Ursosan®
hard capsules
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Acidum ursodeoxycholicum 250 mg in 1 capsule.
- Indication group:
- hepatic agent, dissolvent of cholesterol gallstones
The following information is for health professionals only.
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Characteristics:
Ursodeoxycholic acid (UDCA) is a bile acid which naturally occurs in human bile. In comparison with other bile acids, it is virtually non-toxic. After oral administration, UDCA is transported to the liver and its increased concentration in a mixture of bile acids results both in a decrease in the saturation of bile with cholesterol, and in increased solubility of cholesterol on the surface of concretions which have already developed. UDCA regulates symptomatology and pathological laboratory, immunological and also some histological changes accompanying primary biliary cirrhosis and a number of other liver diseases, particularly if they are connected with intrahepatic cholestasis.
Indications:
Dissolution of uncalcified cholesterol gallstones (up to a size of 15 mm) while retaining the function of the gall bladder.
Dissolution of the debris of these stones after lithotripsy.
Cholestatic syndrome in primary biliary cirrhosis, sclerotizing cholangitis, hepatitides of different etiology, and other conditions of intrahepatic cholestasis.
Reactive gastritis after duodenogastritic reflux.
Contraindications:
Hypersensitivity to Ursodeoxycholic acid and supplemental substances.
Acute cholecystitis and cholangitis.
Liver cirrhosis in an advanced stage.
Serious disorders of liver or renal functions.
1st trimester of pregnancy. Children before 2 years of age.
Undesirable effects:
Diarrhoea, pruritus, allergic skin rashes.
Interactions:
Cholestyramine, colestipole and antacids can lower absorption of Ursodeoxycholic acid.
Caution:
Liver enzymes need to be monitored during treatment: every four weeks during the first three months, later once every quarter. When administering the Ursodeoxycholic acid (UDCA) in 2nd and 3rd trimester of pregnancy, treatment benefits must be evaluated in view of risks for a fetus. Administering UDCA during lactation must be considered by a specialist.
Dosage:
Daily dose of Ursosan® caps. used to dissolve gallstones depends on the body weight of the patient. Usually it is 10 mg/kg/day, i.e. 2 to 5 capsules a day. The total daily dose of Ursosan® caps. is administered as a single dose in the evening. Administration of Ursosan® caps. as a preparation for dissolution of gallstones is a long-term one (0.5-2 years). Efficacy of the treatment is checked ultrasonographically once every six months. Dosing in case of cholestatic syndromes is individual and should not exceed 6 capsules a day divided into 2-3 doses. Length of treatment is based on the character and clinical development of the disease. Capsules are swallowed whole and washed down with a sufficient volume of a liquid.
Package:
50 or 100 hard capsules.
Complete information about the preparation is included in the drug information sheet.
Date of the last revision: January 14, 2009.
The preparation is available on medical prescription only and is paid for by public medical insurance.