Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Actigall Generic Name & Formulations
Legal Class
Rx
General Description
Ursodiol 300mg; caps.
Pharmacological Class
Bile acid.
How Supplied
Caps—100
Manufacturer
Generic Availability
YES
Mechanism of Action
Ursodiol (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also inhibits intestinal absorption of cholesterol.
Actigall Indications
Indications
Dissolution of radiolucent, noncalcified gallstones <20mm in diameter in patients who refuse cholecystectomy or are at increased risk during surgery. Prevention of gallstone formation in obese patients experiencing rapid weight loss.
Actigall Dosage and Administration
Adult
Dissolution: 8–10mg/kg per day in 2–3 divided doses. Prevention: 300mg twice daily.
Children
Not recommended.
Actigall Contraindications
Contraindications
Not for calcified, radio-opaque, or radiolucent bile pigment stones. Compelling need for cholecystectomy.
Actigall Boxed Warnings
Not Applicable
Actigall Warnings/Precautions
Warnings/Precautions
Risk for intestinal stenosis or stasis (eg, surgical enteroanastomoses, Crohn disease). Evaluate if obstructive GI symptoms develop. Obtain sonogram at 6 and 12 months. After complete dissolution, repeat sonogram in 1–3 months and then discontinue. Gallstones can recur. Measure SGOT (AST) and SGPT (ALT) at initiation and clinically indicated thereafter. Pregnancy: not recommended. Nursing mothers.
Actigall Pharmacokinetics
Elimination
Fecal.
Actigall Interactions
Interactions
Reduced absorption with bile acid sequestrants, aluminum-containing antacids. Estrogens, oral contraceptives, clofibrate, other lipid lowering drugs may reduce effectiveness by increasing hepatic cholesterol secretion.
Actigall Adverse Reactions
Adverse Reactions
Diarrhea; rare: enteroliths.
Actigall Clinical Trials
See Literature
Actigall Note
Not Applicable
Actigall Patient Counseling
See Literature
