Ursoliv
Ursoliv: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Drug interactions
- 10. Analogs
- 11. Terms and conditions of storage
- 12. Terms of dispensing from pharmacies
- 13. Reviews
- 14. Price in pharmacies
Latin name: Ursoliv
ATX code: A05AA02
Active ingredient: Ursodeoxycholic acid (Acidum ursodeoxycholicum)
Producer: JSC "Avva Rus" (Russia)
Description and photo update: 2018-23-10
Prices in pharmacies: from 188 rubles.
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Ursoliv is a hepatoprotective drug.
Release form and composition
Dosage form Ursoliv - capsules: gelatinous solid, size No. 00, white body, pink cap; inside contains white or almost white granular powder (10 pcs. in a cell pack made of PVC film and printed varnished aluminum foil, 1–3, 5 or 10 packs in a cardboard box; 100, 50, 30, 20, 10 pcs. in polymer cans or in plastic bottles with screw caps, 1 can or bottle in a cardboard box).
Composition of 1 capsule:
- active substance: ursodeoxycholic acid (UDCA) - 250 mg;
- auxiliary components: lactulose, low molecular weight povidone K17, magnesium stearate, talc, microcrystalline cellulose;
- capsule: gelatin, titanium dioxide, azorubin dye.
Pharmacological properties
Pharmacodynamics
Ursoliv is a hepatoprotective, choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic drug with some immunomodulatory properties.
UDCA has a direct protective effect on liver cells, and also reduces the hepatotoxicity of hydrophobic bile salts. In addition, ursodeoxycholic acid lowers the secretion of cholesterol, reduces its intestinal absorption and stimulates the release of cholesterol stones into bile, moderately inhibits cholesterol synthesis in the liver, inhibiting MMC-CoA reductase, and also increases its solubility in the biliary system. The use of Ursoliv leads to a partial or complete dissolution of cholesterol gallstones, reduces the concentration of cholesterol in bile. UDCA stimulates the formation and elimination of bile, thereby accelerating the elimination of toxic bile acids through the intestines. During penetration through the hepatocyte membrane, as well as in the process of absorption in the small intestine, UDCA competes with other bile acids,leading to a decrease in the absorption of toxic bile acids in the intestine and their entry into the liver, preventing their cytopathogenic effect.
Ursoliv enhances gastric and pancreatic secretion, lipase activity, reduces the lithogenicity of bile, increasing the concentration of bile acids in it, and has hypoglycemic properties.
Affects immunological reactions, reducing the pathological expression of antigens of the main histocompatibility complex HLA I on hepatocytes and HLA II on cholangiocytes, inhibits the production of interleukin-2, and reduces the number of eosinophils.
Pharmacokinetics
UDCA is absorbed mainly (90%) in the small intestine. The maximum concentration (C max) when ingested 250 mg of the drug is 3.3 μg / ml, is achieved in about 2 hours.
Plasma protein binding - 70%. UDCA crosses the placental barrier. With regular intake of Ursoliv at doses of 13-15 mg / kg / day, UDCA becomes the main bile acid in the serum and accounts for 30-50% of the total bile acid content in the blood. The therapeutic effect of the drug depends on the concentration 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 accepted dose of UDCA is excreted in the bile, 1% in the urine. An insignificant amount enters the colon, is broken down by bacteria, resulting in the formation of lithocholic acid, which is partially absorbed from the colon, sulfated in the liver and excreted within a short period of time in the form of a sulfolitocholylglycine or sulfolitocholyltaurine 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;
- atrophy of the gallbladder, dysfunctional gallbladder, obstruction of the biliary tract;
- 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 of 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.
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 (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-resolves 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).
special instructions
When using Ursoliv to dissolve gallstones, it is advisable to monthly, and then once every 3 months, conduct a biochemical blood test in order to determine the activity of hepatic transaminases, gamma-glutamyl transpeptidase, alkaline phosphatase, and bilirubin concentration. In the case of increased indicators, the drug should be canceled.
To control the results of therapy, ultrasound and X-ray examination of the biliary tract should be carried out once every 6 months. If the calculi did not partially dissolve within 0.5–1 year, it is unlikely that further treatment will be effective.
Treatment should be interrupted in case of calcification of stones, frequent attacks of biliary colic, violations of the contractility of the gallbladder.
After complete dissolution of calculi, therapy is recommended to continue for another 3 months in order to exclude relapses.
Influence on the ability to drive vehicles and complex mechanisms
According to the instructions, Ursoliv does not reduce the ability to concentrate, as well as the speed of psychomotor reactions.
Drug interactions
UDCA, when taken together with cyclosporine, increases its absorption.
Aluminum-containing antacids and ion-exchange resins (colestyramine) reduce the absorption of UDCA.
With complex therapy with lipid-lowering drugs (especially clofibrate), estrogens, neomycin, progesterones (oral contraceptives), the saturation of bile with cholesterol increases, and the property of UDCA to dissolve cholesterol stones may decrease.
Analogs
Ursoliv's analogues are: Pms-Ursodiol, Ukrliv, Ursodex, Ursolak, Ursolizin, Ursomax, Ursonost, Ursosan, Ursofalk, Ursokhol, Choludexan, Exhol, Livodexa.
Terms and conditions of storage
Store in a dry place, away from sunlight, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ursoliv
Reviews about Ursoliv are mostly positive. Patients note the effectiveness of the drug in restoring and maintaining health. However, its high cost is also distinguished.
Price for Ursoliv in pharmacies
The approximate price for Ursoliv is 810 rubles. per package containing 50 capsules.
Ursoliv: prices in online pharmacies
Drug name Price Pharmacy |
Ursoliv 250 mg capsules 10 pcs. 188 r Buy |
Ursoliv 250 mg capsule 50 pcs. 715 RUB Buy |
Ursoliv 250 mg capsule 100 pcs. RUB 1100 Buy |
Ursoliv caps. 250mg No. 100 1775 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!