Ursodez, capsules 250 mg 50 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. Reduces the lithogenicity of bile, increases the content of bile acids.

Increases gastric and pancreatic secretion, increases lipase activity. It has 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, affects immunological reactions in the liver: decreases the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, interleukin-2 formation, decreases the number of eosinophils.

Indications

dissolution of cholesterol gallstones;

– biliary reflux gastritis;

– primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).

Active ingredient

Composition

Capsules are hard gelatin, size #0, white, opaque;

The contents of the capsules are powder of white or almost white color.

1 capsuleoursodeoxycholic acid250 mg

Auxiliary substances:

Pregelatinized starch (starch 1500) – 73 mg,

Colloidal silica (aerosil) – 5 mg,

Magnesium stearate – 2 mg.

Capsule shell composition:

Titanium dioxide, gelatin.

How to take, the dosage

For dissolution of cholesterol gallstones a dose of 10 mg/kg body weight once daily.

Body weightNumber of capsules up to 60 kg261-80 kg381-100 kg4above 100 kg5

The drug should be taken daily in the evening before bedtime (capsules are not chewed), with small amount of fluid.

The treatment duration is 6-12 months. To prevent recurrent cholelithiasis it is recommended to take the drug for several months after the stones are dissolved.

For treatment of biliary reflux gastritis appoint 1 caps. Ursodez daily in the evening before going to bed with not a lot of water. The course of treatment is from 10-14 days to 6 months, if necessary – up to 2 years.

For symptomatic treatment of primary biliary cirrhosis the daily dose depends on body weight and is from 2 to 6 capsules (about 10-15 mg/kg of body weight).

The following dosing regimen is recommended.

Body weightDaily dose (capsules)morning noon evening 34-50 kg21-151-65 kg311166-85 kg411286-110 kg5122over 110 kg6222

Interaction

Colestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce 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 at least 2 hours before taking Ursodez.

Ursodeoxycholic acid may increase the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the physician should check the blood concentration of cyclosporine and adjust the dose of cyclosporine if necessary.

In some cases Ursodez may reduce absorption of ciprofloxacin.

Hypolipidemic drugs (especially clofibrate), estrogens, neomycin or gestagens increase bile cholesterol saturation and may decrease the ability to dissolve cholesterol bile concretions.

Special Instructions

In cholelithiasis, the effectiveness of treatment is monitored every 6 months by radiological and ultrasound examination of the biliary tract in order to prevent recurrence of cholithiasis.

In cholestatic liver disease, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in serum should be determined periodically.

Influence on driving and operating machinery

There are no data on the effect of ursodeoxycholic acid on the ability to drive vehicles and operate machinery.

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;

– significant impairment of liver function;

– significant impairment of pancreatic function;

– pregnancy;

– period of lactation (breastfeeding);

– adults and children up to 34 kg of body weight;

– hypersensitivity to the components of the drug.

Side effects

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

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

No cases of overdose have been identified.

In case of overdose symptomatic treatment is administered.

Pregnancy use

The drug is contraindicated in pregnancy and during lactation (breastfeeding).

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