Composition:
Each capsule contains:
Ursodiol…………………250 mg

Properties:
Ursodiol is a naturally occurring bile acid found in small quantities in normal human bile synthesized in the liver from 7-keto lithocholic acid.
It is markedly more hydrophilic than other bile acids. Its high polarity correlates with its low potential of forming micelles, a property that contributes for its extremely toxicity.
Following oral administration, most or Ursodiol is absorbed in the ileum, distributed only in the enter hepatic organs and plasma. In the liver; Ursodiol is conjugated with glysine or taurine.The drug is mostly distributed in bile and is mainly excreted in feces (99%) while urinary excretion is less than 1 %( except in severe cholestatic mechanisms).

Indications:
► Dissolution of gall stones in patients with radiolucent, noncalcified, cholesterol gallbladder stones <20 mm in greatest diameter.
► Chronic hepatitis
► Cholestatic liver diseases e.g. primary biliary cirrhosis.
► Prophylaxis against gallstone formation in obese patients who are rapidly losing weight.

Contraindications:
It should not be used in the following cases:
► Calcified cholesterol, radio opaque or radiolucent bile pigment stones (Ursodiol will not dissolve these stones).
► Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis,cholangitis biliary-gastrointestinal fistula.
► Allergy to bile acids.

Precautions:
Liver function tests should be performed during treatment period.

Drug interactions:
► Bile acid sequestering agents such as cholestyramine and colestipol and aluminum based antacids may interfere with the absorption of Ursodiol.
► Estrogen oral contraceptives and lipid lowering agents (such as colifibrate) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the efficacy of Ursodiol.

Dosage and administration:
► For gallstone dissolution…………..8-10 m/kg body weight/day as a single dose at bedtime or in two divided doses.
► Chronic hepatitis and cholestatis diseases ……10-15 mg/kg daily in 2-4 divided doses.
► or gallstones preventation…………………….600 mg/day in two divided doses

Use during pregnancy and lactation:
The drug should not be given during pregnancy as there have been no adequate studies of the use of Ursodiol in pregnant women.
Caution should be exercised when Ursodiol is given to a nursing mother, because many drugs are excreted in the human milk.

Storage: Keep at temperature not exceeding than 30°C.
Keep out of the reach of children

Packing:
Box containing 30 capsules