hypoglycemic effect.
It causes partial or complete dissolution of cholesterol stones when ingested, reduces the saturation of bile with cholesterol, which helps mobilize cholesterol from gallstones.
It has an immunomodulatory effect, affects the immunological reactions in the liver: reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, reduces the number of eosinophils.
- dissolution of cholesterol gall bladder stones;
- biliary reflux gastritis;
- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);
- chronic hepatitis of various genesis;
- primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis);
- non-alcoholic steatohepatitis;
- alcoholic liver disease;
- biliary dyskinesia.
1 caps - Ursodeoxycholic acid 250 mg.
Excipients: corn starch - 73 mg, colloidal silicon dioxide - 5 mg, magnesium stearate - 2 mg, titanium dioxide - 1.94 mg, gelatin - 80.51 mg, sodium lauryl sulfate - 0.2 mg, purified water - 14.55 mg.
Ursodeoxycholic acid is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Ursosan||PRO.MED.CS Praha a.s||Czech||capsules|
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Dosage and Administration
For dissolving cholesterol gallstones
The average daily dose is 250-500 mg (after or during meals), which is 1-2 capsules. The course of treatment is from 4-6 months to 12 months or more. The dose for maintenance therapy is 250 mg once a day.
With biliary reflux gastritis
250 mg once daily. The course of treatment is set by the doctor.
Symptomatic treatment of primary biliary cirrhosis
The daily dose depends on body weight and ranges from 2 to 6 capsules (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).
- Body weight 34-50 kg: 2 capsules (daily dose); in the morning - 1; in the afternoon - -; in the evening - 1.
- Body weight 51-65 kg: 3 capsules (daily dose); in the morning - 1; in the afternoon - 1; in the evening - 1.
- Body weight 66-85 kg: 4 capsules (daily dose); in the morning - 1; in the afternoon - 1; in the evening - 2.
- Body weight 86-110 kg: 5 capsules (daily dose); in the morning - 1; in the afternoon - 2; in the evening - 2.
- Body weight over 110 kg: 6 capsules (daily dose); in the morning - 2; in the afternoon - 2; in the evening - 2.
Backache; abdominal pain; diarrhea (can be dose-dependent); calcification of gallstones; transient (transient) increase in the activity of liver transaminases; alopecia; constipation; dizziness; nausea, vomiting; aggravation of previously existing psoriasis; allergic reactions, including urticaria.
- X-ray (high calcium) gallstones;
- nonfunctioning gallbladder;
- acute inflammatory diseases: gallbladder, bile ducts, intestines;
- cirrhosis of the liver in the stage of decompensation;
- marked impairment of function: kidney, liver, pancreas;
- pregnancy and lactation;
- hypersensitivity to the drug.
Concurrent use with drugs that reduce the intestinal absorption of bile acids (eg, colestiramine) and with drugs that increase biliary elimination of cholesterol (estrogens, hormonal contraceptives, some lipid-lowering drugs) is not recommended.
Concurrent use with potentially hepatotoxic drugs is not recommended.
Pregnancy and Lactation
Contraindicated in pregnancy and lactation.
When taking the drug in order to dissolve gallstones, the following conditions must be met: the stones must be cholesterol (X-ray negative), their size must not exceed 15x20 mm, the gallbladder must remain functional and must be filled with not more than half of the stones, the permeability of the cystic and common gall duct must be maintained.
With a long-term (more than 1 month) administration of the drug, every 4 weeks for the first 3 months of treatment, then every 3 months, a biochemical blood test is necessary to determine the activity of hepatic transaminases.
Monitoring the effectiveness of treatment should be carried out every 6 months according to the ultrasound of the biliary tract. After complete dissolution of the stones, it is recommended to continue the use of the drug for at least 3 months in order to facilitate the dissolution of the remains of stones, the dimensions of which are too small to be detected and to prevent the recurrence of stone formation.
In patients with frequent bouts of biliary colic, with infectious diseases, changes in the pancreas or intestinal lesions that can alter the intrahepatic circulation of bile acids (bowel resection or ileostomy, limited ileitis), it is advisable to avoid using the drug.
Symptoms: increased side effects.
Treatment: detoxification measures and the appointment of colestyramine (for the formation of chelate complexes with bile acids).
- Brand name: Ursofalk
- Active ingredient: Ursodeoxycholic acid
- Dosage form: Hard gelatin capsules, size No. 0, opaque, white; the contents of the capsules are white powder or granules.
- Manufacturer: Dr. Falk
- Jeune syndrome and liver disease: Report of three cases treated with ursodeoxycholic acid
- Autoimmune hemolysis associated with primary biliary cirrhosis responding to ursodeoxycholic acid as sole treatment
- Determination of the in vitro Dissolution Profiles of Ursodeoxycholic Acid Preparations by HPLC with On-Line Sample Handling
- A randomized clinical trial of oral ursodeoxycholic acid in obstructive jaundice
- The protective effect of ursodeoxycholic acid in alloxan-induced diabetes
- ChemInform Abstract: Basic Studies on the Utility of Ursodeoxycholic Acid Derivatives for Clinical Medicine
- A Combination of Chenodeoxycholic Acid and Ursodeoxycholic Acid is more Effective than Either Alone in Reducing Biliary Cholesterol Saturation
- Ursodeoxycholic acid vs. chenodeoxycholic acid as cholesterol gallstone-dissolving agents: A comparative randomized study
- Effect of Ursodeoxycholic Acid on Biliary Bile Acid and Bile Lipid Composition in Gallstone Patients
- Franco-Belgian Cooperative Study of Ursodeoxycholic Acid in the Medical Dissolution of Gallstones: A Double-Blind, Randomized, Dose-Response Study, and Comparison with Chenodeoxycholic Acid
- Effect of ursodeoxycholic acid on bile acid metabolism in primary biliary cirrhosis
- Hepatic expression of class I and class II major histocompatibility complex molecules in primary biliary cirrhosis: Effect of ursodeoxycholic acid
- Ursodeoxycholic acid in the treatment of primary biliary cirrhosis: First controlled data
- Ursodeoxycholic acid–induced changes of plasma and urinary bile acids in patients with primary biliary cirrhosis
- Effect of chronic administration of ursodeoxycholic acid on the ileal absorption of endogenous bile acids in man
- Distribution of cholesterol between vesicles and micelles in human gallbladder bile: Influence of treatment with chenodeoxycholic acid and ursodeoxycholic acid
- Effects of ursodeoxycholic acid on serum liver enzymes and bile acid metabolism in chronic active hepatitis: A dose-response study
- Failure of ursodeoxycholic acid to prevent a cholestatic episode in a patient with benign recurrent intrahepatic cholestasis: A study of bile acid metabolism
- Ursodeoxycholic acid and taurine as therapy for cholestatic liver disease
- Ursodeoxycholic acid for the treatment of primary sclerosing cholangitis: A 30-month pilot study
- Changes in bile acid composition in patients with primary biliary cirrhosis induced by ursodeoxycholic acid administration
- Efficacy and safety of ursodeoxycholic acid for dissolution of gallstone fragments: Comparison with the combination of ursodeoxycholic acid and chenodeoxycholic acid
- Effect of ursodeoxycholic acid on the kinetics of the major hydrophobic bile acids in health and in chronic cholestatic liver disease
- Scintigraphic documentation of an improvement in hepatobiliary excretory function after treatment with ursodeoxycholic acid in patients with cystic fibrosis and associated liver disease