Ursosan forte 500 mg 50 pcs. film-coated tablets

Pharmacodynamics and pharmacokinetics

The composition determines the effect of this medicine. Its active component is ursodeoxycholic acid . Ursodeoxycholic acid has high polar properties and creates non-toxic mixed micelles with toxic bile acids. This leads to a decrease in the ability of gastric reflux to damage cell membranes with the appearance of reflux esophagitis and biliary reflux gastritis . In addition, the drug Ursosan creates double molecules that enter the cell membranes of hepatocytes, epithelial cells of the gastrointestinal tract, and cholangiocytes. These molecules stabilize them and make them immune to the influence of cytotoxic micelles.

The active substance of the drug also reduces the content of bile acids, which are toxic to hepatocytes, and stimulates choleresis, saturated with bicarbonates. Thanks to this, intrahepatic cholestasis disappears. Ursodeoxycholic acid reduces the lithogenic index of bile and cholesterol by preventing its absorption in the intestine, reducing secretion in bile, and inhibiting synthesis in the liver. As a result, cholesterol gallstones dissolve. The product also prevents the appearance of new stones.

The drug acts as an immunomodulatory agent by inhibiting the expression of HLA-2 and HLA-1 and improving the normal killer activity of lymphocytes . In addition, it prevents the development of fibrosis in people with primary biliary cirrhosis , as well as alcoholic steatohepatitis and cystic fibrosis . Reduces the likelihood of varicose veins in the esophagus, slows down premature aging and cell death.

The active substance of the drug is absorbed from the small intestine by passive diffusion (absorption rate is approximately 90%), and in the ileum by active transport. The maximum concentration is reached after approximately 60-180 minutes.

The degree of binding to plasma proteins is up to 99%. With chronic use, ursodeoxycholic acid becomes the main bile acid in the blood serum. The therapeutic effect of the drug depends on its content in bile.

The drug is broken down in the liver with the formation of metabolic such as glycine and taurine conjugate. They are secreted into bile. Approximately 60% of the total dosage is excreted in bile. Some of the active substance is also transported to the colon, where it is broken down by bacteria. Lithocholic acid is absorbed to a small extent from the colon, sulfated in the liver and excreted as sulfolithocholylglycine or sulfolitocholyltaurine conjugate.

Ursosan forte 500 mg 50 pcs. film-coated tablets

pharmachologic effect

Hepatoprotective agent.

Composition and release form Ursosan forte 500 mg 50 pcs. film-coated tablets

Tablets - 1 tablet:

• Active substance: Ursodeoxycholic acid - 500.00 mg;
• Excipients (core): Corn starch; Pregelatinized corn starch; Sodium carboxymethyl starch (type A); Colloidal silicon dioxide; Magnesium stearate;
• Excipients (shell): Opadry white 03B28796; Containing hypromellose 6; Titanium dioxide; Macrogol 400.

Film-coated tablets, 500 mg. 10 tablets per blister pack (blister) made of PVC/PVDC/aluminum foil. 1, 5 or 10 blister packs (blisters) together with instructions for use are placed in a cardboard box.

Description of the dosage form

Film-coated tablets, white or almost white, biconvex, oblong in shape, scored on one side and a deep dividing line on the other side. On the break it is white or almost white.

Directions for use and doses

Orally, during or after meals, without chewing, with plenty of water.

To ensure the recommended dosage, the tablet should be divided in half, breaking at the score. Segments broken incorrectly should not be used. When holding the segment in the mouth, a bitter taste is felt.

To dissolve cholesterol gallstones, the average daily dose of the drug is 10 mg/kg body weight, which corresponds to:

During the first 3 months of treatment, the daily dose should be divided into several doses. 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 re-formation of stones, it is recommended to use the drug for several months after the stones have dissolved.

For chronic hepatitis of various origins (toxic, medicinal, etc.), non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, alcoholic liver disease, the average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy is 6-12 months or more.

For cholestatic liver diseases of various origins, including primary biliary cirrhosis (in the absence of signs of decompensation), the daily dose depends on body weight and ranges from 1 ½ to 3 ½ tablets (14 ± 2 mg UDCA per 1 kg of body weight). During the first three months of treatment, the intake of URSOSAN® FORTE tablets should be distributed throughout the day. If liver test values ​​improve, the daily dose can be taken once a day in the evening.

Pharmacodynamics

A hepatoprotective agent, it also has choleretic, cholelitholytic, hypocholesterolemic and immunomodulatory effects.

Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with lipophilic (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in cholestatic liver diseases and biliary reflux gastritis.

In cholestasis, UDCA activates Ca2+-dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases. By reducing their concentration and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. 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.

Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly through the mobilization of cholesterol from gallstones; reduces the lithogenic index of bile, increases the concentration of bile acids in it. The result is partial or complete dissolution of cholesterol gallstones.

Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect.

The immunomodulatory effect of UDCA is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of T-lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), firstly turn – IgM; regulation of apoptosis of hepatocytes and epithelial cells of the gastrointestinal tract. Delays the progression of fibrosis. Regulates the processes of apoptosis of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract.

Pediatric population

Cystic fibrosis (cystic fibrosis)

According to clinical reports, there is many years of experience (up to 10 years or more) in treating pediatric patients with cystic fibrosis-associated hepatobiliary disease (CFAHD) with ursodeoxycholic acid. There is evidence that ursodeoxycholic acid therapy can reduce bile duct proliferation, slow the development of lesions detected by histological examination, and even promote the reversal of changes in the hepatobiliary system if therapy is started in the early stages of CFAHD. To optimize treatment effectiveness, ursodeoxycholic acid therapy should be initiated as soon as possible after the diagnosis of CFAHD.

