Ursodez, 500 mg capsules 10 pcs.

Hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and its concentration in the bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile.

Decreases the lithogenicity of bile, increases the content of bile acids in it. Causes increased gastric and pancreatic secretion and increases lipase activity. It has a hypoglycemic effect.

It causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has immunomodulatory effects, influences immunological reactions in the liver: it reduces the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, interleukin-2 formation, reduces the number of eosinophils.

Indications

— dissolution of small and medium-sized cholesterol stones with a functioning gallbladder;

– biliary reflux gastritis;

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

— chronic hepatitis of various origins;

– primary sclerosing cholangitis;

– cystic fibrosis (cystic fibrosis);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Pharmacological effect

Hepatoprotector. Has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestines and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile.

Reduces the lithogenicity of bile and increases the content of bile acids. Causes increased gastric and pancreatic secretion, enhances lipase activity. Has a hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.

Special instructions

The use of Ursodez should be carried out under the supervision of a physician.

During the first 3 months of treatment, liver function parameters (transaminases, alkaline phosphatase and GGT) in the blood serum should be monitored every 4 weeks, and then every 3 months. Monitoring these parameters makes it possible to identify liver dysfunction in the early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, it can quickly determine whether a patient with primary biliary cirrhosis is responding to treatment.

Used to dissolve cholesterol gallstones

In order to assess progress in treatment, as well as to promptly detect signs of calcification of stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine position (ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on x-rays or in cases of calcified stones, poor gallbladder contractility, or frequent bouts of colic, Ursodez should not be used.

Treatment of patients in advanced stages of primary biliary cirrhosis

Cases of decompensation of liver cirrhosis have been reported extremely rarely. After cessation of therapy, regression of decompensation manifestations was noted.

Long-term therapy with ursodeoxycholic acid in high doses (28-30 mg/kg/day) can lead to the development of serious side effects in patients with primary sclerosing cholangitis.

In patients with diarrhea, the dose of the drug should be reduced. If diarrhea persists, treatment should be discontinued.

Impact on the ability to drive vehicles and operate machinery

There was no effect on the ability to drive vehicles and machinery.

Active ingredient

Ursodeoxycholic acid

Composition

1 caps. – ursodeoxycholic acid 500 mg.

Pregnancy

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Contraindications

– X-ray positive (high calcium content) gallstones;

– non-functioning gallbladder;

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

— liver cirrhosis in the stage of decompensation;

– severe renal dysfunction;

– severe liver dysfunction;

– severe dysfunction of the pancreas;

– adults and children weighing up to 34 kg;

– children under 3 years of age (for this dosage form);

– hypersensitivity to the components of the drug.

The drug should be prescribed with caution for cholelithiasis and cholestatic liver diseases.

Side Effects

From the digestive system: diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of liver transaminases.

When treating primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Other: allergic reactions.

Interaction

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 Ursodez.
Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, cyclosporine blood concentrations should be checked and the dose of cyclosporine adjusted if necessary.

In some cases, Ursodez may 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.

Overdose

No cases of overdose have been identified. In case of overdose, symptomatic treatment is carried out.

Recommendations for use

The drug is taken orally.

Dissolution of cholesterol gallstones

The recommended (approximate) dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day. The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid.

It usually takes 6-24 months for gallstones to dissolve. If after 12 months of treatment the size of the stones does not decrease, then treatment should be stopped.

The effectiveness of treatment should be assessed every 6 months with ultrasound or radiography. During the interim examination, it is necessary to assess whether calcification of the stones has occurred during the intervening period. In case of calcification of stones, treatment should be discontinued.

To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.

Treatment of biliary reflux gastritis

Recommended dose – 1 capsule. (250 mg) of Ursodez® daily in the evening before bed. Capsules should be taken with a small amount of water.

The course of treatment is from 10-14 days to 6 months, if necessary – up to 2 years.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 1 to 3 caps. (500 mg) or from 2 to 6 caps. (250 mg) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight) in 2-3 doses, the first 3 months of treatment. After improving the functional parameters of the liver, the daily dose can be used 1 time in the evening. The duration of treatment is not limited. In rare cases, at the beginning of treatment, clinical symptoms may worsen (itching may become more frequent). In this case, the daily dose should be reduced (to 250 mg), and then gradually increased (increasing the daily dose weekly) until the recommended dosage regimen is achieved.

Chronic hepatitis of various origins, non-alcoholic steatohepatitis and alcoholic liver disease

The average daily dose is from 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight in 2-3 doses. The duration of therapy is 6-12 months or more.

Primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)

For primary sclerosing cholangitis: 12-15 mg/kg/day (up to 20 mg/kg/day) in 2-3 doses. Duration of use – from 6 months to several years.

For cystic fibrosis (cystic fibrosis): 20-30 mg/kg/day in 2-3 doses. Duration of use – from 6 months to several years.

Biliary dyskinesia

The average daily dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight in 2 divided doses for 2 weeks to 2 months. If necessary, the course of treatment must be repeated. The dosage regimen is determined by the doctor.

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

Body weight, kg
10 mg/kg/day
12 mg/kg/day
15 mg/kg/day
20 mg/kg/day
30 mg/kg/day
34-35
1 caps. 250 mg
2 caps. 250 mg or 1 capsule. 500 mg each
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
36-40
2 caps. 250 mg or 1 capsule. 500 mg each
2 caps. 250 mg or 1 capsule. 500 mg each
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
5 caps. 250 mg each
41-45
2 caps. 250 mg or 1 capsule. 500 mg each
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
4 caps. 250 mg or
2 caps. 500 mg each
5 caps. 250 mg each
45-50
2 caps. 250 mg or 1 capsule. 500 mg each
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
4 caps. 250 mg or
2 caps. 500 mg each
6 caps. 250 mg or 3 caps. 500 mg each
51-55
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
3 caps. 250 mg each
4 caps. 250 mg or
2 caps. 500 mg each
7 caps. 250 mg each
56-60
2 caps. 250 mg or 1 capsule. 500 mg each
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
7 caps. 250 mg each
61-65
3 caps. 250 mg each
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
8 caps. 250 mg or 4 caps. 500 mg each
66-70
3 caps. 250 mg each
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
6 caps. 250 mg or 3 caps. 500 mg each
8 caps. 250 mg or 4 caps. 500 mg each
71-75
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
6 caps. 250 mg or 3 caps. 500 mg each
9 caps. 250 mg each
76-80
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
6 caps. 250 mg or 3 caps. 500 mg each
10 caps. 250 mg or 5 caps. 500 mg each
81-85
3 caps. 250 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
7 caps. 250 mg each
10 caps. 250 mg or 5 caps. 500 mg each
86-90
4 caps. 250 mg or 2 caps. 500 mg each
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
7 caps. 250 mg each
11 caps. 250 mg each
91-95
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
6 caps. 250 mg or 3 caps. 500 mg each
8 caps. 250 mg or 4 caps. 500 mg each
11 caps. 250 mg each
96-100
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
6 caps. 250 mg or 3 caps. 500 mg each
8 caps. 250 mg or 4 caps. 500 mg each
12 caps. 250 mg or 5 caps. 500 mg each
101-105
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
6 caps. 250 mg or 3 caps. 500 mg each
8 capm. 250 mg or 4 caps. 500 mg each
13 caps. 250 mg each
105-110
4 caps. 250 mg or 2 caps. 500 mg each
5 caps. 250 mg each
7 caps. 250 mg each
9 caps. 250 mg each
13 caps. 250 mg each

For children over 3 years old – individually (at the rate of 10-20 mg/kg/day).

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

North Star NAO, Russia