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 cholesterol stones with a functioning gallbladder;

– biliary reflux gastritis;

– chronic hepatitis of different genesis;

– primary sclerosing cholangitis;

– cystic fibrosis (cystic fibrosis);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Active ingredient

Composition

Interaction

In some cases Ursodez may reduce absorption of ciprofloxacin.

Directions 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 should be taken daily in the evening before going to bed (capsules should not be chewed), with a small amount of liquid.

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

The effectiveness of treatment should be evaluated every 6 months with ultrasound or radiography. In an interim evaluation, it should be assessed whether the stones have calcified since then. If stones have calcified, treatment should be stopped.

Special Instructions

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

In the first 3 months of treatment liver functional parameters (transaminases, ALP and GGT) in serum should be monitored every 4 weeks, and then every 3 months. Monitoring of these parameters allows to detect liver dysfunction at early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, this is a quick way to determine if a patient with primary biliary cirrhosis is responding to ongoing treatment.

Application for dissolution of cholesterol gallstones

In order to evaluate the progress of treatment, as well as for early detection of signs of stone calcification, the gallbladder should be visualized (oral cholecystography) with observation of darkening in standing and supine position (ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on X-rays or in case of calcification of the stones, poor gallbladder contractility or frequent attacks of colic, Ursodez should not be used.

Treatment of patients with advanced stages of primary biliary cirrhosis

There have been extremely rare cases of decompensation of liver cirrhosis. After discontinuation of therapy, regression of decompensation manifestations was noted.

Long therapy with ursodeoxycholic acid in high doses (28-30 mg/kg/day) may cause serious adverse events in patients with primary sclerosing cholangitis.

In patients with diarrhea, the drug dose should be reduced. Treatment should be discontinued in persistent diarrhea.

Influence on driving and operating ability

There is no effect on driving and operating ability.

Contraindications

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

– non-functioning gallbladder;

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

– decompensated cirrhosis of the liver;

– marked renal dysfunction;

– marked impairment of liver function;

– marked impairment of pancreatic function;

– adults and children with a body weight up to 34 kg;

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

– hypersensitivity to the components of the drug.

With caution should the drug be prescribed in patients with cholelithiasis and cholestatic liver diseases.

Side effects

Digestive system disorders: diarrhea, nausea, pain in epigastric region and right subcostal area, calcification of gallstones, increased liver transaminase activity.

In treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may be observed, which disappears after discontinuation of the drug.

Other: allergic reactions.

Overdose

Pregnancy use

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