Pharmacokinetics

Following oral administration, UDCA is rapidly absorbed from the jejunum and proximal ileum by passive diffusion and from the distal ileum by active transport. Approximately 60-80% is absorbed.

With systematic use of the drug, ursodeoxycholic acid becomes the main bile acid in the blood serum. Depending on the daily dose, type of disease or liver condition, more or less UDCA accumulates in the bile. At the same time, there is a relative decrease in the content of other more lipophilic bile acids.

Metabolized in the liver (clearance during the “primary passage” through the liver is up to 60%) into taurine and glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted in the bile. A small amount of UDCA that is not absorbed in the small intestine enters the large intestine, where it is broken down by bacteria (7-dehydroxylation) to form 7-keto-lithocholic and lithocholic acids. Lithocholic acid is hepatotoxic and causes damage to the liver parenchyma in some animal species. In the human body, it is absorbed only in small quantities, sulfated in the liver into sulfolitocholylglycine or sulfolitocholyltaurine conjugate and thus detoxified before excretion into bile and excretion in feces. The half-life of ursodeoxycholic acid is 3.5-5.8 days.

Indications for use Ursosan forte 500 mg 50 pcs. film-coated tablets

• Uncomplicated cholelithiasis (GSD): biliary sludge; dissolution of cholesterol gallstones with a functioning gallbladder;
• Chronic hepatitis of various origins (toxic, medicinal, etc.);
• Cholestatic liver diseases of various origins, including primary biliary cirrhosis (in the absence of signs of decompensation), primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis);
• Non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis;
• Alcoholic liver disease;
• Biliary dyskinesia;
• Biliary reflux gastritis.

Contraindications

• X-ray positive (high calcium) gallstones;
• Impaired contractility of the gallbladder;
• Acute inflammatory diseases of the gallbladder and bile ducts;
• Occlusion of the biliary tract (occlusion of the common bile or cystic duct);
• Frequent episodes of biliary colic;
• Liver cirrhosis in the stage of decompensation;
• Severe liver and/or renal failure;
• Hypersensitivity to the active and auxiliary components of the drug or other bile acids.

Pediatric population

Unsuccessfully performed portoenterostomy or cases of failure to restore normal bile flow in children with biliary atresia.

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. It is also not recommended for those who have problems swallowing tablets.

Application of Ursosan forte 500 mg 50 pcs. film-coated tablets during pregnancy and breastfeeding

Fertility

According to animal studies, ursodeoxycholic acid has no effect on fertility. There are no data on the effects of ursodeoxycholic acid treatment on fertility in humans.

The use of the drug by women of childbearing potential is only possible if they use reliable methods of contraception.

It is recommended to use non-hormonal contraceptives or oral contraceptives with low estrogen content, since hormonal oral contraceptives may increase gallstone formation. Before starting treatment, possible pregnancy should be excluded.

Pregnancy

There have been no adequate and strictly controlled studies of the use of ursodeoxycholic acid in pregnant women. Animal studies have shown reproductive toxicity in early pregnancy.

During pregnancy, URSOSAN®FORTE should not be used. The use of URSOSAN®FORTE during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk of side effects in the fetus or newborn.

Breast-feeding

Based on several documented case reports, the level of ursodeoxycholic acid in breast milk in women is very low and therefore adverse reactions are not expected in breastfed infants.

special instructions

Taking the drug URSOSAN®FORTE should be carried out under the supervision of a doctor.

The use of the drug for the purpose of dissolving gallstones is possible subject to the following conditions: the stones must be cholesterol (X-ray negative), their size is no more than 15-20 mm, a functioning gallbladder with preserved patency of the cystic and common bile ducts, no more than half filled with gallstones .

With long-term use of the drug to dissolve gallstones, a biochemical blood test should be performed every 4 weeks in the first 3 months of treatment, and every 3 months thereafter, to determine the activity of microsomal liver enzymes (transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase).

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.

When used in patients to dissolve cholesterol gallstones.

In order to assess progress in treatment and for the timely detection of signs of calcification of stones depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine position (ultrasound examination) after 6- 10 months after the start of treatment.

If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder or frequent attacks of colic, URSOSAN®FORTE should not be used.

When treating patients in the later 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.

In patients with primary biliary cirrhosis, in rare cases, at the beginning of treatment, clinical symptoms may increase, for example, itching may increase. In this case, the dose of the drug must be reduced to 250 mg (1/2 tablet), and then gradually increased again, as described in the “Method of administration and dosage” section.

Use in patients with primary sclerosing cholangitis

Long-term therapy with high doses of ursodeoxycholic acid (28-30 mg/kg/day) in patients with this pathology can cause serious side effects.

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

Women of reproductive age should take URSOSAN®FORTE while using reliable contraception. It is recommended to use non-hormonal contraceptives or oral contraceptives with low estrogen content, since hormonal oral contraceptives may increase gallstone formation. Before starting treatment, possible pregnancy should be excluded.

Impact on the ability to drive vehicles and moving machinery

The use of the drug URSOSAN®FORTE does not affect the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (the ability to drive vehicles, work with moving mechanisms, etc.).

Overdose

In case of overdose, diarrhea may occur. In case of established, prolonged diarrhea, drug therapy should be discontinued. Treatment of diarrhea is symptomatic (restoration of water and electrolyte balance).

Other symptoms of overdose are unlikely because the resorption of ursodeoxycholic acid worsens as the dose increases, leading to increased excretion in the feces.

Side effects Ursosan forte 500 mg 50 pcs. film-coated tablets

The frequency of occurrence of side effects (number of cases/number of observations) in accordance with the classification of the World Health Organization is presented in the following gradation: very often (≥ 1/10); often (≥ 1/100 to

Gastrointestinal disorders:

In clinical studies, diarrhea or loose stools were frequently observed during treatment with ursodeoxycholic acid.

