Universal reference book for medicines
Product name: URSODEX (URSODEX)

Active substance: ursodeoxycholic acid

Type: Hepatoprotector with choleretic and cholelitholytic action

Manufacturer: Sun Pharmaceutical Industries (India)
Composition, form of production and packaging
Tablets covered with a film coat of brownish-red color, round, biconvex, with a risk on one side; on the break - the core of white color.
1 tab.
ursodeoxycholic acid 150 mg
Additives: lactose 43.5 mg, starch 9 mg, cellulose microcrystalline 22 mg, sodium carboxymethyl starch 13 mg, sodium lauryl sulfate 3 mg, magnesium stearate 3 mg, silicon colloidal dioxide 1.5 mg, talc purified 6.4 mg, Povidone K-30 - 10 mg.
The composition of the film shell: hypersensitivity E5 - 4.8 mg, macrogol-6000 - 0.95 mg, titanium dioxide - 0.48 mg, iron oxide yellow - 0.08 mg, iron oxide red - 0.09 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
Tablets covered with a film coat of brownish-red color, round, biconvex, with a risk on one side; on the break - the core of white color.
1 tab.
ursodeoxycholic acid 300 mg
Auxiliary substances: lactose 87 mg, starch 18 mg, microcrystalline cellulose 44 mg, sodium carboxymethyl starch 26 mg, sodium lauryl sulfate 6 mg, magnesium stearate 6 mg, silicon colloidal dioxide 3 mg, talc purified 20 mg, Povidone K-30 - 10 mg.
The composition of the film shell: hypersensitivity E5 - 9.6 mg, macrogol-6000 - 1.9 mg, titanium dioxide - 0.96 mg, iron oxide yellow - 0.16 mg, iron oxide red - 0.18 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Hepatoprotector. It also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and immunomodulatory effects. Stabilizes membranes of hepatocytes and cholangiocytes, has a direct cytoprotective effect. As a result of the drug on the gastrointestinal circulation of bile acids, the content of hydrophobic (potentially toxic) acids decreases. By reducing the absorption of cholesterol in the intestine and other biochemical effects has a hypocholesterolemic effect. Suppresses cell death due to toxic bile acids.
Possessing high polar properties, ursodeoxycholic acid forms non-toxic 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, stabilize them and render them immune to the action of cytotoxic micelles. 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 (a consequence of the change in the ratio of cholesterol / bile acids to bile) and the prevention of the formation of new concrements (the result of a decrease in the content of bile cholesterol). It induces choleresis, rich in bicarbonates, which leads to an increase in bile passage and stimulates the excretion of toxic bile acids through the intestine.
The immunomodulatory effect is due to inhibition of the expression of HLA antigens (HLA - human leucocyte antigens) on the membranes of hepatocytes and cholangiocytes, normalization of the natural killer activity of lymphocytes. Reliably restrains 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 and distribution
Ursodeoxycholic acid is absorbed from the jejunum by passive diffusion, and from the ileum through active transport. Concentration in the plasma with ingestion of 500 mg is achieved after 30, 60, 90 min - 3.8 mmol / l, 5.5 mmol / l, 3.7 mmol / l, respectively.
The distribution of ursodeoxycholic acid characterizes a high degree of binding to plasma proteins, which can be 96-99%. Penetrates through the placental barrier.
Metabolism and excretion
As a result of presystemic elimination of ursodeoxycholic acid, taurine and glycine conjugates are formed, which are secreted into bile. About 50-70% of the entire administered dose of ursodeoxycholic acid is excreted with bile.
The rest of the unsweetened fraction of ursodeoxycholic acid enters the large intestine, where it undergoes bacterial cleavage (7-dehydroxylation) to form lithocholic acid. Litocholic acid is partially absorbed from the intestine, biotransformed in the liver into sulfolithocholylglycine and sulfolitocholyltaurine conjugates and is excreted.
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
Tablets are taken orally, in the evening, without liquid, squeezed with a small amount of water.
To dissolve cholesterol gallstones, the average daily dose of Ursodex is 10 mg / kg. 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.
Patients with a body weight of less than 34 kg are recommended to take the drug in the form of a suspension.
SIDE EFFECT
From the digestive system: calcification of gallstones, increased activity of hepatic transaminases, diarrhea, nausea, abdominal pain; in the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis that occurs after the drug cancellation can be observed.
Other: allergic reactions (including urticaria).
CONTRAINDICATIONS
- X-ray positive (high in calcium) gallstones;
- non-functioning gallbladder;
- acute inflammatory diseases of the gallbladder, bile ducts and intestines;
- cirrhosis of the liver in the stage of decompensation;
- marked hepatic and / or renal insufficiency;
- pancreatitis;
- lactose intolerance, lactase deficiency or malabsorption of glucose-galactose;
- Pregnancy;
- lactation period;
- adults and children with a body weight of up to 34 kg (for this dosage form);
- increased individual sensitivity to the components of the drug.
PREGNANCY AND LACTATION
When pregnancy, the use of Ursodex is contraindicated. If it is necessary to prescribe the drug during lactation, breastfeeding should be abandoned.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindication: severe renal failure

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindication: severe hepatic impairment, liver cirrhosis.
APPLICATION FOR CHILDREN
Contraindications: children with body weight up to 34 kg (for this dosage form);
SPECIAL INSTRUCTIONS
To successfully dissolve it is necessary that the stones are pure cholesterol, not more than 15-20 mm in size, the gallbladder is filled with stones no more than half and the bile ducts fully retained their function.
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.
Cholecystography should be performed every 4 weeks in the first 3 months of treatment, then every 3 months. Control of treatment effectiveness should be performed every 6 months during ultrasound during the first year of therapy. After complete dissolution of the calculus, it is recommended to continue use for at least 3 months, in order to promote the dissolution of stone residues, the dimensions of which are too small for their detection.
If within 6-12 months after the beginning of therapy of partial dissolution of concrements did not occur, it is unlikely that the treatment will be effective.
Detection during treatment of a nonvisualizable gallbladder is evidence that no complete dissolution of the calculi has occurred, and treatment should be discontinued.
When calcification of gallstones, violation of the contractility of the gallbladder or frequent attacks of biliary colic, treatment should be discontinued.
Impact on the ability to drive vehicles and manage mechanisms
There is no evidence of the influence of ursodeoxycholic acid on the ability to drive vehicles and work with mechanisms.
OVERDOSE
Cases of overdose of ursodeoxycholic acid are not known.
DRUG INTERACTION
Do not use the drug simultaneously with antacids containing aluminum and ion exchange resins, because these drugs can disrupt the absorption of ursodeoxycholic acid.
When used simultaneously, lipid-lowering medications, estrogens, neomycin or gestagens (oral contraceptives) increase bile saturation with cholesterol and may reduce the ability of ursodeoxycholic acid to dissolve cholesterol bile stones.
Ursodex can increase the absorption of cyclosporine from the intestine, which requires monitoring the concentration of cyclosporine in the blood, and, if necessary, correcting its dosage regimen.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C. Shelf life - 2 years.
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