Urlyx/Urlyx 500 Special Precautions

Urlyx: Ursodeoxycholic acid should not be given to patients with intestinal and hepatic disorder that interfere with enterohepatic circulation of bile salts. It is ineffective for the dissolution of calcified and pigmented 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.
Urlyx 500: Carcinogenesis and Mutagenesis: Ursodeoxycholic acid have no carcinogenic, mutagenic or teratogenic effects in laboratory animals treated at higher doses than those intended for therapy in humans, and after long-term treatment.
Hepatic/Biliary/Pancreatic: Patients with visceral bleeding, hepatic encephalopathy ascites, or in need of an urgent liver transplant, should receive appropriate specific treatment. Caution should be exercised when UDCA is administered in a setting of partial biliary obstruction of extra-hepatic origin.
Monitoring and Laboratory Tests: Lithocholic acid, one of the metabolites of Ursodeoxycholic acid is hepatotoxic unless it is effectively detoxified in the liver.
Therefore, the following tests are important for patient monitoring: three months after start of therapy, and every six months thereafter. Serial monitoring will allow for the early detection of a possible deterioration of the hepatic function. Serum levels of these parameters usually decrease rapidly. Improved of adequate biochemical response to the treatment, UDCA discontinuation should be considered when serum liver function tests increase to a level considered clinically significant.
Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
Use in Pregnancy: There are no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ursodeoxycholic acid should not be used in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Use in Lactation: It is not known whether Urlyx 500 is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ursodeoxycholic acid is administered to a nursing mother.
Use in Children: The safety and effectiveness of Ursodeoxycholic acid in children have not been established.
Use in the Elderly: Appropriate studies with Ursodeoxycholic acid have not been performed in the geriatric population. However, geriatric-specific problems that would limit the use or usefulness of Ursodeoxycholic acid in the elderly are not expected.