During the treatment of primary biliary cirrhosis, acute pain in the right upper abdomen was very rarely observed.

Disorders of the liver and biliary tract:

During treatment with ursodeoxycholic acid, calcification of gallstones has been observed in very rare cases.

In the treatment of primary biliary cirrhosis in the later stages, in very rare cases, decompensation of liver cirrhosis was observed, which regressed after discontinuation of the drug.

Disorders of the skin and subcutaneous tissues:

In very rare cases, allergic reactions, including urticaria, may occur.

If any of the side effects indicated in the instructions get worse, or you notice other side effects not listed in the instructions, please tell your doctor.

Drug interactions

The drug should not be used simultaneously with antacids containing aluminum hydroxide or smectite (aluminum oxide), ion exchange resins (cholestyramine, colestipol), since these drugs can 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 still necessary, they should be taken 2 hours before or 2 hours after taking URSOSAN®FORTE.

Ursodeoxycholic acid may increase the absorption of cyclosporine from the intestine, which requires monitoring the concentration of cyclosporine in the blood plasma and, if necessary, adjusting its dosage regimen.

In some cases, ursodeoxycholic acid may reduce the absorption of ciprofloxacin.

In a clinical study involving healthy volunteers, simultaneous use of ursodeoxycholic acid (500 mg/day) and rosuvastatin (20 mg/day) led to a slight increase in rosuvastatin plasma levels. The clinical significance of this interaction, including with other statins, is unknown.

Ursodeoxycholic acid has been shown to reduce the maximum concentration and area under the pharmacokinetic concentration-time curve of the calcium antagonist nitrendipine. In case of concomitant use of nitrendipine and ursodeoxycholic acid, careful monitoring is recommended. The dose of nitrendipine may need to be increased. In addition, a decrease in the therapeutic effect of dapsone has been reported.

These data, as well as in vitro data, suggest that ursodeoxycholic acid may induce CYP3A isoenzymes. However, the results of controlled clinical studies indicate that ursodeoxycholic acid does not have a significant inducing effect on the CYP3A isoenzyme.

Some medications, such as estrogens, progestogens (oral contraceptives), neomycin, clofibrate, can increase cholelithiasis, thereby having the opposite effect of the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.

Indications for use of Ursosan

On forums people often ask what pills can help with in this or that case. Experts do not recommend taking them without consulting a doctor. Only he can determine whether there are indications for the use of Ursosan. In addition, he selects the desired treatment regimen.

If you have been prescribed Ursosan tablets, the indications for use are usually as follows:

• uncomplicated cholelithiasis ;
• the need to prevent recurrent stone formation after cholecystectomy ;
• acute hepatitis;
• alcohol disease and primary biliary cirrhosis ;
• biliary dyskinesia
• cystic fibrosis of the liver;
• biliary dyspeptic syndrome;
• toxic liver damage;
• chronic active hepatitis ;
• non-alcoholic steatohepatitis;
• atresia of the intrahepatic biliary tract;
• primary sclerosing cholangitis ;
• biliary reflux gastritis and reflux esophagitis ;
• the need to prevent liver damage when taking hormonal contraceptives and cytostatics.

Ursosan forte, 500 mg, film-coated tablets, 10 pcs.

Hepatoprotective drug. It also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and immunomodulatory effects. Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with lipophilic (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in cholestatic liver diseases, biliary reflux gastritis and reflux esophagitis.

In cholestasis, UDCA activates Ca 2 -dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases. By reducing their concentration and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. 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.

Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly due to the dispersion of cholesterol and the formation of liquid crystals; reduces the lithogenic index of bile, increases the concentration of bile acids in it. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones.

Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect.

The immunomodulatory effect of UDCA is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), primarily - IgM; regulation of apoptosis of hepatocytes and epithelial cells of the gastrointestinal tract. Delays the progression of fibrosis.

Contraindications

This drug should not be used in case of hypersensitivity to its components, non-functioning gallbladder, chronic hepatitis , pancreatitis , acute cholecystitis , liver cirrhosis (with decompensation), acute cholangitis , acute infectious diseases of the gallbladder, diseases of the bile ducts, pregnancy , breastfeeding , bile -gastrointestinal fistula, gallstones with high Ca2+ content, inflammatory diseases of the small and large intestines, liver failure , renal failure , empyema of the gallbladder, obstruction of the biliary tract.

Ursosan forte tablet p/o film 500mg 100 pcs

Pharmacological group:

Hepatoprotective agent ATC code: A05AA02
Pharmacodynamics:
Hepatoprotective agent, also has choleretic, cholelitholytic, hypocholesterolemic and immunomodulatory effects.

Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with lipophilic (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in cholestatic liver diseases and biliary reflux gastritis.

In cholestasis, UDCA activates Ca2+-dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases. By reducing their concentration and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. 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.

Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly through the mobilization of cholesterol from gallstones; reduces the lithogenic index of bile, increases the concentration of bile acids in it. The result is partial or complete dissolution of cholesterol gallstones.

Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect.

The immunomodulatory effect of UDCA is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of T-lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), firstly turn – IgM; regulation of apoptosis of hepatocytes and epithelial cells of the gastrointestinal tract. Delays the progression of fibrosis. Regulates the processes of apoptosis of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract.

Pediatric population.

Cystic Fibrosis: According to clinical reports, there is many years of experience (up to 10 years or more) in treating pediatric patients with cystic fibrosis-associated hepatobiliary disease (CFAHD) with ursodeoxycholic acid. There is evidence that ursodeoxycholic acid therapy can reduce bile duct proliferation, slow the development of lesions detected by histological examination, and even promote the reversal of changes in the hepatobiliary system if therapy is started in the early stages of CFAHD. To optimize treatment efficacy, ursodeoxycholic acid therapy should be initiated as soon as possible after the diagnosis of CFAHD.

