Generic

Ursodeoxycholic Acid

Indications

Dissolution of small to medium sized radiolucent, cholesterol rich gallstones in functioning gallbladder, prevention of gallstone formation in obese patients experiencing rapid weight loss, primary biliary cirrhosis.

Pharmacology

Ursodeoxycholic Acid is a naturally occurring bile acid that is used to treat a variety of hepatobilliary conditions. Ursodeoxycholic Acid’s action is based on a reduction in cholesterol production in the bile. Ursodeoxycholic Acid does this by reducing cholesterol absorption, suppressing liver cholesterol synthesis, and not inhibiting bile acid synthesis.

Ursodeoxycholic Acid is a naturally occurring bile acid that is used to treat a variety of hepatobilliary conditions. Ursodeoxycholic Acid’s action is based on a reduction in cholesterol production in the bile. Ursodeoxycholic Acid does this by reducing cholesterol absorption, suppressing liver cholesterol synthesis, and not inhibiting bile acid synthesis.

In the upper gut, ursodeoxycholic acid is entirely absorbed. The time it takes for serum concentration to reach its peak ranges from 30 to 150 minutes. Absorption rates range from 60 to 80 percent. Ursodeoxycholic Acid enters the portal vein after absorption and is extracted from portal circulation by the liver, where it is conjugated with an amino acid (glycine or taurine) and released into the hepatic bile ducts. Ursodeoxycholic Acid is found in small concentrations in the circulation and eliminated in minor amounts in the urine. Ursodeoxycholic Acid has a biologic half-life of 3.5 to 5.8 days.

Dosage & Administration

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Interaction

It should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and
cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

Contraindications

Contraindicated to pigmented gallstones, non-functioning gall bladder, inflammatory diseases and other conditions of the small intestine, colon and liver which interfere with entero-hepatic circulation of bile salts.

Side Effects

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone calcification, pruritus.

Pregnancy & Lactation

Pregnancy classification B. There has been no indication of damage in pregnancy. It has been used successfully to treat cholestasis of pregnancy throughout the third trimester with no adverse effects. Breast feeding problems in humans have not been established.

Precautions & Warnings

It should be taken with caution in those who have liver problems.

Therapeutic Class

Anti-gallstones drugs: Bile Acids

Storage Conditions

Keep the temperature below 25° C. Light and moisture are kept out. Keep the medicine out of children’s reach.

Pharmaceutical Name

ACME Laboratories Ltd.