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. Primary biliary cirrhosis in the early stages of the disease. Gastritis due to bile deposition. [Hepatobiliary disorders associated with cystic fibrosis in children and adolescents from 6 to 18 years of age]
Composition:
One capsule contains 250 mg of ursodeoxycholic acid.
Action:
Ursodeoxycholic acid is a hydrophilic bile acid naturally occurring in the body. It reduces the volume of bile and its saturation with cholesterol, which is the result of reducing the secretion of cholesterol to bile. It probably also reduces the intestinal absorption of cholesterol and reduces cholesterol synthesis. The direct protective effect on the liver consists in blocking the bile acid receptors on the hapatocyte membrane or on stabilizing this membrane due to the direct absorption of ursodeoxycholic acid. After oral administration, it is rapidly absorbed, mainly in the jejunum and proximal ileum, and undergoes extensive metabolism in the liver. It binds with glycerine and Taurine and is excreted from the liver with bile. The maximum concentration occurs after 30-60 min.
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. Frequent episodes of biliary colic. Calcified gallstones visible in X-rays. Weakened gallbladder contractility. Do not use after unsuccessful portoenterostomy or lack of improvement in bile flow in children with biliary obstruction. Do not use in children under 2 years.
Precautions:
Pregnancy and lactation:
Due to the lack of clinical trials, in women of childbearing age, the preparation can be used only when combined with contraception. Non-hormonal methods are recommended. Pregnancy must be ruled out before starting treatment. Do not use during breast-feeding.
Side effects:
Clear stools or diarrhea have frequently been reported in clinical trials (diarrhea should be reduced if diarrhea occurs, and treatment should be discontinued if persistent diarrhea occurs). Very rare: calcification of gallstones; hives; during treatment of severe primary biliary cirrhosis - severe pain in the right abdominal square and worsening of symptoms of liver cirrhosis, which partially resolved after discontinuation of the drug.
Dosage:
Orally. Adults:when dissolving cholesterol gallstones 10 mg / kg / m.c. (2-5 capsules) per day in 1 dose, use in the evening before bedtime. The following dosage schedule is recommended: people with a m.c. up to 60 kg - 500 mg per day (2 capsules), people with a m.c. 60-80 kg - 750 mg per day (3 capsules), people with a m.c. 80-100 kg - 1000 mg per day (4 capsules), people with m.c. over 100 kg - 1250 mg per day (5 capsules). The duration of treatment is 0.5-2 years. After dissolving stones, it is recommended to continue treatment for 3 months to completely dissolve the deposits.INinflammation of the mucous membrane caused by the bile being treated: 1 capsule a day, use at bedtime for 10-14 days.In primary biliary cirrhosis in the early stages of the disease13-15 mg / kg m.c. daily in 2-3 doses. When the functional parameters of the liver improve, the daily dose may be taken once a day in the evening. In children over 2 years, the dose is adjusted individually, the recommended dose is 10-20 mg / kg m.c. per day.Children and adolescents aged 6 to 18 with cystic fibrosis:20 mg / kg daily in 2-3 divided doses. If necessary, the dose can be increased up to 30 mg / kg. per day. The capsule should be eaten without chewing, with water.