Urso 250 (ursodiol)
OTHER BRAND NAMES
Treatment of primary biliary cirrhosis.
Primary Biliary Cirrhosis
Usual: 13-15mg/kg/day given bid-qid
Take w/ food
Scored tab may be broken in halves; do not use segments broken incorrectly
Take unchewed w/ water
Tab: (Urso 250) 250mg, (Urso Forte) 500mg* *scored
Complete biliary obstruction.
Administer appropriate specific treatment in patients with variceal bleeding, hepatic encephalopathy, ascites, or in need of an urgent liver transplant. Monitor LFTs (gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, AST, ALT) and bilirubin levels monthly for 3 months after start of therapy, and every 6 months thereafter; consider treatment discontinuation if the parameters increase to a level considered clinically significant in patients with stable historical LFT levels. Use with caution to maintain bile flow.
Leukopenia, skin rash, peptic ulcer, blood glucose elevation, SrCr elevation, thrombocytopenia, diarrhea, abdominal pain, asthenia, nausea, dyspepsia, anorexia, esophagitis.
Bile acid sequestering agents (eg, cholestyramine, colestipol) and aluminum-based antacids may interfere with the action of the drug by reducing its absorption. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) may counteract effectiveness.
PREGNANCY AND LACTATION
Category B, caution in nursing.
MECHANISM OF ACTION
Bile acid; replaces and displaces toxic concentrations of endogenous hydrophobic bile acids. In addition, produces cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apoptosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.
Absorption: Passive diffusion, incomplete. Distribution: Plasma protein binding (≥70%) (unconjugated). Metabolism: Liver via conjugation. Elimination: Feces (primary), urine (<1%).
Assess for biliary obstruction, variceal bleeding, hepatic encephalopathy, ascites, need for an urgent liver transplant, hypersensitivity, intolerance, pregnancy/nursing status, and possible drug interactions.
Monitor for the development of adverse reactions. Monitor LFTs (GGT, alkaline phosphatase, AST, ALT) and bilirubin levels monthly for 3 months after start of therapy, and every 6 months thereafter.
Inform that adsorption may be reduced if taking concomitant bile acid sequestering agents, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol.
20-25°C (68-77°F). (Urso Forte) Half-tab: 20-25°C (68-77°F) in the current packaging for up to 28 days. Store separately from whole tabs.
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