Search The Medical Knowledge Base

Drug Details

Urdox 300mg Film-Coated Tablets, Ursodeoxycholic Acid 300mg Film-Coated Tablets

• Drug Class Description
  Bile acids.
• Generic Name
  Ursodeoxycholic acid
• Presentation
  Film coated tablets Urdox tablets are white. film coated, convex tablets with “URDOX” on one side.
• Description
  Ursodeoxycholic acid 300mg. Excipients: lactose
• Indications
  

  Urdox tablets are indicated for the dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in functioning gall bladders.

  Cholesterol stones coated with calcium or stones composed of bile pigments are not dissolved by ursodeoxycholic acid. Urdox has a particular place in the treatment of patients in whom surgery is contraindicated or who are anxious to avoid surgery.

• Adult Dosage
  

  The usual dose is 6 - 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary.

  The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s).

• Child Dosage
  Not recommended.
• Elderly Dosage
  See Adult Dosage
• Contra Indications
  

  1. Use in patients with radio-opaque calcified gall-stones, or in those with non-functioning gall bladders.

  2. Use in women who may become pregnant.

  3. Use in patients with chronic liver disease, peptic ulcers or in those with inflammatory diseases of the small intestine and colon.

• Special Precautions
  

  Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

• Interactions
  

  Urdox tablets should not be administered with oral contraceptives, oestrogenic hormones and other drugs which reduce the blood cholesterol level and increase the bile cholesterol level.

  Antacids bind bile acids in the gut. Drugs such as charcoal, colestipol and cholestyramine bind bile acids in vitro. All the above should be avoided during bile acid therapy as they may limit the effectiveness of therapy. Ursodeoxycholic acid may increase the absorption and serum levels of ciclosporin in some patients.

• Adverse Drug Reactions
  

  Urdox may give rise to nausea, vomiting, diarrhoea and pruritus. A calcified layer may develop on the surface of the stone making it unable to be dissolved by bile acid therapy, resulting in surgery for some patients.