Universal reference book for medicines
Product name: URSOMIK ® (URSOMIC)

Active substance: ursodeoxycholic acid

Type: A drug that dissolves cholesterol gallstones

Manufacturer: MINSKINTERKAPS UP (Republic of Belarus)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Hepatoprotector.
Ursodeoxycholic acid is bile acid. Reduces the cholesterol content in the bile, mainly by dispersing cholesterol and forming a liquid-crystalline phase.Influences on enterohepatic circulation of bile salts, reducing reabsorption in the intestine of endogenous more hydrophobic and potentially toxic compounds.
In vitro studies have shown that ursodeoxycholic acid has a direct hepatoprotective effect and reduces the hepatotoxicity of hydrophobic bile salts.

Influences immunological reactions, reducing the pathological expression of Class I HLA antigens on hepatocytes and suppressing the production of cytokines and interleukins.

Ursodeoxycholic acid reduces the lithogenic index of bile, increasing the content of bile acids in it.
Promotes partial or complete dissolution of cholesterol gallstones with oral administration. Has a choleretic effect.
INDICATIONS
Cholesterol gallstones in the gallbladder and common bile duct in patients when surgical or endoscopic treatment can not be performed.
Cholesterol stones of the gallbladder and common bile duct no more than 1.5-2 cm in diameter after extracorporeal lithotripsy or mechanical lithotripsy. Primary biliary cirrhosis (before the formation of advanced fibrosis and cirrhosis of the liver). Chronic active hepatitis with cholestatic syndrome. Acute hepatitis, cystic fibrosis of the liver, congenital atresia of the bile duct. Biliary reflux-esophagitis and gastritis. Biliary dyspeptic syndrome with cholecystopathy and biliary dyskinesia. Prevention and treatment of cholestatic syndrome caused by the intake of hormonal contraceptives. For the normalization of liver function in patients receiving therapy with cytostatics, as well as in patients with alcoholic liver damage. Transplantation of the liver and other organs (auxiliary treatment).
DOSING MODE
Install individually.
Usually used in a dose of up to 10 mg / kg / day. The daily dose is taken once in the evening. The duration of treatment depends on the indications.
SIDE EFFECT
Perhaps: a transient increase in hepatic transaminase activity, skin itching, allergic reactions.

Rarely: diarrhea, calcification of gallstones.

CONTRAINDICATIONS
Acute inflammatory diseases of the gallbladder and bile ducts, cirrhosis of the liver in the stage of vascular and parenchymal decompensation and / or severe activity, NNC, Crohn's disease, severe renal dysfunction, hypersensitivity to ursodeoxycholic acid.

PREGNANCY AND LACTATION
Ursodeoxycholic acid should not be used during pregnancy.

Women of childbearing age during the period of treatment with ursodeoxycholic acid are recommended to use non-hormonal contraceptives or contraceptives with low estrogen content.

It is not known whether ursodeoxycholic acid is excreted in breast milk.

APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal dysfunction.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in cirrhosis of the liver in the stage of vascular and parenchymal decompensation and / or severe activity.

SPECIAL INSTRUCTIONS
For successful litholysis with ursodeoxycholic acid, the following conditions must be met: stones must be pure cholesterol, i.e.
not to give a shadow on the roentgenogram; The size of the stones should not exceed 15-20 mm; the gallbladder must fully retain its function; The gallbladder should be filled with stones no more than half; the permeability of the cystic duct must be preserved; the common bile duct should be free of stones.
When ursodeoxycholic acid is used to dissolve gallstones in the first 3 months of treatment, it is necessary to determine the activity of liver transaminases every 4 weeks.
In the future, these studies can be carried out at intervals of 3 months.
To monitor the effectiveness of treatment, it is recommended to perform X-ray and ultrasound examination of the bile ducts every 6 months.

To prevent the recurrence of cholelithiasis, treatment should continue for several more months after the dissolution of gallstones.

DRUG INTERACTION
With simultaneous use with cyclosporin, absorption improves unpredictably and the concentration of cyclosporin in the blood plasma increases.

A case of a decrease in the concentration of ciprofloxacin in the blood plasma in a patient receiving ursodeoxycholic acid is described.

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