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ACTIGALL
Digestive and biliary disorders
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Drug Name:

ACTIGALL Rx

Generic Name and Formulations:
Ursodiol 300 mg; caps.

Company:
Allergan

Therapeutic Use:

Indications for ACTIGALL:

Dissolution of radiolucent, noncalcified gallstones <20 mm 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.

Adult:

Dissolution: 8–10mg/kg per day in 2–3 divided doses. Prevention: 300mg twice daily.

Children:

Not recommended.

Contraindications:

Not for calcified, radio-opaque, or radiolucent bile pigment stones. Compelling need for cholecystectomy.

Warnings/Precautions:

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 start, 1 and 3 months later, and then every 6 months; monitor frequently if levels increase, and discontinue if elevations persist. Pregnancy (Cat.B): not recommended. Nursing mothers.

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.

Pharmacological Class:

Bile acid.

Adverse Reactions:

Diarrhea.

How Supplied:

Caps—100

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