Use only if clearly necessary during pregnancy. Caution when administered to lactating mother.
Urlyx Not to be given to patients w/ intestinal & hepatic disorder that interferes w/ enterohepatic circulation of bile salts. Ineffective for the dissolution of calcified & pigmented gallstones & is of no value in patients w/o patent & functioning gallbladder. Not to be used w/ drugs that increase bile cholesterol eg, estrogenic hormones & cholesterol-lowering drug (eg, clofibrate). Avoid concomitant use w/ bile acid binding drugs including antacids, charcoal & cholestyramine.
Urlyx 500 Not indicated for decompensated cirrhosis. Exercise caution to maintain bile flow of patients; when administered in a setting of partial biliary obstruction of extra-hepatic origin. Monitor serum LFTs (γ-GT, alkaline phosphatase, AST, ALT) & bilirubin level every mth for 3 mth after start of therapy & every 6 mth thereafter. Consider discontinuation when serum LFTs increase to level considered clinically significant. Not to be administered concomitantly w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Women of childbearing potential should use reliable contraception (eg, non-hormonal or low-oestrogen oral contraceptives). Safety & effectiveness in childn have not been established.