ACTIGALL

Actigall Generic Name & Formulations

Legal Class

General Description

Ursodiol 300mg; caps.

Pharmacological Class

Bile acid.

How Supplied

Caps—100

Manufacturer

Teva Pharmaceuticals

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

Metabolism

Hepatic.

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