Product Information
Registration Status: ActiveSIN14545P
URSOFALK FILM-COATED TABLET 500MG is approved to be sold in Singapore with effective from 2014-02-05. It is marketed by DCH AURIGA SINGAPORE, with the registration number of SIN14545P.
This product contains Ursodeoxycholic Acid 500mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Losan Pharma GmbH in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Ursodeoxycholic acid is an epimer of chenodeoxycholic acid (DB06777). It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic. [PubChem]
Indication
The drug reduces cholesterol absorption and is used to dissolve (cholesterol) gallstones in patients who want an alternative to surgery.
Mechanism of Action
Ursodeoxycholic acid reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells. The main mechanism if anticholelithic. Although the exact process of ursodiol's anticholelithic action is not completely understood, it is thought that the drug is concentrated in bile and decreases biliary cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting its intestinal absorption. The reduced cholesterol saturation permits the gradual solubilization of cholesterol from gallstones, resulting in their eventual dissolution.
Toxicity
Neither accidental nor intentional overdosing with ursodeoxycholic acid has been reported. Doses of ursodeoxycholic acid in the range of 16-20 mg/kg/day have been tolerated for 6-37 months without symptoms by 7 patients. The LD50 for ursodeoxycholic acid in rats is over 5000 mg/kg given over 7-10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodeoxycholic acid would probably be diarrhea, which should be treated symptomatically.
Active Ingredient/Synonyms
(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid | (3α,5β,7β)-3,7-dihydroxycholan-24-oic acid | 3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid | Acide ursodesoxycholique | Acido ursodeossicolico | Acido ursodeoxicolico | Acidum ursodeoxycholicum | UDCA | Ursodeoxycholate | Ursodeoxycholic acid | Ursodiol | Ursodeoxycholic acid |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.