Ursoliv/Ursoliv 500

Ursoliv Dissolution of gallstones in patients w/ radiolucent, noncalcified, gallbladder stones (<20 mm diameter) in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesth or for patients who refuse surgery. Prevention of gallstone formation in obese patients experiencing rapid wt loss. Compensate primary biliary cirrhosis. Chronic cholestatic syndrome w/ various liver lesions. Ursoliv 500 Dissolution of cholesterol-rich gallstones in the bladder & for the treatment of biliary reflux gastritis & cholestatic liver disease. Symptomatic treatment of primary biliary cirrhosis in patients w/o decompensated hepatic cirrhosis.

Ursoliv Gallstones dissolution 8-10 mg/kg/day in 2 or 3 divided doses. Duration of therapy: 6-12 mth. It should be continued for at least 3 mth to promote dissolution of too small particles. Gallstone prevention 800 mg bid. Cholestatic liver diseases 13-15 mg/kg/day in 2 divided doses. Primary biliary cirrhosis 10-15 mg/kg/day in divided doses, 80-100 kg 4 caps daily, 60-80 kg 3 caps daily, up to 60 kg 2 caps daily. Ursoliv 500 Dissolution of cholesterol gallstones Approx 10 mg/kg, taken regularly in the evening at bedtime for 6-24 mth. Patient weighing >100 kg 2½ tab, 81-100 kg 2 tab, 61-80 kg 1½ tab, up to 60 kg 1 tab. Primary biliary cirrhosis 14 ± 2 mg/kg daily, taken as divided dose over the day for the 1st 3 mth. When liver function parameters improve, daily dose may be taken once daily in the evening. Patient weighing >110 kg 1 tab (morning), 1 tab (midday), 1½ tab (evening) for 1st 3 mth; subsequently, 3½ tab in the evening, 94-109 kg 1 tab (morning), 1 tab (midday), 1 tab (evening) for the 1st 3 mth; subsequently, 3 tab in the evening, 79-93 kg ½ tab (morning), 1 tab (midday), 1 tab (evening) for the 1st 3 mth; subsequently, 2½ tab in the evening, 63-78 kg ½ tab (morning), ½ tab (midday), 1 tab (evening) for 1st 3 mth; subsequently, 2 tab in the evening, 47-62 kg ½ tab (morning), ½ tab (midday), ½ tab (evening) for the 1st 3 mth; subsequently, 1½ tab in the evening.

Should be taken with food:

Hypersensitivity. Ursoliv Patients w/ gallstone complications eg, biliary-GI fistula, biliary obstruction, cholangitis, cholecystitis, pancreatitis or frequent biliary colic. Ineffective for the dissolution of calcified & pigment gallstones & is of no value in patients w/o a patent & functioning gallbladder. Ursoliv 500 Not to be used in patients w/ acute inflammation of the gall bladder or biliary tract, occlusion of the biliary tract, frequent episodes of biliary colic, radio-opaque calcified gallstones, impaired contractility of the gall bladder. When used in hepatobiliary disorders associated w/ cystic fibrosis in childn 6-18 yr: Unsuccessful portoenterostomy or w/o recovery of good bile flow in childn w/ biliary atresia.

Ursoliv Monitor LFTs upon treatment initiation, every 1-3 mth for the 1st 3 mth, & then every 6 mth during treatment; discontinue treatment if increased values persist. Should not be used during pregnancy & lactation w/o medical advice. Safety & efficacy have not been established in childn. Ursoliv 500 Monitor LFTs every 4 wk during the 1st 3 mth of treatment, thereafter every 3 mth. Do not use for dissolution of cholesterol gallstones if gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired gall bladder contractility or frequent episodes of biliary colic. Reduce dose in case of diarrhoea; discontinue in case of persistent diarrhoea. In rare cases, clinical symptoms of primary biliary cirrhosis may worsen at the beginning of treatment. Higher rates of serious adverse events in patients w/ primary sclerosing cholangitis on long-term, high-dose therapy. Female patients should use an effective non-hormonal method of contraception. Exclude possibility of pregnancy before beginning treatment. Not be used during pregnancy unless clearly necessary.

Ursoliv Allergy, cholecystitis, leucopenia, peptic ulcer & UTI. Ursoliv 500 Pasty stools or diarrhoea.

Ursoliv Impaired absorption & efficacy w/ Al-containing antacids, cholestyramine, colestipol, antihyperlipidemics especially clofibrate, estrogens, neomycin, OC or progestins. Ursoliv 500 Inhibited absorption & efficacy w/ cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Can affect absorption of ciclosporin from the intestine. Can reduce absorption of ciprofloxacin (isolated cases). Slightly elevated plasma levels of rosuvastatin. Reduced C_max & AUC of nitrendipine. Reduction of the therapeutic effect of dapsone was reported. Counter-effect w/ oestrogenic hormones & blood cholesterol lowering agents eg, clofibrate, due to their ability to increase hepatic cholesterol secretion & encourage biliary lithiasis.

Cholagogues, Cholelitholytics & Hepatic Protectors

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

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