Generic

Ursodeoxycholic Acid

Indications

Cholestasis (Jaundice), Viral Hepatitis, Alcoholic Fatty Liver, Primary Billiary Cirrhosis (PBC), and Primary Sclerosing Cholangitis are all conditions that Ursodeoxycholic Acid is used to treat (PSC) , Gallstones Dissolution and Non-Alcoholic Steato Hepatitis (NASH).

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.

As a result, the composition of bile changes from supersaturated to unsaturated. Ursodeoxycholic Acid also aids the transfer of cholesterol from the gallbladder into the intestine for expulsion by promoting the development of liquid cholesterol crystal complexes. Ursodeoxycholic acid helps to treat cholestatic liver disease by protecting cholangiocytes against hydrophobic bile acid cytotoxicity.

• Hepatobilliary secretion stimulation
• Hepatocytes are protected from bile acid-induced apoptosis.

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

Ursodeoxycholic Acid should not be used with medications that raise bile cholesterol, such as oestrogenic hormones. Concurrent administration of Ursodeoxycholic acid with bile-acid binding medicines such as antacids, charcoal, or cholestyramine should be avoided, since this may diminish the efficiency of Ursodeoxycholic acid therapy.

Contraindications

Inflammatory intestinal illness, non-functioning gallbladder, calcified and pigmented gallstones.

Side Effects

Nausea, vomiting, diarrhoea, gallstone opacilication, and pruritus are all common adverse effects.

Pregnancy & Lactation

Category B pregnancy. In pregnancy, no indication of danger has been reported. It has been successfully used to treat cholestasis in pregnant women throughout the third trimester with no negative effects. Breast-feeding problems have not been documented in humans.

Precautions & Warnings

It should be used with caution by people who have liver illness.

Therapeutic Class

Anti-gallstones drugs: Bile Acids.

Storage Conditions

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.

Pharmaceutical Name

General Pharmaceuticals Ltd.