Monograph Details
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Gastrointestinal Tract
> Digestive and biliary disorders
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ACTIGALL |
| Manufacturer |
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Watson Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Bile acid. |
| Generic Name |
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Ursodiol 300 mg; caps. |
| Indications |
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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. |
| Children |
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Not recommended. |
| Adults |
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Dissolution: 8–10 mg/kg per day in 2–3 divided doses. Prevention: 300 mg twice daily. |
| Contraindications |
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Not for calcified, radio-opaque, or radiolucent bile pigment stones. Compelling need for cholecystectomy. |
| Precautions |
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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 |
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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. |
| Adverse Reactions |
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Diarrhea. |
| How Supplied |
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Caps—100 |
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