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Uses
- Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established.
- Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
History
There is currently no drug history available for this drug.
Other Information
Ursodiol is a bile acid available as 300-mg capsules suitable for oral administration.
Ursodiol is ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structure is shown below:
Inactive Ingredients. Pregelatinized Starch, Colloidal Silicon Dioxide, Magnesium Stearate. The capsule shell consists of FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol, and Methanol.
Sources
Clarins Broad Spectrum Spf 15 Titanium Dioxide-sunscreen Extra-firming Foundation Tint 105 Manufacturers
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Laboratoires Clarins S.a.
Clarins Broad Spectrum Spf 15 Titanium Dioxide-sunscreen Extra-firming Foundation Tint 105 | Marlex Pharmaceuticals Inc
Gallstone DissolutionThe 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 re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
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