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 decompensation signs (symptomatic therapy);
– Dissolution of small and medium cholesterol stones with functioning gallbladder;
– Biliary reflux gastritis.

Active ingredient

Composition

1 capsule contains:

Active substance:

ursodeoxycholic acid 250 mg.

Auxiliary substances:

Lactulose,

Microcrystalline cellulose,

How to take, the dosage

The drug is prescribed orally.

If cholesterol gallstones are dissolved, the capsules are taken in the evening, before going to bed, without chewing and with a small amount of liquid.

Dose of 10 mg/kg of body weight daily, which corresponds to: 2 capsules of Ursolive in patients with body weight less than 60 kg; 3 capsules in patients with body weight less than 80 kg; 4 capsules in patients with body weight less than 100 kg; 5 capsules in patients with body weight over 100 kg.

The duration of treatment is 6-12 months.

In order to prevent recurrent stone formation it is recommended to take the drug for several more months after the stones have dissolved.

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

The drug is taken with food with plenty of water.

For treatment of biliary reflux gastritis it is prescribed 1 capsule 1 time / day before going to bed. The course of treatment is from 10-14 days to 6 months, if necessary – up to 2 years.

Interaction

When co-administered, antacids containing aluminum and ion exchange resins (colestyramine) reduce absorption of UDCA.

In concomitant use, hypolipidemic drugs (especially clofibrate), estrogens, neomycin or progestogens (oral contraceptives) increase bile cholesterol saturation and may decrease the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.

Concomitant use of UDCA may increase absorption of cyclosporine.

Special Instructions

To dissolve UDCA gallstones, the concrements must be cholesterol-containing (not X-ray-contrasting), not more than 15-20 mm in size. At the same time the gallbladder must remain functional, and patency of the vesicular and common bile ducts must be preserved.

If the drug is prescribed to dissolve gallstones, it is necessary to carry out monthly and then – once in 3 months – biochemical blood tests to determine the activity of liver transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase, and bilirubin concentration. If elevated values persist, the drug should be discontinued.

In order to control treatment effectiveness it is recommended to take biliary tract X-ray and ultrasound investigation every 6 months.
If gallstones calcification, gallbladder contractility disorders or frequent biliary colic attacks occur, the treatment should be discontinued.

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

Detection of an invisible gallbladder during treatment is an indication that complete dissolution of the concrements has not occurred, and treatment should be discontinued.

After complete dissolution of the stones, to exclude recurrence, it is recommended to continue the use of ursodeoxycholic acid, for 3 months.

The drug has no adverse effect on the ability to drive vehicles, and/or other mechanisms.

Contraindications

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

Side effects

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

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

Others: headache, malaise, myalgia, dizziness, allergic reactions (skin itching, urticaria, angioedema), exacerbation of previous psoriasis, alopecia.

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