Ursodeoxycholic acid capsules Vertex 250mg, No. 100

Primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

dissolution of cholesterol stones of the gallbladder;

biliary reflux gastritis;

primary sclerosing cholangitis;

alcoholic liver disease;

non-alcoholic steatohepatitis;

cystic fibrosis (cystic fibrosis);

chronic hepatitis of various origins;

biliary dyskinesia.

Inside, without chewing, with a little water.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 caps. - approximately (14 ± 2) mg of UDCA per 1 kg. In the first 3 months of treatment, the dose of the drug should be divided into several doses throughout the day. After improvement of hepatic parameters, the daily dose of the drug can be taken 1 time, in the evening.

The following mode of application is recommended

The drug should be taken regularly. The duration of therapy is unlimited.

Dissolution of cholesterol gallbladder stones

The recommended dose is 10 mg of UDCA per 1 kg / day.

The drug must be taken daily in the evening, before bedtime. The duration of therapy is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.

Treatment of biliary reflux gastritis

1 caps. the drug daily 1 time per day before bedtime. The course of treatment is from 10-14 days to 6 months, if necessary, up to 2 years.

Primary sclerosing cholangitis

The daily dose is 12-15 mg / kg; if necessary, the dose can be increased to 20-30 mg / kg in 2-3 divided doses. The duration of therapy is from 6 months to several years.

Alcoholic liver disease

The average daily dose is 10-15 mg / kg in 2-3 divided doses. The duration of therapy is 6-12 months or more.

Non-alcoholic steatohepatitis

The average daily dose is 10-15 mg / kg in 2-3 divided doses. The duration of therapy is 6-12 months or more.

Cystic fibrosis (cystic fibrosis)

The daily dose is 12-15 mg / kg; if necessary, the dose can be increased to 20-30 mg / kg in 2-3 divided doses. The duration of therapy ranges from 6 months to several years or lifelong.

Chronic hepatitis of various origins

The daily dose is 10-15 mg / kg in 2-3 divided doses. The duration of therapy is 6-12 months or more.

Biliary dyskinesia

The average daily dose is 10 mg / kg in 2 divided doses. The duration of therapy is from 2 weeks to 2 months. If necessary, the course of treatment is recommended to be repeated.

For children over 3 years of age, the drug is prescribed individually, at the rate of 10Ц20 mg / kg / day.

Active substance: ursodeoxycholic acid - 250 mg

Excipients: corn starch - 73 mg; colloidal anhydrous silicon dioxide - 5 mg; magnesium stearate - 2 mg hard gelatin capsule: gelatin - 98%; titanium dioxide (E171) - 2%

Hypersensitivity to the components of the drug;

X-ray positive (high calcium) gallstones;

non-functioning gallbladder;

acute inflammatory diseases of the gallbladder, bile ducts and intestines;

cirrhosis of the liver in the stage of decompensation;

severe impaired renal function, liver, pancreas.

UDCA has no age restrictions for use, however, children under 3 years of age are not recommended to use the drug in this dosage form.

With caution: in children from 3 to 4 years old, because it may be difficult to swallow the capsules.

pharmachologic effect

Hepatoprotective agent, has a choleretic, cholelitholytic, hypocholesterolemic, hypolipidemic, immunomodulatory effect.

It is incorporated into the membrane of the hepatocyte, stabilizes its structure and protects the hepatocyte from the damaging effect of bile salts, thus reducing their cytotoxic effect. In cholestasis, it activates Ca2 + -dependent alpha-protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic and others), the concentrations of which are increased in patients with chronic liver diseases.

Competitively reduces the absorption of lipophilic bile acids in the intestine, increases their 'fractional' turnover during enterohepatic circulation, induces choleresis, stimulates the passage of bile and the excretion of toxic bile acids through the intestine.

Shields non-polar bile acids (chenodeoxycholic), due to which mixed (non-toxic) micelles are formed.

Reduces the saturation of bile with cholesterol by reducing the synthesis and secretion of cholesterol in the liver and inhibiting its absorption in the intestine.

Increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases the concentration of bile acids in it, causes an increase in gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect.

