Release configuration and composition:
Medicinal configuration of Ursoliv - capsules: gelatinous decisive, size No. 00, snow-white body, rainbow cap; inside there is a snow-white or almost snow-white granular powder (10 pcs. in a cell package made of PVC film and printed lacquer aluminum foil, 1-3, 5 or 10 packages in a cardboard stack; 100, 50, 30, 20, 10 pcs. in polymer cans or in plastic bottles with screw caps, 1 can or bottle in a cardboard stack).
Composition:
1 capsule: active substance: ursodeoxycholic acid (UDCA) - 250 mg; auxiliary components: lactulose, low molecular weight povidone K17, magnesium stearate, talc, microcrystalline cellulose; capsule: gelatin, giant dioxide, azorubin dye.
Pharmacological properties:
Pharmacodynamics Ursoliv is a hepatoprotective, choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic drug with individual immunomodulatory properties. UDCA exhibits a genuine protective effect on the liver chambers, and also reduces the hepatotoxicity of hydrophobic salts of pungent acids.
In addition, ursodeoxycholic acid reduces the secretion of cholesterol, reduces its intestinal absorption and stimulates the release of cholesterol stones into bile, softened the synthesis of cholesterol in the liver, slowing down the MMC-CoA reductase, and also enhances its solubility in the biliary system.
The use of Ursoliv leads to partial or deep opening of cholesterol stinging stones, reduces the accumulation of cholesterol in the bile. UDCA stimulates the process of creating and excreting bile, bringing the multitude closer to the excretion of toxic stinging acids through the intestines. When penetrating through the hepatocyte membrane, as well as in the process of absorption in a high hose, UDCA competes with other pungent acids, causing a decrease in the absorption of toxic pungent acids in the intestine and their device in the liver, preventing their cytopathogenic effect.
Ursoliv increases gastric and pancreatic secretion, lipase energy, reduces the lithogenicity of bile, increasing the accumulation of stinging acids in it, has hypoglycemic properties. Affects immunological reactions, reducing the abnormal 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.
Pharmacokinetics:
UDCA absorption occurs primarily (90%) in the intestine. The largest accumulation (Cmax) when 250 mg of the drug is taken internally is 3.3 μg / ml, it can be heard in about 2 hours. Plasma protein binding is 70%. UDCA sneaks through the placental barrier. With the systematic enrollment of Ursoliv in doses of 13-15 mg / kg / day, UDCA stops the main stinging acid in the serum and collects from 30 to 50% of the public content of stinging acids in the blood. The therapeutic effect of the drug depends on the accumulation of UDCA in the bile. It is metabolized in the liver to form taurine and glycine conjugates, secreted into bile. From 50 to 70% of the consumed dose of UDCA is transferred with bile, 1% with urine. A small number is found in the low hose, broken down by microbes, in the fetus of which lithocholic acid is created, some is partially absorbed from the low hose, sulfated in the liver and transferred to the direction of the close interval of the pore in the form of a sulfolitocholylglycine or sulfolitocholyltauric conjugate.
Indications for use:
dissolution of small and medium cholesterol stones with a functioning gallbladder; symptomatic therapy for primary biliary cirrhosis (without signs of decompensation); chronic hepatitis of various etiologies; primary sclerosing cholangitis; biliary reflux gastritis; cystic fibrosis (cystic fibrosis); alcoholic liver disease; non-alcoholic steatohepatitis; biliary dyskinesia.
Contraindications:
the size of stones in the gallbladder is more than 20 mm; the presence of radiopaque stones of the gallbladder and common bile duct; gallbladder atrophy, dysfunctional gallbladder, biliary obstruction; acute inflammatory lesions of the gallbladder, bile ducts and intestines; liver cirrhosis in the stage of decompensation; hepatic and renal failure in a severe stage; active phase of pancreatitis; increased sensitivity to any component of Ursoliv; pregnancy and lactation; body weight ˂ 34 kg.
Instructions for use:
Ursoliv: method and dosage Ursoliv is taken orally with a sufficient amount of liquid. In cases where it is difficult for the patient to swallow the capsule, you can open it and take the contents. The recommended dosage of Ursoliv: dissolution of cholesterol gallstones: 10 mg / kg / day, that is, with a body weight of up to 60 kg - 2 capsules, with a body weight of 60–80 kg - 3 capsules, with a body weight of 80–100 kg - 4 capsules, with a body weight of ˃ 100 kg - 5 capsules. Capsules should be taken in the evening before bedtime. The duration of the course is 6–12 months. In order to prevent relapses, it is recommended to continue taking the drug for several months after the stones dissolve; symptomatic treatment of primary biliary cirrhosis: 10-15 mg / kg / day, that is, with a body weight of 34-50 kg - 2 capsules per day (1 capsule in the morning and in the evening), with a body weight of 51-65 kg - 3 capsules per day (1 capsule in the morning, afternoon and evening), with a body weight of 66–85 kg - 4 capsules per day (1 capsule in the morning and afternoon and 2 capsules in the evening), with a body weight of 86–110 kg - 5 capsules per day (by 1 capsule in the morning and 2 capsules in the afternoon and evening), with a body weight of 110 kg - 6 capsules per day (2 capsules in the morning, afternoon and evening); biliary reflux gastritis: 1 capsule per day, before bedtime. The duration of the course is from 10 days to 6 months, if necessary, the therapy is extended to 2 years; chronic hepatitis of various etiologies, alcoholic liver disease, non-alcoholic fatty liver disease: 10-15 mg / kg / day, divided into 2-3 doses. Course duration - 0.5–1 year; primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis): 12-15 mg / kg / day, if necessary, the dose can be increased to 20-30 mg / kg / day, the daily dose is divided into 2-3 doses. The duration of the course is from 0.5 to several years; hypokinetic biliary dyskinesia: 10 mg / kg / day, divided into 2 doses. The duration of the course is from 2 to 8 weeks, if necessary, the course should be repeated.
Side effects:
digestive system: nausea, vomiting, pain in the epigastric region and right hypochondrium, constipation, transient increase in the activity of hepatic transaminases, calcification of gallstones, diarrhea; other undesirable effects: malaise, myalgia, headache, dizziness, allergic reactions (itching, urticaria, angioedema). When taking Ursoliv for the treatment of biliary cirrhosis, transient decompensation of liver cirrhosis is possible, which self-passes after discontinuation of the drug.
Overdose:
Diarrhea is a symptom of an overdose of Ursoliv. Therapy: reducing the dose of the drug, symptomatic treatment aimed at eliminating dehydration (drinking plenty of fluids, in case of severe dehydration - intravenous drip of fluid)