Pharmacokinetics:

Following oral administration, UDCA is rapidly absorbed from the jejunum and proximal ileum by passive diffusion and from the distal ileum by active transport. Approximately 60-80% is absorbed.

With systematic use of the drug, ursodeoxycholic acid becomes the main bile acid in the blood serum. Depending on the daily dose, type of disease or liver condition, more or less UDCA accumulates in the bile. At the same time, there is a relative decrease in the content of other more lipophilic bile acids.

Metabolized in the liver (clearance during the “primary passage” through the liver is up to 60%) into taurine and glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted in the bile. A small amount of UDCA that is not absorbed in the small intestine enters the large intestine, where it is broken down by bacteria (7-dehydroxylation) to form 7-keto-lithocholic and lithocholic acids. Lithocholic acid is hepatotoxic and causes damage to the liver parenchyma in some animal species. In the human body, it is absorbed only in small quantities, sulfated in the liver into sulfolitocholylglycine or sulfolitocholyltaurine conjugate and thus detoxified before excretion into bile and excretion in feces. The half-life of ursodeoxycholic acid is 3.5-5.8 days.

Side effects of Ursosan

Reviews of side effects appear infrequently. However, if any unwanted reactions occur, you should definitely consult a doctor.

The following side effects of Ursosan are known:

• vomit;
• exacerbation of psoriasis ;
• nausea;
• diarrhea;
• transient increase in the activity of liver transaminases;
• constipation;
• painful sensations in the back;
• allergy;
• alopecia.

In rare cases, gallstones may become calcified.

Instructions for use of Ursosan (Method and dosage)

For those who have been prescribed Ursosan tablets, the instructions for use indicate that they should be taken orally with liquid.

The medicine has different dosage regimens depending on the disease. For those who are interested in how to take Ursosan: before or after meals, it is also reported that this is individual, depending on the indications for use.

In the case of diffuse liver diseases and cholelithiasis , the course of treatment can last from several months to several years, the daily dosage is usually 10-15 mg per 1 kg of the patient’s body weight (2-5 capsules). For cholelithiasis, the daily dosage is taken once immediately before bedtime. Treatment is carried out until the stones dissolve, and then another 3 months to ensure that the stones do not form again. For diffuse liver diseases, the instructions for use of Ursosan indicate that the daily dosage should be divided into 2-3 doses. The product should be taken during meals.

After cholecystectomy and for the purpose of preventing recurrent cholelithiasis , 250 mg is usually prescribed 2 times a day. The course lasts several months.

For primary biliary cirrhosis, the medicine is taken in a dosage of 10-15 mg per 1 kg of patient body weight per day. If necessary, it can be increased to 20 mg per 1 kg. The dosage should be divided into 2-3 doses. The course of treatment lasts from 6 months to several years.

If the patient has non-alcoholic steatohepatitis , take 13-15 mg per 1 kg of the patient’s weight per day. The dosage should be divided into 2-3 doses. The course of treatment can last from 6 months to several years.

In the case of biliary reflux gastritis and reflux esophagitis, the medicine is taken 1 capsule (250 mg) per day immediately before bedtime. Therapy is carried out from 10 days to 6 months. If necessary, it can be extended up to 2 years.

For liver damage , biliary atresia alcoholic liver disease, the daily dosage is usually 10-15 mg per 1 kg of patient weight. The daily dosage should be divided into 2-3 doses. The course is designed for six months, a year or more.

If the patient has primary sclerosing cholangitis , the doctor usually prescribes 12-15 mg per 1 kg of the patient’s body weight per day. If necessary, the dosage can be increased to 20 mg per 1 kg of weight. The total daily dose is divided by the patient into 2-3 doses. The course of admission is from six months to several years.

For cystic fibrosis, the drug is taken in dosages of 20-30 mg per kg per day. The dose should be divided into 2-3 doses. The course lasts from six months to several years.

For children over 2 years old, the amount of the drug taken per day is determined individually by a specialist. Typically 10-20 mg per kg per day is prescribed.

In order to eliminate severe and dangerous jaundice, specialists in some cases prescribe this remedy to newborns. Therapy is designed for 2-4 weeks. Instructions for use of Ursosan for newborns indicate that the dosage for children of this age is a quarter of a capsule every day. The powder in it is poured onto a saucer. Then it is divided into four equal parts, one of which is given to the baby. It must first be dissolved in water or breast milk. If treatment is successful, the course can be reduced to 10 days. In this case, you need to monitor the level of bilirubin in the blood every week. On average, its level decreases by 50 units per week. Once the blood concentration reaches 100 mg/ml, the medicine can be discontinued.

Ursosan Tablets, box, 50 pcs, 500 mg, for oral administration, film-coated

Pharmacological properties

Hepatoprotective drug.
It also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and immunomodulatory effects. Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with lipophilic (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in cholestatic liver diseases, biliary reflux gastritis and reflux esophagitis. In cholestasis, UDCA activates Ca2-dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases. By reducing their concentration and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. 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.

Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly due to the dispersion of cholesterol and the formation of liquid crystals; reduces the lithogenic index of bile, increases the concentration of bile acids in it. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones.

Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect.

The immunomodulatory effect of UDCA is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), primarily - IgM; regulation of apoptosis of hepatocytes and epithelial cells of the gastrointestinal tract. Delays the progression of fibrosis.

Pharmacokinetics

Suction and distribution

UDCA is absorbed in the jejunum and upper ileum by passive diffusion (about 90%), and in the terminal ileum by active transport. The resorption rate is usually 60-80%.

When 50 mg of UDCA is taken orally, Cmax after 30, 60, 90 minutes is 3.8 mmol/L, 5.5 mmol/L and 3.7 mmol/L, respectively. The time to reach Cmax is 1-3 hours. Plasma protein binding is high - up to 96-99%. Penetrates through the placental barrier.

