Ursoliv capsules 250mg №50

Capsules

Composition

1 capsule contains: ursodeoxycholic acid 250 mg.
Excipients: lactulose, microcrystalline cellulose, low molecular weight povidone, Magnesium stearate, talc.
Hard gelatin capsules: gelatin, titanium dioxide, dye azorubine.

Packaging

In the package 50 pcs.

Mechanism of action

Ursoliv has hepatoprotective, choleretic, cholelitholytic, hypolipidemic, cholesterol-lowering and some immunomodulatory effects.
In vitro studies have shown that ursodeoxycholic acid (UDCA) has a direct protective effect on liver cells and reduces the hepatotoxicity of hydrophobic bile salts.
The main effects of UDCA on cholesterol metabolism include: a decrease in cholesterol secretion, a decrease in its intestinal absorption, and the stimulation of cholesterol from cholesterol stones in bile. UDCA, inhibiting the MMC-CoA reductase, also has a moderate inhibitory effect on cholesterol synthesis in the liver. It increases the solubility of cholesterol in the biliary system. Causes the partial or complete dissolution of cholesterol gallstones during enteral use, reduces the saturation of bile with cholesterol,
Stimulates the formation and secretion of bile, accelerates the excretion of toxic bile acids through the intestine. When taken orally, the proportion of UDCA in the total pool of bile acids increases significantly; UDCA competes with other bile acids in the process of absorption in the small intestine, as well as penetration of the hepatocyte through the membrane, which leads to a decrease in the absorption of toxic bile acids in the intestine and their entry into the liver, preventing their cytopathogenic action. It reduces the lithogenicity of bile, increases the concentration of bile acids in it, causes an increase in gastric and pancreatic secretion, enhances the activity of lipase, and has a hypoglycemic effect. It has an effect on immunological reactions, reducing the pathological expression of antigens of the main histocompatibility complex HLA І on hepatocytes and HLA II on cholangiocytes, suppresses the production of interleukin 2, reduces the number of eosinophils

Indications and usage

- 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.

Contraindications

- The size of cholesterol stones in the gall bladder is more than 20 mm. The presence of radiopaque (high calcium) stones of the gallbladder and common bile duct.
- Atrophy of the gallbladder with cholelithiasis, non-functioning gallbladder. Obstruction of the biliary tract.Acute inflammatory diseases of the gallbladder, bile ducts and intestines.
- Cirrhosis of the liver in the stage of decompensation.
- Severe hepatic and renal failure.
- Pancreatitis (active phase).
- Hypersensitivity to the drug.
- Pregnancy, lactation.
- Adults and children weighing up to 34 kg (for this dosage form)

Pregnancy and Breastfeeding

Contraindicated.

Dosage and administration

The drug is prescribed inside.
When cholesterol gallstones dissolve, capsules are taken in the evening, before going to bed, without chewing and washing down with a small amount of liquid.
A dose of 10 mg / kg body weight daily, which corresponds to: 2 capsules of the drug Ursoliv in patients with body weight up to 60 kg; 3 capsules - in patients with body weight up to 80 kg; 4 capsules - in patients with body weight up to 100 kg; 5 capsules - in patients with a body weight over 100 kg. The duration of treatment is 6-12 months.
To prevent re-formation of stones, it is recommended to take the drug for several months after the stones have dissolved.
In the symptomatic treatment of primary biliary cirrhosis, the daily dose depends on body weight and ranges from 2 to 6 capsules (10 to 15 mg / kg body weight).
The drug is taken with food, drinking plenty of water.
For the treatment of biliary reflux gastritis prescribed 1 capsule 1 time / day before bedtime. The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.

Special notes

To dissolve gallstones, UDCA calculus must be cholesterol (not radiopaque), no larger than 15–20 mm. At the same time, the gallbladder must remain functional, and the permeability of the cystic and common bile ducts must be maintained.
When administered with the purpose of dissolving gallstones, it is necessary monthly, and then every 3 months. perform a biochemical blood test to determine the activity of “liver” transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase, as well as the concentration of bilirubin. If you maintain high levels of the drug should be canceled.
To control the effectiveness of treatment is recommended every 6 months. to carry out X-ray and ultrasound examination of the biliary tract.
When calcification of gallstones, a violation of the contractility of the gallbladder, or frequent bouts of biliary colic, treatment should be stopped. If within 6–12 months after the start of therapy, partial dissolution of the stones did not occur, it is unlikely that the treatment will be effective. Detection of a non-visualized gallbladder during treatment is evidence that the calculus did not completely dissolve, and treatment should be stopped.
After complete dissolution of the stones, to exclude relapses, it is recommended to continue the use of ursodeoxycholic acid, for 3 months.

The drug does not adversely affect the ability to drive vehicles and / or other mechanisms.

Drug Interactions

When used together, antacids containing aluminum and ion exchange resins (Kolestiramine) reduce the absorption of UDCA.
With simultaneous use, lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestogens (oral contraceptives) increase bile cholesterol saturation and can reduce the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.
With the simultaneous use of UDCA can increase the absorption of cyclosporine.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25oC.