Description
Ursodec (Ursodeoxycholic Acid) 300 mg
Ursodec 300 mg contains ursodeoxycholic acid, also called ursodiol. It is a bile acid medicine used in selected hepatobiliary conditions, especially cholestatic liver disease, and it is also used for certain cholesterol gallstones. Official prescribing information describes it as a prescription bile acid with established clinical uses in specific liver and biliary disorders.
Active Ingredient and Medicine Class
The verified active ingredient is ursodeoxycholic acid. It belongs to the bile acid class and is considered a hydrophilic, hepatobiliary agent.
Established Medical Uses
Regulatory prescribing information supports use in primary biliary cholangitis and in the dissolution of certain radiolucent cholesterol gallstones in patients with a functioning gallbladder. Clinical reviews also describe its established role in improving biochemical features of cholestasis in several cholestatic liver disorders.
How It Works
Ursodeoxycholic acid helps make bile less damaging and may improve bile flow. Review literature describes several actions: it can reduce the toxic effects of more hydrophobic bile acids, stimulate hepatobiliary secretion, and help protect liver cells from bile-acid injury and apoptosis.
Important Safety Information
Prescribing information lists complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any formulation component as contraindications. It should be used cautiously in patients with significant biliary or liver disease, and its use depends on the specific condition being treated. Clinically important interactions have been reported with bile acid sequestrants, antacids containing aluminium, and drugs that can alter bile composition or liver tests.
Possible Side Effects
Commonly reported adverse effects include diarrhoea, abdominal discomfort, nausea, and other gastrointestinal symptoms. Important but less common serious reactions can include worsening liver test abnormalities, calcification of gallstones during stone dissolution therapy, and hypersensitivity reactions.
Scientific Evidence
Peer-reviewed reviews support ursodeoxycholic acid as a standard treatment in cholestatic liver disease, with evidence for biochemical improvement and symptomatic benefit in selected conditions. The strongest established clinical role remains in cholestatic disorders such as primary biliary cholangitis; evidence is weaker or inconsistent in many non-cholestatic liver diseases.
Medical Information Notice
This summary is based on sources available at the time of review and is provided for educational purposes only. It does not replace the official patient leaflet, prescribing information, or assessment by a qualified healthcare professional.
Medical Sources
- DailyMed — Ursodiol Capsules, USP Prescribing Information
- Paumgartner G, Beuers U. Ursodeoxycholic acid in cholestatic liver disease: mechanisms of action and therapeutic use revisited. Journal of Hepatology. 2002.