When taking the drug systematically, UDCA becomes the main bile acid in the blood serum.

Metabolism and excretion

Metabolized in the liver (first-pass clearance through the liver is up to 60%) into taurine and glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted in the bile. A small amount of UDCA that is not absorbed in the small intestine enters the large intestine, where it is broken down by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, sulfated in the liver and quickly excreted in the bile in the form of sulfolitocholylglycine or sulfolitocholyltaurine conjugate.

Analogues of Ursosan

Level 4 ATC code matches:
Ursodex

Henofalk

Ursoliv

Ursofalk

Choludexan

Ursohol

Ursodez

Urdoxa

Livodex

The names of analogues of this drug are presented in the following list:

• Ursolak
• Ursoliv
• Ursolysin
• Ursomax
• Ursonost
• Ursofalk
• Ursohol
• Essentiale
• Choludexan

All analogues of Ursosan have their own characteristics of action and application. None of them should be replaced independently without consulting a doctor. The price of analogues may vary depending on the amount of medicine in one package. However, in most cases their cost is higher than the described drug in a similar quantity.

Let's take a closer look at some Ursosan analogues.

Ursofalk or Ursosan - which is better?

In most cases, when choosing between these two drugs, experts believe that the first remedy is better. This has been confirmed by many clinical observations, patient reviews and many years of practice. People who have taken both drugs note that Ursofalk is easier to tolerate. And experts report that it dissolves gallstones faster and improves liver condition.

However, the difference between Ursosan and Ursofalk for each specific case can only be understood in practice. There are people for whom a medicine like Ursosan is more suitable. So you can first prescribe a course of Ursofalk, and, if the treatment is not effective enough, move on to another drug. In this way, the best treatment method can be selected.

Ursosan or Essentiale - which is better?

As a hepatoprotector , Essentiale is much more effective in maintaining liver function. In addition, this remedy does not have as many side effects. So for those who choose the drug when it is necessary to normalize liver function, doctors in most cases recommend a second remedy. Ursosan is more expensive and has less effect on the cellular structure.

Urdoxa or Ursosan - which is better?

Urdoxa is a domestically produced product, which is a generic version of Ursosan. However, all the necessary components for its manufacture are purchased abroad. Thus, all the components in it are the same as in the original drug. In fact, these are complete analogues, and the difference between them lies only in the country of origin. Many, however, choose a domestic product, since its cost is much lower.

Ursoliv or Ursosan - which is better?

Both drugs have the same main component. Some patients tolerate one drug better, while others tolerate the other. In this situation, individual effectiveness can only be verified in practice. All this depends on the characteristics of the body, so you should start taking one of the remedies, and if it does not help, move on to another. There are no objective signs to help determine the effectiveness of each of these drugs. Many patients prefer to try each of the remedies and then choose the most effective one.

