Buy Urso Online

Urso 250 (ursodiol)

OTHER BRAND NAMES

Urso Forte

THERAPEUTIC CLASS

Bile acid

DEA CLASS

RX

INDICATIONS

Treatment of primary biliary cirrhosis.

ADULT DOSAGE

Primary Biliary Cirrhosis

Usual: 13-15mg/kg/day given bid-qid

ADMINISTRATION

Oral route

Take w/ food

Urso Forte
Scored tab may be broken in halves; do not use segments broken incorrectly
Take unchewed w/ water

HOW SUPPLIED

Tab: (Urso 250) 250mg, (Urso Forte) 500mg* *scored

CONTRAINDICATIONS

Complete biliary obstruction.

WARNINGS/PRECAUTIONS

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.

ADVERSE REACTIONS

Leukopenia, skin rash, peptic ulcer, blood glucose elevation, SrCr elevation, thrombocytopenia, diarrhea, abdominal pain, asthenia, nausea, dyspepsia, anorexia, esophagitis.

DRUG INTERACTIONS

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.

PHARMACOKINETICS

Absorption: Passive diffusion, incomplete. Distribution: Plasma protein binding (≥70%) (unconjugated). Metabolism: Liver via conjugation. Elimination: Feces (primary), urine (<1%).

ASSESSMENT

Assess for biliary obstruction, variceal bleeding, hepatic encephalopathy, ascites, need for an urgent liver transplant, hypersensitivity, intolerance, pregnancy/nursing status, and possible drug interactions.

MONITORING

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.

PATIENT COUNSELING

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.

STORAGE

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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