ursodeoxycholic acid


Mega Lifesciences


Concise Prescribing Info
Ursodeoxycholic acid
Dissolution of gallstones in patients w/ radiolucent, noncalcified, gallbladder stones <20 mm diameter in whom elective cholecystectomy would be undertaken except for 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 w/ rapid wt loss. Compensated primary biliary cirrhosis. Chronic cholestatic syndrome w/ various liver lesions.
Dosage/Direction for Use
Gallstones dissolution 8-10 mg/kg daily in 2 or 3 divided doses. Duration: 6-12 mth. Continue for at least 3 mth to promote dissolution of too small particles. Gallstone prevention in obese patient 800 mg bd in 2-3 divided doses. Cholestatic liver disease 13-15 mg/kg daily in 2 divided doses. Primary biliary cirrhosis 10-15 mg/kg daily in divided dose: Patient weighing 80-100 kg 4 cap, 60-80 kg 3 cap, up to 60 kg 2 cap.
Should be taken with food.
Allergy to bile acids. 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 patent & functioning gallbladder.
Special Precautions
Discontinue if increased serum values persist. Measure SGPT, SGOT, GGT, ALP & bilirubin at initiation of therapy & thereafter. Monitor serum values upon initiation, every 1-3 mth for 1st 3 mth, & then every 6 mth during treatment. Pregnancy & lactation. Childn.
Adverse Reactions
Allergy, cholecystitis, leucopenia, peptic ulcer & UTI.
Drug Interactions
Impaired absorption & efficacy by Al-containing antacids, cholestyramine, colestipol, antihyperlipidemics especially clofibrate, estrogens, neomycin, OCs or progestins.
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Ursomax cap 250 mg
5 × 10's
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