Ursoliv, capsules 250 mg 50 pcs

Ursoliv has hepatoprotective, choleretic, cholitholytic, hypolipidemic, hypocholesterolemic and some immunomodulatory effects.

In in vitro studies it was shown that ursodeoxycholic acid (UDCA) has direct protective effect on liver cells and reduces hepatotoxicity of hydrophobic salts of bile acids.

The main effects of UDCA on cholesterol metabolism include: reducing cholesterol secretion, reducing intestinal absorption and stimulating the release of cholesterol from cholesterol stones into the bile. UDCA, by inhibiting HMK-CoA reductase, also has a moderate inhibitory effect on cholesterol synthesis in the liver, Increases cholesterol solubility in the biliary system. Causes partial or complete dissolution of cholesterol gallstones when enteral administration, reduces the saturation of bile with cholesterol,

Stimulates the formation and excretion 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 during absorption in the small intestine and also during penetration through the hepatocyte membrane, which leads to a decrease in absorption of toxic bile acids in the intestine and their entry into the liver, preventing their cytopathogenic effect.

Decreases lithogenicity of bile, increases concentration of bile acids in it, causes intensification of gastric and pancreatic secretion, increases lipase activity, has hypoglycemic effect. It affects immunological reactions by decreasing pathological expression of antigens of major histocompatibility complex HLA I on hepatocytes and HLA II on cholangiocytes, inhibits interleukin 2 production, decreases eosinophils number.

Indications

– Primary biliary cirrhosis in the absence of signs of decompensation (symptomatic therapy);
– Dissolution of small and medium-sized cholesterol stones with a functioning gallbladder;
– Biliary reflux gastritis.

Pharmacological effect

Ursoliv has hepatoprotective, choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic 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: reducing cholesterol secretion, reducing intestinal absorption and stimulating the release of cholesterol from cholesterol stones into bile. UDCA, by inhibiting HMC-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 partial or complete dissolution of cholesterol gallstones when administered enterally, reduces the saturation of bile with cholesterol,

Stimulates the formation and secretion of bile, accelerates the elimination of toxic bile acids through the intestines. When taken orally, the proportion of UDCA in the total pool of bile acids increases significantly; UDCA competes with other bile acids during absorption in the small intestine, as well as during penetration through the hepatocyte 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 effect.

Reduces the lithogenicity of bile, increases the concentration of bile acids in it, causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. It influences immunological reactions, reducing the pathological expression of major histocompatibility complex antigens HLA I on hepatocytes and HLA II on cholangiocytes, suppresses the production of interleukin 2, reduces the number of eosinophils

Special instructions

To dissolve gallstones with UDCA, the stones must be cholesterol (not radiopaque) and no larger than 15-20 mm in size. In this case, the gallbladder must remain functional, and the patency of the cystic and common bile ducts must be preserved.

When prescribed for the purpose of dissolving gallstones, it is necessary to conduct a biochemical blood test monthly and then every 3 months to determine the activity of “liver” transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase, as well as bilirubin concentration. If elevated levels persist, the drug should be discontinued.

To monitor the effectiveness of treatment, it is recommended to conduct x-ray and ultrasound examination of the biliary tract every 6 months.
If there is calcification of gallstones, impaired contractility of the gallbladder, or frequent attacks of biliary colic, treatment should be discontinued.

If partial dissolution of the stones has not occurred within 6-12 months after the start of therapy, it is unlikely that the treatment will be effective.

The discovery of a non-visualized gallbladder during treatment is evidence that complete dissolution of the stones has not occurred and treatment should be discontinued.

After complete dissolution of stones, to avoid relapses, it is recommended to continue using ursodeoxycholic acid for 3 months.

The drug does not have a negative effect on the ability to drive vehicles and/or other mechanisms.

Active ingredient

Ursodeoxycholic acid

Composition

1 capsule contains:

Active ingredient:

ursodeoxycholic acid 250 mg.

Excipients:

lactulose,

microcrystalline cellulose,

low molecular weight povidone,

magnesium stearate,

talc

Hard gelatin capsules:

gelatin, titanium dioxide, azorubine dye

Contraindications

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

Side Effects

From the digestive system: nausea, vomiting, pain in the epigastric region and right hypochondrium, constipation, transient increase in the activity of “liver” transaminases; rarely – diarrhea (may be dose-dependent), calcification of gallstones.

When treating primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Other: headache, malaise, myalgia, dizziness, allergic reactions (itching, urticaria, angioedema), exacerbation of pre-existing psoriasis, alopecia.

Interaction

When used together, antacids containing aluminum and ion exchange resins (cholestyramine) reduce the absorption of UDCA.

When used concomitantly, lipid-lowering drugs (especially clofibrate), estrogens, neomycin or progestogens (oral contraceptives) increase the saturation of bile with cholesterol and may reduce the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.

When used concomitantly, UDCA may increase the absorption of cyclosporine.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf life

4 years.

Manufacturer

ABVA RUS, Russia