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  • Ursolit
    / CTS


    Active Ingredient
    Ursodeoxycholic Acid 100 mg, 300 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    100 X 100 mg

    full basket chart 2318 21037

    Tablets

    60 X 100 mg

    full basket chart 84927 21110

    Tablets

    30 X 300 mg

    full basket chart 8709 21029

    Related information


    Dosage

    Gallstone dissolution: 8 to 12 mg/kg/day given in 2 divided doses.
    If doses are unequal the larger dose should be taken in late evening to counteract the rise in biliary cholesterol saturation which occurs in the early morning. The late evening dose may usefully be taken with food to help maintain bile flow overnight.
    The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition. Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared.
    Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter.
    The efficiency of Ursolit in treating radio-opaque or partially radio opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones.
    Non-cholesterol stones account for 10-15% radiolucent stones and may not be dissolved by bile acids.
    Chronic liver diseases: 10 to 15 mg/kg/day administered in 2 to 4 divided doses with food. The dose may be adjusted according to the patient’s age and severity of symptoms.


    Indications

    Dissolution or reduction in size of radiolucent cholesterol in patient with a functioning gallbladder.
    Treatment of chronic liver diseases including primary billiary cirrhosis, primary sclerosing cholangitis, cystic fibrosis associated liver disease, billiary atresia, chronic hepatitis, and alcohol cirrhosis.


    Contra-Indications

    – With hypersensitivity to bile acids or any of the excipients.
    – With radio-opaque calcified gallstones
    – With occlusion of the biliary tract (occlusion of the common bile duct or cystic duct).
    – With acute inflammation of the gall bladder or biliary tract.
    – With frequent episodes of biliary colic
    – With impaired contractility of the gall bladder.
    – With chronic liver disease, peptic ulcers or in those with inflammatory diseases of the small intestine and colon.


    Special Precautions

    NOTE: Length of therapy: Gallbladder stone dissolution requires months of therapy. Complete dissolution does not occur in all patients, and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Carefully select patients for Ursolit therapy and consider alternative therapies. Ursolit tablets should be carefully administered to biliary cirrhosis patients with severe jaundice since symptoms may be aggravated. If increases in serum bilirubin or other changes are observed, appropriate remedial actions such as discontinuation of administration should be taken. Periodic tests of liver functions, renal clearance and blood differential counts should be performed. In case of treatment intended for the dissolution of gallstones – ultrasonograms to monitor stone dissolution should be performed. Excessive dietary intake of calories and cholesterol should be avoided. A low cholesterol diet
    will probably improve the effectiveness of Ursolit. Ursolit tablets should be administered with care to following patients:
    Patients with impaired function of kidneys/urinary system.
    Patients with impaired function of the liver.
    Patients with severe pancreatic diseases (The underlying disease may be aggravated.)
    Patients with peptic ulcers (Symptoms may be aggravated due to mucosal irritation).
    Patients with gallstones in the bile duct (Bilary stasis may be induced due to cholagogic effects).
    Pregnancy: it is recommended that Ursolit 100 mg tablets and Ursolit 300 mg tablets not be administered to pregnant patients or patients suspected of being pregnant.
    Lactation: It is not known whether Ursolit is excreted in breast milk. Exercise caution when Ursolit is administered to a nursing mother.
    Elderly: Since physiological function is generally reduced in elderly patients, Ursolit should be administered in those patients with particular precaution for dosage.
    Children: Safety and efficacy for use in children have not been established.
    Women of childbearing age: should take this drug only when non-hormonal contraceptive measures are used.
    Use in pediatrics: The safety and effectiveness in children have not been established. Periodic tests of liver function, renal clearance and blood differential counts should be performed. A low cholesterol diet will probably improve the effectiveness.
    Children: Safety and efficacy for use in children have not been established.


    Side Effects

    Nausea, vomiting, loose stools and diarrhea have been reported rarely.


    Drug interactions

    Ursolit tablets should be administered with care when coadministered with following drugs:
    Antacids (aluminium hydroxide gel, etc). Aluminium based antacids adsorb bile acids in vitro and interfere with the action of Ursolit by reducing its absorption. Colestyramine, colestipol,charcoal – may interfere with the action of Ursolit by delaying or reducing its absorption.
    Clofibrate, estrogens, oral contraceptives. These agents (and perhaps other lipid-lowering drugs), increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation, and hence, may counteract the effectiveness of Ursolit. Oral antidiabetic sulfonylurea (tolbutamide, etc) – hypoglycemic effects may be enhanced. UDCA may increase the absorption of cyclosporin in transplantation patients.


    Pregnancy and Lactation

    Pregnancy: it is recommended that Ursolit 100 mg tablets and Ursolit 300 mg tablets not be administered to pregnant patients or patients suspected of being pregnant.
    Lactation: It is not known whether Ursolit is excreted in breast milk. Exercise caution when Ursolit is administered to a nursing mother.


    Overdose

    The most likely manifestation of severe overdose would probably be diarrhea; treat symptomatically. Treatment includes usual supportive measures. If necessary, ion-exchange resins may be used to bind bile acids in the intestines.


    Manufacturer
    CTS Chemical Industries Ltd
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