ursodeoxycholic acid




InnoGen Pharmaceuticals
Full Prescribing Info
Ursodeoxycholic acid.
Each capsule contains: Ursodeoxycholic acid 250 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 7a-dehydroxylation to lithocholic acid, some of which is excreted directly in the faeces and the rest absorbed and mainly conjugated and sulfated by the liver before excretion in the faeces. However, in comparison with chenodeoxycholic acid, less ursodeoxycholic acid undergoes such bacterial degradation.
Ursodeoxycholic acid suppresses the synthesis and secretion of cholesterol by the liver inhibits intestinal absorption of cholesterol. It is used for the dissolution of cholesterol-rich gallstones in patients with functioning gallbladders.
Dosage/Direction for Use
Initial dose 1 capsule every 8 hours or as prescribed by the physician.
Complete atresia of bile duct, radio opaque calcified gallstones, nonfunctional gallbladder, acute cholecystitis.
Special Precautions
Ursodeoxycholic acid should not be given to patients with intestinal and hepatic disorders that interfere with entero-hepatic circulation of bile salts. It is ineffective for the dissolution of calcified and pigment gallstones and is of no value in patients without a patent and a functioning gallbladder. Licensed product information recommends that its use should be avoided in pregnancy.
Use In Pregnancy & Lactation
Licensed product information recommends that ursodeoxycholic acid use should be avoided in pregnancy.
Adverse Reactions
Ursodeoxycholic acid may cause nausea, vomiting and other gastrointestinal disturbances; diarrhea is reported to occur less frequently than with chenodeoxycholic acid. Increased liver enzyme value are also less likely. Pruritus may occur. Treatment with ursodeoxycholic acid may cause more calcification of cholesterol stones than chenodeoxycholic acid.
Drug Interactions
Ursodeoxycholic acid should not be used with drugs that increase bile cholesterol such as oestrogenic hormones and cholesterol-lowering drug such as clofibrate. Use with bile-acid binding drugs including antacids, charcoal, and cholestyramine should be avoided since this may reduce the effectiveness of therapy with ursodeoxycholic acid.
Store at temperatures not exceeding 30°C.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Cap 250 mg x 100's.
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