It causes partial or complete dissolution of cholesterol gallstones, reduces the saturation of bile with cholesterol, which contributes to its mobilization from gallstones.

It has an immunomodulatory effect, affects immunological reactions in the liver: reduces the expression of some histocompatibility antigens - HLA-1 on the membrane of hepatocytes and HLA-2 on cholangiocytes, affects the number of T-lymphocytes, the formation of interleukin 2, reduces the number of eosinophils, suppresses immunocompetent Ig (in primarily IgM).

Indications of the drug

• primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

• dissolution of cholesterol stones of the gallbladder;

• biliary reflux gastritis;

• primary sclerosing cholangitis;

• alcoholic liver disease;

• non-alcoholic steatohepatitis;

• cystic fibrosis (cystic fibrosis);

• chronic hepatitis of various origins;

• biliary dyskinesia.

Dosage regimen

The capsules are taken orally, without chewing, with a little water.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight). In the first 3 months of treatment, taking the drug UrdoksaЃ should be divided into several doses during the day. After improvement of hepatic parameters, the daily dose of the drug can be taken 1 time, in the evening.

Contraindications for use

• X-ray positive (high calcium) gallstones;

• non-functioning gallbladder;

• acute inflammatory diseases of the gallbladder, bile ducts and intestines;

• cirrhosis of the liver in the stage of decompensation;

• severe violations of the kidneys, liver, pancreas;

• hypersensitivity to the components of the drug.

• Ursodeoxycholic acid has no age restrictions for use, however, children under 3 years of age are not recommended to use the drug in this dosage form.

Use with caution in children aged 3 to 4 years, because it may be difficult to swallow the capsules.

Application during pregnancy and lactation

In experimental studies on animals, no mutagenic and carcinogenic effects of ursodeoxycholic acid were detected. The use of the drug during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus (adequate, strictly controlled studies of the use of ursodeoxycholic acid in pregnant women have not been conducted).

If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved. There are currently no data on the excretion of ursodeoxycholic acid in breast milk.

Application for violations of liver function

Contraindication: severe liver dysfunction, liver cirrhosis in the stage of decompensation.

Application for impaired renal function

Contraindication: severe renal dysfunction.

Application in children

Ursodeoxycholic acid has no age restrictions for use, however, children under 3 years of age are not recommended to use the drug in this dosage form.

Use with caution in children aged 3 to 4 years, because it may be difficult to swallow the capsules.

For children over 3 years old, ursodeoxycholic acid is prescribed individually at the rate of 10-20 mg / kg / day.

special instructions

The drug should be taken under medical supervision.

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 15-20 mm, the gallbladder must remain functional and must be filled with stones no more than half, the patency of the cystic and the common bile duct must be preserved. With long-term (more than 1 month) taking the drug every 4 weeks in the first 3 months of treatment, then every 3 months, it is necessary to carry out a biochemical blood test to determine the activity of hepatic transaminases. Monitoring the effectiveness of treatment should be carried out every 6 months according to ultrasound of the biliary tract. After complete dissolution of the stones, it is recommended to continue using the drug for at least 3 months in order toto help dissolve the remains of stones, the size of which is too small to detect them and to prevent recurrence of stone formation.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking 1 capsule daily, then the dose should be increased (increasing the daily dose by 1 capsule weekly) until the recommended dosage regimen is reached again.

In case of development of undesirable or severe reactions, the patient should immediately inform the attending physician about them and, in no case, should not continue taking the drug without his recommendation.

Influence on the ability to drive vehicles and use mechanisms

No influence on the ability to drive vehicles and work with mechanisms was identified.

Overdose

Cases of overdose of ursodeoxycholic acid are unknown. In case of overdose, symptomatic treatment is recommended.

Drug interactions

Cholestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is necessary, they should be taken at least 2 hours before taking UrdoksaЃ.

Ursodeoxycholic acid can enhance intestinal absorption of cyclosporine. Therefore, in patients taking cyclosporine, the concentration of cyclosporine in the blood should be checked and the dose of cyclosporine adjusted if necessary.

In some cases, it can reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or gestagens increase the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol gallstones.

The patient should inform the doctor about all medications he is taking.