Ursosan Forte 500 mg No. 30 tablet

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE URSOSAN® FORTE URSOSAN® FORTE Trade name: URSOSAN® FORTE Active substance (INN): ursodeoxycholic acid Dosage form: film-coated tablets, 500 mg Composition: One film-coated tablet contains: active substance: 500 mg ursodeoxycholic acid (UDCA) excipients (core): corn starch, pregelatinized corn starch, sodium carboxymethyl starch (type A), colloidal silicon dioxide, magnesium stearate. excipients (shell): opadry white (03B28796): hypromellose 6, titanium dioxide (E 171), macrogol 400, purified water Description: Oblong-shaped tablets, film-coated, almost white in color with a dividing cross mark. Pharmacotherapeutic group: hepatoprotector, cholelitholytic agents. ATX code: A05AA02. Pharmacological properties Pharmacodynamics Hepatoprotective agent, also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and some immunomodulatory effects. Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in biliary reflux gastritis and reflux esophagitis. By reducing concentrations and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. In case of cholestasis, it activates Ca2+-dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), 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. Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly due to the dispersion of cholesterol and the formation of liquid crystals; reduces the lithogenic index of bile, increases the concentration of bile acids in it. 2 The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones. Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. The immunomodulatory effect is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), primarily IgM . Delays the progression of fibrosis. Regulates the processes of apoptosis of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract. Pharmacokinetics UDCA is absorbed in the small intestine by passive diffusion (about 90%), and in the ileum by active transport. The maximum concentration in blood plasma (Cmax) after oral administration of 50 mg after 30, 60, 90 minutes is 3.8 mmol/l, 5.5 mmol/l and 3.7 mmol/l, respectively. The time to reach maximum plasma concentration (TCmax) is achieved after 1-3 hours. The connection with plasma proteins is high - up to 96-99%. Penetrates through the placental barrier. When taking the drug systematically, UDCA becomes the main bile acid in the blood serum. Metabolized in the liver (clearance during the “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 in the bile. A small amount of unabsorbed UDCA enters the colon, where it is broken down by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and quickly excreted in the form of sulfolithocholylglycine or sulfolitocholyltaurine conjugate. Preclinical Safety Data Preclinical Safety Data Acute Toxicity Acute toxicity studies in animals did not show any toxic damage. Chronic toxicity In subchronic toxicity studies in monkeys, hepatotoxic effects including functional changes (eg, changes in liver enzymes) as well as morphological changes, such as bile duct proliferation, portal inflammation and hepatocellular necrosis, were documented in high-dose groups in monkeys. This toxicity is most likely attributable to lithocholic acid, a metabolite of ursodeoxycholic acid, which is not detoxified in monkeys, unlike humans. Clinical experience shows that the described hepatotoxic effects in humans do not play any obvious role. Carcinogenic and mutagenic potential In long-term studies in mice and rats, no evidence was found to support the carcinogenic potential of ursodeoxycholic acid. In vitro and in vivo genotoxicity studies of ursodeoxycholic acid were negative. Reproductive toxicity 3 In studies on rats, tail aplasia occurred at a dose of 2000 mg of ursodeoxycholic acid per 1 kg of body weight. In rabbits, no teratogenic effects were identified, although embryotoxic effects were noted (starting with a dose of 100 mg per 1 kg of body weight). Ursodeoxycholic acid had no effect on the fertility of rats and the peri- and postnatal development of the pups. Indications for use • Gallstone disease (GSD): biliary sludge; dissolution of cholesterol gallstones with a functioning gallbladder in patients with high surgical risk and in patients after lithotripsy. The condition for successful treatment is a functioning gallbladder and the presence of clean radiotransparent cholesterol stones, the diameter of which does not exceed 15 mm; prevention of recurrent stone formation after cholecystectomy. Cholestatic liver diseases of various origins, including: • Primary biliary cirrhosis stages I and II. • Primary sclerosing cholangitis. • Hepatitis (chronic and acute viral, atypical forms of chronic autoimmune). • Non-alcoholic fatty liver disease. Non-alcoholic steatohepatitis. • Toxic liver damage (including alcohol, drugs). • Biliary dyspepsia. • Bile reflux gastritis and esophagitis. • Cystic fibrosis. • Biliary dyskinesia. • Chronic opisthorchiasis. Contraindications • hypersensitivity to bile acids or any excipient included in the drug • acute inflammatory diseases of the gallbladder or bile ducts • obstruction of the bile ducts (obstruction of the common bile duct or cystic bile duct) • frequent attacks of biliary colic • X-ray positive (with high content calcium) gallstones; Pediatric population • portoenterostomy that did not lead to a successful result, or if a sufficient bile duct was not restored in children with bile duct atresia Side effects The frequency of occurrence of side effects (number of cases/number of observations) is presented as the following gradation: very often (≥ 1/ 10); often (≥ 1/100 to infrequently (≥ 1/1000 to unknown (frequency cannot be calculated from available data). Gastrointestinal tract In clinical studies, diarrhea or pasty stools were often observed during treatment with ursodeoxycholic acid. During the treatment of primary biliary cirrhosis, severe pain in the upper abdomen was very rarely observed. From the liver and biliary tract During treatment with ursodeoxycholic acid, in very rare cases, calcification of gallstones was observed. 4 When treating primary biliary cirrhosis in the later stages, decompensation of liver cirrhosis was observed in very rare cases, which has regressed after cessation of treatment Skin and subcutaneous tissues In very rare cases, urticaria may occur Reporting suspected side effects Suspected side effects should be reported after the drug has been approved. Such reports help to continue monitoring the balance of benefits and risks of the drug . We ask medical workers to send reports of suspected side effects to the following address: Department of Drug Supply and Medical Equipment under the Ministry of Health of the Kyrgyz Republic (DLO and MT Ministry of Health of the Kyrgyz Republic) at the address: Bishkek, st. 3-line, 25. Drug interactions Ursosan® Forte film-coated tablets should not be prescribed concomitantly with cholestyramine, cholestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), since these drugs bind UDCA in the intestines and, therefore, , inhibit its absorption and effectiveness. These medications should be taken no earlier than 2 hours before or 2 hours after taking Ursosan® Forte film-coated tablets. Ursosan® Forte film-coated tablets may affect the absorption of cyclosporine from the intestine, which requires monitoring the concentration of cyclosporine in the blood plasma and, if necessary, adjusting its dosage regimen. In some cases, ursodeoxycholic acid may reduce the absorption of ciprofloxacin. Concomitant administration of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in a mild increase in plasma rosuvastatin levels. The clinical relevance of this interaction, including with other statins, is unknown. There is evidence that UDCA reduces the peak plasma concentration (Cmax) and area under the pharmacokinetic curve (AUC) of the calcium antagonist nitrendipine, which requires monitoring of nitrendipine concentrations. The need to increase the dose of nitrendipine cannot be ruled out. There is evidence that the interaction of UDCA and dapsone leads to a decrease in the effect of the latter. These observations may indicate the potential of UDCA to induce cytochrome