Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16 — 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.
The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 — 10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
NDC: 68151-2987-0 1 CAPSULE in a PACKAGE
Ursodiol 300 mg capsulesLabel Image
| URSODIOL |
|Labeler — Carilion Materials Management (079239644)|
|Carilion Materials Management||079239644||REPACK (68151-2987)|
Revised: 08/2016 Carilion Materials Management
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