Universal reference book for medicines
Name of the preparation: URSOROM ® S (URSOROM S)

Active substance: ursodeoxycholic acid

Type: Hepatoprotector with choleretic and cholelitholytic action

Producer: FarmThirm SOTEKS (Russia) manufactured by SC ROMPHARM Company (Romania) is packed by SOTEX Farm Company (Russia)
Composition, form of production and packaging
Capsules
hard gelatinous, size No. 0, blue, smooth, shiny;
the contents of the capsules are granules of white or almost white color.
1 caps.

ursodeoxycholic acid 250 mg

Excipients: corn starch - 55.5 mg, povidone K30 - 16.25 mg, silicon dioxide colloid - 1.625 mg, magnesium stearate - 1.625 mg.

The composition of the capsule shell: titanium dioxide is 1.94 mg, the dye is blue patented - 0.0153 mg, gelatin is 95.0047 mg.

15 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Hepatoprotective agent.
It also has choleretic, cholelitholitic, hypolipidemic, hypocholesterolemic and some immunomodulating action.
Possessing high polar properties, ursodeoxycholic acid forms nontoxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes with biliary reflux gastritis and reflux esophagitis.

In addition, ursodeoxycholic acid forms double molecules that can be incorporated into cell membranes (hepatocytes, cholangiocytes, GIT), stabilize them and render them immune to the action of cytotoxic micelles.
Reducing the concentration of toxic to the hepatic cell bile acids and stimulating choleresis, bicarbonate-rich ursodeoxycholic acid effectively promotes resolution of intrahepatic cholestasis.
Reduces the saturation of bile with cholesterol due to inhibition of its absorption in the intestine, suppression of synthesis in the liver and a decrease in secretion in bile;
increases the solubility of cholesterol in bile, forming with it liquid crystals; reduces the lithogenic bile index. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new concrements.
Immunostimulating effect is caused by inhibition of expression of HLA-1 antigens on the membranes of hepatocytes and HLA-2 on cholangiocytes, normalization of the natural killer activity of lymphocytes.

Reliably delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis;
reduces the risk of developing varicose veins of the esophagus


PHARMACOKINETICS

Suction

After taking the drug inside, ursodeoxycholic acid is absorbed from the small intestine due to passive diffusion (about 90%), and in the ileum through active transport.When administered orally at a dose of 500 mg after 30, 60, 90 min C max in blood plasma is 3.8 mmol / l, 5.5 mmol / l and 3.7 mmol / l, respectively.
T max is 1-3 hours.
Distribution

Binding to plasma proteins is high - up to 96-99%.
Penetrates through the placental barrier. With the systematic administration of the drug Ursor ® C, ursodeoxycholic acid becomes the main bile acid in the blood serum and accounts for about 48% of the total amount of bile acids in the blood. The therapeutic effect of the drug depends on the concentration of ursodeoxycholic acid in the bile.
Metabolism and excretion

Metabolised in the liver (clearance at the "primary passage" through the liver) with the formation of taurine and glycine conjugates.
The resulting conjugates are secreted into bile.
About 50-70% of the total dose of the drug is excreted by bile.
A small amount of unsweetened ursodeoxycholic acid enters the large intestine, where it undergoes cleavage by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and is rapidly excreted as a sulfolithocholylglycine or sulfolithocholyltaurine conjugate.
INDICATIONS

- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic therapy);

- Dissolution of small and medium cholesterol stones with a functioning gallbladder;

- Biliary reflux gastritis.

DOSING MODE

Ursor ® C is taken internally.

To dissolve cholesterol gallstones, the average daily dose is 10 mg / kg, which corresponds to: for patients with a body weight of 34-60 kg, 2 caps / day;
with a body weight of 61-81 kg - 3 caps / day; with a body weight of 81-100 kg - 4 caps / day; with a body weight of more than 100 kg - 5 caps. / day. The course of treatment is 6-12 months. For the prevention of repeated formation of stones, it is recommended to take the drug for several months after the dissolution of the stones.
With biliary reflux gastritis, the dose is 250 mg 1 time / day.
The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.
Symptomatic therapy of primary biliary cirrhosis: the average daily dose is 10-15 mg / kg, which corresponds to: for patients with a body weight of 34 to 50 mg - 2 caps / day;
with a body weight of 51-65 kg - 3 caps / day; with a body weight of 66-85 kg - 4 caps / day; with a body weight of 86-110 kg - 5 caps / day; with a body weight of more than 110 kg - 6 caps. / day.
Capsules are taken in the evening, without chewing, with a small amount of water.

SIDE EFFECT

On the part of the digestive system: nausea, vomiting, diarrhea (can be dose-dependent), constipation, transient (transient) increase in hepatic transaminase activity, abdominal pain;
rarely - calcification of gallstones.
Allergic reactions: various manifestations, incl.
hives.
Dermatological reactions: exacerbation of previously existing psoriasis, alopecia.

Other: back pain.

CONTRAINDICATIONS

- X-ray positive (high in calcium) gallstones;

- non-functioning gallbladder;

- a bile-gastric fistula;

- Acute cholecystitis;

- Acute cholangitis;

- cirrhosis of the liver in the stage of decompensation;

- acute infectious diseases of the gallbladder, bile ducts and intestines;

- marked hepatic and / or renal insufficiency;

- Obturation of the bile ducts;

- Empyema of the gallbladder;

- Pregnancy;

- the period of lactation (breastfeeding);

- adults and children weighing up to 34 kg;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated use in severe renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in patients with severe hepatic impairment.

APPLICATION FOR CHILDREN

Contraindicated in children with body weight less than 34 kg.

SPECIAL INSTRUCTIONS

When taking the drug for the purpose of dissolution of gallstones, it is necessary to observe the following conditions: the stones should be cholesterol (x-ray negative), their size should not exceed 15-20 mm, the gallbladder should remain functional and should be filled with stones no more than half, the vesicle and common bile duct should be preserved.

With prolonged (more than 1 month) drug intake, every 4 weeks in the first 3 months of treatment, then - every 3 months to conduct a biochemical blood test to determine the activity of hepatic transaminases.
Control of the effectiveness of treatment should be carried out every 6 months according to ultrasound and radiographic examination of the biliary tract.
After completely dissolving the stones, it is recommended to continue using the drug Ursoron ® C for at least 3 months, in order to facilitate the dissolution of stone remains that are too small for

their detection and for the prevention of recurrence of stone formation.

If within 6 months after the initiation of therapy, partial dissolution of the stones did not occur, it is unlikely that the treatment will be effective.

In the appointment with the purpose of dissolution of gallstones, it is necessary to control the activity of hepatic transaminases and alkaline phosphatase, GGT, bilirubin concentration.
If the increased indices remain, the drug should be discontinued.
If the gallbladder can not be visualized during radiography, with calcification of gallstones, violation of the contractility of the gallbladder, or frequent attacks of biliary colic, treatment should be discontinued.

OVERDOSE

Cases of overdose of ursodeoxycholic acid are not known.

DRUG INTERACTION

Antatsida containing aluminum and ion-exchange resins (colestyramine), reduce the absorption of the drug.

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

Strengthens the effect of oral hypoglycemic drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light, at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
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