P450 ZA enzymes. However, induction was not observed in a thorough study of the interaction of UDCA with budesonide, a known cytochrome P450 3A substrate. Some medications, such as estrogens, progestogens (oral contraceptives), neomycin, clofibrate, can increase cholelithiasis, thereby having the opposite effect of the ability of ursodeoxycholic acid to dissolve cholesterol gallstones. Method of administration and dosage Directions for use: Orally, during or after meals, without chewing, with a sufficient amount of water. To ensure the recommended dosage, the tablet should be divided in half, breaking at the score. Segments broken incorrectly should not be used. When holding the segment in the mouth, a bitter taste is felt. 5 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. Take regularly. The dose and duration of treatment are determined individually and depend on the indications and the severity of the patient’s condition. Calculation of the daily number of tablets depending on the patient’s body weight and the recommended dose of the drug per 1 kg of body weight (mg/kg/day) - For dissolving gallstones in adults and for treating conditions caused by stagnation of bile, the recommended dose is from 1 to 3 film-coated tablets daily depending on the patient’s weight (10 mg/kg/day). Body weight (kg) Number of film-coated tablets of the drug Ursosan® Forte, 500 mg (mg) Up to 60 1 61 -80 1 ½ tablet 81-100 2 More than 100 2 Usually taken once in the evening. Treatment should be continued until 2 consecutive cholecystograms and/or ultrasound scans with an interval of 4-12 weeks show the absence of gallstones. If gallstones do not decrease in size after 12 months of treatment, the drug should be discontinued. To prevent re-formation of stones, it is recommended to use the drug for several months after the stones have dissolved. To prevent recurrent cholelithiasis after cholecystectomy, 250 mg (½ film-coated tablet) is prescribed 2 times a day for several months. - After cholecystectomy for the prevention of recurrent cholelithiasis - 8-10 mg/kg/day for several months. — For biliary dyskinesia of the hypokinetic type, the average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment. - For biliary reflux gastritis and reflux esophagitis - 250 mg (½ film-coated tablet) per day, before bedtime. The course of treatment is from 10 - 14 days to 6 months, if necessary - up to 2 years. — Cholestatic liver diseases of various origins, including Primary biliary cirrhosis stages I and II, Primary sclerosing cholangitis. The average daily dose is 1 ½ - 3 ½ film-coated tablets (14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight). During the first three months of treatment, Ursosan® Forte film-coated tablets should be distributed throughout the day. If clinical symptoms worsen at the beginning of treatment (increased itching), treatment should be continued by taking ½ Ursosan® Forte film-coated tablets daily, then the dosage should be gradually increased (increasing the daily dose weekly by ½ film-coated tablets) until until the recommended dosage regimen is achieved again. — For chronic hepatitis of various origins (viral, toxic, medicinal, etc.), chronic viral hepatitis, non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, alcoholic liver disease, the average daily dose is 10-15 mg/kg in 2-3 reception. The duration of therapy is 6-12 months or more. For ease of dosing, you can use the following data: Body weight (kg) Daily dose (mg/kg body weight) Ursosan® Forte 500 mg, film-coated tablets First 3 months then morning lunch evening evening (once a day) 47 - 62 ½ ½ ½ 1 ½ 63 - 78 ½ ½ 1 2 79 - 93 ½ 1 1 2 ½ 94 - 109 1 1 1 3 over 110 1 1 1 ½ 3½ Children's population (6-18 years old) Hepatobiliary disorder in cystic fibrosis (cystic fibrosis) Children with cystic fibrosis ages 6 to 18 years: 20 mg/kg/day in 2 to 3 divided doses, further increased to 30 mg/kg/day as needed. Body weight (kg) Daily dose (mg/kg body weight) Ursosan® Forte 500 mg film-coated tablets morning lunch evening 20 - 29 17 - 25 ½ - ½ 30 - 39 19 -25 ½ ½ ½ 40 - 49 20 - 25 ½ ½ 1 50 - 59 21 - 25 ½ 1 1 60 - 69 22 - 25 1 1 1 70 - 79 22 - 25 1 1 1½ 80 - 89 22 - 25 1 1½ 1½ 90 - 99 23 - 25 1½ 1½ 1½ 100 — 109 23 — 25 1½ 1½ 2 over 110 1½ 2 2 Overdose In case of overdose, diarrhea may occur. In case of established, prolonged diarrhea, drug therapy should be discontinued. Other symptoms of overdose are unlikely because the resorption of ursodeoxycholic acid worsens as the dose increases, leading to increased excretion in the feces. Treatment is symptomatic. Special instructions Ursosan® Forte, film-coated tablets should be taken as prescribed by a doctor. 7 During the first three months of treatment, the physician should check liver function tests AST (SGOT), ALT (SGPT), and GGT (y-GT) every 4 weeks and subsequently every 3 months. While this will allow the identification of responders and non-responders among the population of patients undergoing treatment, it will also allow early detection of potential liver damage, particularly in patients with advanced PBC. When used to dissolve cholesterol gallstones: To assess the progress of treatment, as well as to promptly detect any calcification of gallstones, depending on the size of the stone, it is necessary to visualize the gallbladder (oral cholecystography) - general appearance and occlusion in the standing and lying position back (check using ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on an x-ray, or if there are calcified gallstones, impaired contractility of the gallbladder, or frequent episodes of biliary colic, Ursosan® Forte should not be used. When used to treat late-stage primary biliary cirrhosis: In very rare cases, decompensation of liver cirrhosis has been observed with partial regression after cessation of treatment. In rare cases, patients with PBC may experience a worsening of clinical symptoms at the start of treatment, i.e. itching may worsen. In this case, the dosage should be reduced to 250 mg (1/2 film-coated tablet) per day and gradually increased to the recommended dose indicated in the “Dosage and Administration” section. In case of diarrhea, the dose should be reduced, and in cases of persistent diarrhea, treatment should be discontinued. Use during pregnancy and breastfeeding There are no data on the effect on fertility after treatment with UDCA. There are no or limited data on the use of ursodeoxycholic acid in pregnant patients. There is evidence of a teratogenic effect during the early phase of pregnancy. The use of UDCA during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk of side effects in the fetus or newborn (there have been no adequate and strictly controlled studies of the use of ursodeoxycholic acid in pregnant women). Women of childbearing age should take the drug only while using reliable contraception. It is recommended to use non-hormonal or low estrogen methods of contraception. In patients taking Ursosan® Forte, tablets covered with a film membrane, 500 mg, in order to dissolve the bile stones, non -hormonal methods of contraception should be used, since hormonal contraceptives can contribute to the formation of stones. The possibility of pregnancy should be excluded before the start of treatment. According to several confirmed cases, the concentration of ursodeoxichole acid in milk of nursing women is small; The occurrence of undesirable reactions in children against the backdrop of breastfeeding is unlikely. Storage conditions are stored in original packaging at a temperature of not higher than 25ºС. Keep out of the reach of children! Shelf life: 4 years. 8 Do not apply after the expiration date indicated on the packaging! The output form of 10 tablets covered with a film shell is placed in contour cell packages from the polyvinyl chloride film and aluminum foil. 1, 2, 3, 5, 6, 9 or 10 contour packages, along with the instructions for medical use in the state and Russian languages, are placed in a cardboard pack on sale, all types of packages are released from pharmacies are released according to the doctor’s prescription! Manufacturer/owner of the registration certificate of pro. Med.CS Prague A.O. Telchsk 377/1, Mikhle 140 00, Prague 4, Czech Republic.

