Ursolive capsules 250mg, 50pcs

Composition

1 capsule contains:  

Active ingredient:

ursodeoxycholic acid 250 mg.

Auxiliary substances:

Ingredients: lactulose,

microcrystalline cellulose,

low-molecular-weight povidone,

magnesium stearate,

talc. Hard gelatin capsules:

gelatin, titanium dioxide, dye azorubin

Pharmacological action

Ursoliv has hepatoprotective, choleretic, cholelitolytic, 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: reduced cholesterol secretion, reduced intestinal absorption, and stimulation of cholesterol release from cholesterol stones to bile. UDCA, inhibiting MMC-CoA reductase, also has a moderate suppressive effect on the synthesis of cholesterol in the liver, increases the solubility of cholesterol in the biliary system. Causes partial or complete dissolution of cholesterol gallstones with enteral application, reduces the saturation of bile with cholesterol,

It stimulates the formation and excretion 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 in the process of absorption in the small intestine, as well as when penetrating 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, increases the activity of lipase, and has a hypoglycemic effect. It has an effect on immunological reactions, reduces the pathological expression of antigens of the main histocompatibility complex HLA I on hepatocytes and HLA II on cholangiocytes, suppresses the production of interleukin 2, reduces the number of eosinophils

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.

Contraindications

-The size of cholesterol stones in the gallbladder is more than 20 mm. The presence of radiopaque (high-calcium) gallbladder and common bile duct stones. – Gallbladder atrophy in 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 insufficiency. – 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” hepatic ” transaminases; rarely – diarrhea (may be dose-dependent), calcification of gallstones.

In the treatment of primary biliary cirrhosis, temporary decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

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

Interaction

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

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

When used concomitantly, UDCA may increase cyclosporine absorption.

How to take, course of use and dosage

The drug is prescribed inside.

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

The dose is 10 mg / kg of body weight daily, which corresponds to: 2 capsules of Ursoliv in patients with a body weight of up to 60 kg; 3 capsules – in patients with a body weight of up to 80 kg; 4 capsules – in patients with a body weight of up to 100 kg; 5 capsules – in patients with a body weight of over 100 kg.

The duration of treatment is 6-12 months.

To prevent the re-formation of stones, it is recommended to take the drug for several more months after the dissolution of the stones.

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

The drug is taken with food, washed down with a sufficient amount of water.

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

Special instructions

For the dissolution of UDCA gallstones, concretions should be cholesterol (not radiopaque), no more than 15-20 mm in size. At the same time, the gallbladder should remain functional, and the patency of the cystic and common bile ducts should 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-glutamyltranspeptidase, as well as bilirubin concentration. If elevated indicators persist, the drug should be discontinued.

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

If there is no partial dissolution of the calculus within 6-12 months after the start of therapy, it is unlikely that the treatment will be effective.

Detection of an unvisualized gallbladder during treatment is an indication that the calculus has not completely dissolved and treatment should be discontinued.

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

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

Form of production

Capsules

Storage conditions

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

Shelf

life is 4 years.

Active ingredient

Ursodeoxycholic acid

Conditions of release from pharmacies

By prescription

Dosage form

Capsules