Ursodeoxycholic acid

Class
Cholelitholytics
Subclass
Semisynthetic bile acids
Substance name
Ursodeoxycholic acid, ursodiol, UDCA
Brand names
Reltone®
Common formulations
Capsule
Dosage and administration
Adults patients
Treatment
Gallstone disease • Radiolucent, noncalcified
•
8-10 mg/kg PO daily, in 2-3 divided doses
Primary biliary cholangitis
•
13-15 mg/kg PO daily, in 2-4 divided doses
Prevention
Prevention of gallstone disease in patients with obesity • Experiencing rapid weight loss
•
300 mg PO BID
Indications for use
Labeled indications
Adults
•
Treatment of choledocholithiasis
•
Treatment of gallstone disease (radiolucent, noncalcified)
•
Treatment of primary biliary cholangitis
•
Prevention of gallstone disease in patients with obesity (experiencing rapid weight loss)
Safety risks
Contraindications
Hypersensitivity to bile acids
Compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula
For calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones
Warnings and precautions
Biliary obstruction, intestinal stricture
•
Use caution in patients with medical conditions that predisposed them to intestinal stenosis or stasis.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
Use with caution. Monitor serum aminotransferases. Monitor for toxicity.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Avoid use. Evidence of fetal harm in animals. The possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Back pain, diarrhea, dizziness, headache, indigestion, nausea, vomiting, upper respiratory tract infections
Common 1-10%
•
Acute cholecystitis, allergic reactions, alopecia, arthritis, bronchitis, ↓ WBC count, ↓ platelet count, ↑ blood glucose, ↑ serum creatinine, influenza, peptic ulcer disease, pharyngitis, constipation, cough, flatulence, musculoskeletal pain, skin rash, urinary tract infections
Unknown frequency
•
AF, dermatitis herpetiformis, ↑ serum ALP, ↑ serum ALT, ↑ serum AST, ↑ serum TBIL, ↑ serum gamma-glutamyltransferase, jaundice, lichenoid dermatitis, epigastric abdominal pain
Interactions
Drug(s)
Check Interactions
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