Reviews about Ursosan

Reviews of drug treatment can often be found on specialized forums. Doctors also express their opinions. They note the effectiveness of this drug. Patient reviews are also mostly positive. Some also take it as a prophylactic in cases where a large load on the liver is expected.

With regard to use for newborns, doctors' reviews of Ursosan usually report that the treatment was effective. Parents turn to them when their children develop jaundice. Those who gave the medicine according to the specialist’s instructions leave reviews about Ursosan, which say that the drug helped.

Ursosan Forte tablet p/p/o 500 mg N50 (ProMed)

Hepatoprotective drug. It also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and immunomodulatory effects. Possessing high polar properties, ursodeoxycholic acid (UDCA) is embedded in the membrane of hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract, stabilizes its structure and protects the cell from the damaging effects of toxic bile acid salts, thus reducing their cytotoxic effect. Forms non-toxic mixed micelles with lipophilic (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in cholestatic liver diseases, biliary reflux gastritis and reflux esophagitis. In cholestasis, UDCA activates Ca2-dependent alpha protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases. By reducing their concentration and stimulating bicarbonate-rich choleresis, UDCA effectively promotes the resolution of intrahepatic cholestasis. 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. Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; promotes the gradual disintegration of cholesterol gallstones, which is achieved mainly due to the dispersion of cholesterol and the formation of liquid crystals; reduces the lithogenic index of bile, increases the concentration of bile acids in it. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones. Causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. The immunomodulatory effect of UDCA is due to inhibition of the expression of histocompatibility antigens - HLA-1 - on the membranes of hepatocytes and HLA-2 - on cholangiocytes, normalization of the natural killer activity of lymphocytes, the formation of interleukin-2, a decrease in the number of eosinophils, suppression of immunocompetent immunoglobulins (Ig), primarily - IgM; regulation of apoptosis of hepatocytes and epithelial cells of the gastrointestinal tract. Delays the progression of fibrosis.

Ursosan price, where to buy

This medicine can be bought in Ukraine, Belarus and Russia. How much this drug costs depends largely on the number of capsules in one package.

You can buy this product in Moscow and other Russian cities at the following prices:

• price of Ursosan 100 tablets (250 mg) - approximately 1,500 rubles;
• price of Ursosan 50 capsules – approximately 800 rubles;
• the price of a package of 10 capsules is approximately 200 rubles.

Average price of Ursosan in Ukraine:

• capsules of 50 pieces per package – approximately 600 hryvnia;
• capsules of 100 pieces per package - approximately 1000 hryvnia;
• capsules of 10 pieces per package - approximately 100 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Ursosan capsules 250 mg 50 pcs. ZiO-Zdorovye ZAO
  808 rub. order

Pharmacy Dialogue

• Ursosan (caps. 250 mg No. 10) Pro.Med.Cs.

  RUB 152 order

• Ursosan (tab.p.pl/vol.500mg No. 50)Pro.Med.Cs.

  RUB 1,540 order

• Ursosan (tab.p.pl/vol. 500 mg No. 100) Pro.Med.Cs.

  RUB 3,032 order

• Ursosan (caps. 250 mg No. 10) Pro.Med.Cs.

  170 rub. order

• Ursosan (caps. 250 mg No. 50)ZiO-Zdorovye CJSC

  RUR 797 order

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Pharmacy24

• Ursosan 250 mg No. 100 capsules PRO.MED.CS Prague a.t., Czech Republic/ PRO.MED.CS Prague a.s., Czech Republic
  1022 UAH.order

PaniPharmacy

• Ursosan capsule Ursosan caps. 250 mg No. 50, PRO.MED.CS Prague

  610 UAH. order

• Ursosan capsule Ursosan caps. 250 mg No. 100, PRO.MED.CS Prague

  1048 UAH order

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Ursosan forte film-coated tablets 500 mg No. 100

Directions for use and doses

Orally, during or after meals, without chewing, with plenty of water. To ensure the recommended dosage, the tablet should be divided in half, breaking at the score. Segments broken incorrectly should not be used. When holding the segment in the mouth, a bitter taste is felt. To dissolve cholesterol gallstones, the average daily dose of the drug is 10 mg/kg (up to 12-15 mg/kg). The daily dose of the drug is taken once at night. The course of treatment is 6-12 months or more until the stones are completely dissolved. If gallstones do not decrease in size after 12 months of treatment, the drug should be discontinued. To prevent re-formation of stones, it is recommended to use the drug for several months after the stones have dissolved. To prevent recurrent cholelithiasis after cholecystectomy, 250 mg (1/2 tablet) is prescribed 2 times a day for several months. For chronic hepatitis of various origins (toxic, medicinal, etc.), chronic viral hepatitis, non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, alcoholic liver disease, the average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy is 6-12 months or more. For cholestatic liver diseases of various origins, including primary biliary cirrhosis (in the absence of signs of decompensation), primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis), the average daily dose is 12-15 mg/kg, if necessary - 20-30 mg/kg. During the first 3 months of treatment, the daily dose of the drug should be divided into 2-3 doses. If biochemical blood parameters improve, the daily dose of the drug is taken once at night. The duration of therapy ranges from 6 months to several years. For biliary dyskinesia, the average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment. For biliary reflux gastritis and reflux esophagitis, the average daily dose is 250 mg (14 tablets) once at night. The course of treatment is from 2 weeks to 6 months, if necessary - up to 2 years. Calculation of the daily number of tablets depending on the patient’s body weight and the recommended dose of the drug per 1 kg of body weight, mg/kg/day