Dissolution of cholesterol gallstones with a diameter not exceeding 15 mm, permeable to X-rays, in patients who, despite the presence of stones, gallbladder function is preserved. Symptomatic treatment of primary biliary cirrhosis of the liver, provided that no decompensated cirrhosis is present.
Composition:
1 capsule contains 150 mg or 300 mg of ursodeoxycholic acid. The product contains azorubine. In addition, capsules of 150 mg contain lactose monohydrate.
Action:
Ursodeoxycholic acid is a natural bile acid found in small amounts in human bile. It reduces the absorption, production and secretion of cholesterol in the bile. Probably due to the scattering of cholesterol and the formation of liquid crystals, gradual dissolution of cholesterol deposits occurs. The action of ursodeoxycholic acid in diseases of the liver and bile ducts consists in replacing lipophilic, detergent-like, toxic bile acids by hydrophilic and nontoxic ursodeoxycholic acid with cytoprotective properties, improving the secretory function of hepatocytes and regulating immunological processes. After oral administration, it is rapidly absorbed in the jejunum and upper ileum (passive transport) and in the distal ileum (active transport). 60-80% of the administered dose is absorbed. Absorbed ursodeoxycholic acid is almost entirely conjugated in the liver with amino acids, Glycine and Taurine, and then secreted into the bile. About 60% of ursodeoxycholic acid is metabolized during the first pass through the liver. Part of the ursodeoxycholic acid is broken down by intestinal bacteria to 7-ketolithiol acid and lithocholic acid. Lithocholic acid is absorbed from the gastrointestinal tract to a very small extent. After absorption, it is detoxified by conjugation with sulfuric acid in the liver, and then it is secreted into the bile and finally excreted in the faeces.
Contraindications:
Hypersensitivity to the components of the preparation. acute inflammation of the gall bladder and bile ducts. Obstruction of the common bile duct or the follicular duct. The presence of calcifications within deposits. Disorders of the gallbladder systolic function. Frequent ascent of biliary colic. The drug should not be used if the gallbladder is invisible on the X-ray.
Precautions:
The functional parameters of the liver should be monitored: AST, ALT, GGT every 4 weeks for the first 3 months, and then every 3 months in the blood serum. After 6-10 months from the start of treatment (depending on the diameter of the deposits), radiological examination of the gall bladder should also be performed (oral cholecystography) - this will facilitate the evaluation of treatment effectiveness and early detection of calcifications within the bile deposit. Radiographs (review and contrast) should be performed both in upright and supine position (ultrasound monitoring). Due to the content of azorubine, the drug may cause allergic reactions. 150 mg contains lactose monohydrate and should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lappa type) or malabsorption of glucose-galactose. Do not use in children.
Pregnancy and lactation:
There are no adequate data on the use of the drug in pregnant women. The preparation should not be used during the first trimester of pregnancy. Before starting treatment, check whether the patient is not pregnant. Women of child-bearing age should take effective anti-pregnancy therapies. There is insufficient data on the ursodeoxycholic acid excretion in milk. It should not be used during breast-feeding.
Side effects:
Common: bright stools, diarrhea. Very rare: calcification of gallstones, urticaria. Very rarely patients with primary biliary cirrhosis experienced severe pain in the right upper abdominal quadrant and worsening of liver disease symptoms, which partially resolved after discontinuation of therapy.
Dosage:
Orally. Adults.Dosage is determined individually for each patient.Cholelithiasis: usually 8-10 mg / kg body weight per day in 2-3 divided doses during meals (eg: for a 75 kg patient the dose is 2 capsules of 150 mg or 1 capsules of 300 mg twice daily). In obese patients, the dose is increased to 15 mg / kg body weight per day. The treatment is long-lasting and usually lasts from 6 months to 2 years, depending on the size and composition of the stones. It is recommended to continue treatment for at least 3 months after radiologically or ultrasonographically confirmed stone dissolution.Primary biliary cirrhosis: typically 13 - 15 mg / kg body weight per day in 2-3 divided doses over 1-2 years (eg: for a 75 kg patient the dose is 7 capsules of 150 mg per day, ie 2 capsules in the morning 2 caps at noon and 3 caps at evening). Capsules containing a higher dose of ursodeoxycholic acid may also be used.Way of giving. The capsules should be taken whole, with meals, with a small amount of liquid.