Antigall(Ursodeoxycholic Acid)

Therapeutic Group: Bile Acid

Presentation

Antigall 150 Tablet: Each film-coated tablet contains Ursodeoxycholic Acid BP 150 mg.

Antigall 300 Tablet: Each film-coated tablet contains Ursodeoxycholic Acid BP 300 mg

Description

Ursodeoxycholic Acid is a naturally-occurring bile acid used to treat different hepatobiliary disorders. It decreases the secretion of cholesterol in different ways in the bile:

Ursodeoxycholic Acid reduces cholesterol absorption and suppresses liver cholesterol synthesis. But it does not inhibit bile acid synthesis

Indications

• Dissolution of small to medium-sized radiolucent, noncalcified gall bladder stones in functioning gall bladders

• Prevention of gallstone formation in obese patients experiencing rapid weight loss

• Primary biliary cirrhosis

Dosage & Administration

For adults & elderly:
Dissolution of gallstone: 8 – 10 mg/kg/day given in 2 or 3 divided doses.
Prevention of gallstone formation: 300 mg twice daily.
Primary biliary cirrhosis: 13 – 15 mg/kg/day in 2 to 4 divided doses with food.

Side Effects

This drug may give rise to nausea, vomiting, dizziness, headache, dyspepsia, diarrhea,
abdominal pain and pruritus.

Precautions

Excessive diatery intake of calories and cholesterol should be avoided. Liver function tests
and bilirubin levels should be monitored every month for three months after start of
therapy, and every six months thereafter

Use in Pregnancy & Lactation

Pregnancy category B. There is no adequate and well-controlled studies in pregnant and
lactating women. This drug should be used only if the benefit outweighs the risk. It is not
not known whether Ursodeoxycholic Acid is excreted in human milk. So, caution should be
exercised when it is administered to a lactating mother

Drug Interaction

This drug should not be administered with oral contraceptive, oestrogenic hormones and
other drugs which reduce the blood cholesterol level and increase the bile cholesterol
level. Concomitant administration with bile acid binding drugs including antacids, charcoal
and cholestyramine should be avoided. Since this may reduce the effectiveness of the
therapy with Ursodeoxycholic Acid.

Over Dose

It is unlikely that overdose will cause serious side effects. Diarrhoea may occur and it is
recommended that liver function test to be monitored

Commercial Pack

Antigall 150 tablet: Each box contains 3 Alu-PVDC blister strips of 10 tablets.
Antigall 300 tablet: Each box contains 2 Alu-PVDC blister strips of 10 tablets