Each tablet contains ursodeoxycholic acid 300 mg.
Pharmacology: Pharmacokinetics: Ursodeoxycholic acid is absorbed from the gastrointestinal tract and undergoes enterohepatic recycling. It is partly conjugated in the liver before being excreted into the bile. Under the influence of intestinal bacteria, the free and conjugated forms undergo 7α-dehydroxylation to lithocholic acid, some of which is excreted directly in the faeces and the rest is absorbed and mainly conjugated and sulfated by the liver before excretion. However, in comparison with chenodeoxycholic acid less ursodeoxycholic acid undergoes such bacterial degradation.
It is used for the dissolution of cholesterol-rich gallstones in patients with functioning gall bladders. It is also used in primary biliary cirrhosis.
Adult: 300 mg, three times a day with meals.
Or as prescribed by the physician.
Do not administer the drug to the following patients: Patients with hypersensitivity to its components; patients with complete obstruction of biliary tract (choleretic actions may aggravate the symptoms); patients with fulminant hepatitis; patients with radiopaque calcifying cholelithiasis; patients with nonfunctioning gall bladder or acute cholecystitis; pregnant women or women suspected of being pregnant; pediatric patients; patients with renal disease; patients with gastric ulcers (acute gastroduodenal ulcers); patients with colitis or enteritis such as Crohn's disease.
Ursodeoxycholic acid should not be given to patients with peptic ulcer disease, inflammatory bowel disease, or chronic liver disease. Its use should be avoided in pregnancy.
General Precautions: The following patients should see a physician before taking this drug: Patients with severe pancreatic disease; patients with choledochalithiasis; patients with variceal bleeding, hepatic encephalopathy, ascites and those in need of an urgent liver transplantation.
The drug should be administered with caution in the following patients: Careful administration should be exercised in patients with jaundice and hepatic cirrhosis.
Regularly check the level of liver enzymes (ALT, AST, γ-GT, ALP, total bilirubin).
There is a faint chance that an overdose causes a severe adverse event. If necessary, perform liver function test.
There is no evidence that dose adjustment in geriatric patients is necessary. However, appropriate precautions should be exercised such as reducing the dose because the physical functions in elderly patients generally decline.
Ursodeoxycholic acid should be avoided in pregnancy.
Diarrhea, vomiting, nausea, abdominal pain, constipation, heartburn, epigastric discomfort.
Fever, cough, dyspnea.
Rarely, general malaise, dizziness, calcification of cholelithiasis, increase in ALT, ALP, AST, γ-GT, decrease in leukocyte.
Increase in serum bilirubin.
Concurrent administration of oral hypoglycemic agent (Tolbutamide); should be cautiously administered to patients with diabetes because ursodeoxycholic acid may increase the effects of oral hypoglycemic agents.
The following may reduce the absorption of this drug: Cholestyramine, cholestipol, charcoal, aluminum hydroxide and magnesium-based antacids; cholesterol-reducing drugs in bile (e.g. Oral contraceptives containing estrogens) or cholesterol-reducing drugs in serum (e.g. clofibrate); drugs which induce liver injury.
Store at temperatures not exceeding 30°C.
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.