ursodeoxycholic acid


Dr Falk


Full Prescribing Info
Ursodeoxycholic acid.
Urdafalk contains ursodeoxycholic acid which suppresses hepatic synthesis and secretion of cholesterol and inhibits intestinal absorption of cholesterol. Ursodeoxycholic acid has little inhibitory effect on synthesis and secretion of endogenous bile acids, without affecting secretion of phospholipids into the bile.
Urdafalk converts cholesterol precipitates into readily soluble cholesterol by forming a lecithin cholesterol liquid layer on the surface of gallstones.
Radiolucent gallstones not exceeding 20 mm in diameter. Patients who are at increased risk or who refuse cholecystectomy. Advanced age. Idiosyncratic reactions to general anesthesia. Patients who refuse surgical intervention.
Safety of usage for >24 months has not been established.
Dosage/Direction for Use
8-10 mg/kg body weight in 2 or 3 divided cases, taken with milk or meal. (Usually 250 mg is given in the morning and in the afternoon.)
Urdafalk capsules must be taken regularly to ensure success.
Therapy should be reinstituted from the beginning if there is an interruption for 4 weeks.
Calcified cholesterol stones, radio-opaque stones or radiolucent bile pigment stones. Unremitting acute cholecystitis, cholangitis, biliary obstruction, pancreatitis or biliary-gastrointestinal fistula. Allergy to bile acids.
Special Precautions
Gallbladder stone dissolution with ursodeoxycholic acid requires months of therapy. Therefore, caution should be exercised during therapy with ursodeoxycholic acid and alternative therapies should be considered.
Complete dissolution does not occur in all patients and recurrence of stone within 5 years has been observed in up to 50% of patients.
Use in pregnancy & lactation: Ursodeoxycholic acid is not recommended for pregnant and nursing mothers.
Side Effects
Rare side effects include diarrhea, skin rash, urticaria, dry skin, cold sweat, hair loss, nausea, vomiting, indigestion, metallic taste, abdominal pain, biliary pain, cholecystitis, constipation, stomatitis, flatulence, dizziness, fatigue, anxiety, depression, sleep disorder, arthralgia, myalgia, back pain, cough and rhinitis.
Drug Interactions
Cholestyramine or aluminium hydroxide blocks the absorption of ursodeoxycholic acid.
Duration of Treatment: Pure cholesterol gallstones dissolve after a period of 6 months to 2 years. To ensure the success of therapy, bile ducts should be monitored by x-ray; if there is no change in gallstone size after 2 years, further treatment will not give good results.
Laboratory Monitor: Current scientific findings suggest that during the first 3 months of treatment for gallstone dissolution, the routine liver function tests (serum levels of transminases, bilirubin and alkaline phosphatase) should be determined fortnightly. Later, these tests need to be carried out every 3 weeks.
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Urdafalk cap 250 mg
30's (Rp284,350/pak)
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