Information

The active ingredient of URSODEX is Ursodeoxycholic Acid, a bile acid which is normally present in bile. Ursodeoxycholic acid is an epimer of chenodeoxycholic acid. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.

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Therapeutic Class

Bile Acid Preparations/Anticholelithic Agent

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Dose and Direction of Use

Take the medication as directed by your doctor and as mentioned on the label. Unless told differently, swallow the tablet with water. 

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Mode of Action

The mechanism of action of UDCA in liver and cholestasis disorders has not yet been explained totally. However, UDCA alters bile acid composition, resulting in increases in the concentration of UDCA and decreases in the concentrations of the more hydrophobic and potentially toxic bile acids, cholic and chenodeoxycholic acids. UDCA also has a choleretic effect, resulting in increased bile acid output and bile flow. There is some evidence for immunological effects, including a reduction of abnormal expression of HLA Class I antigens on hepatocytes and a suppression of immunoglobulin and cytokine production. The Ursodeoxycholic acid converts lithogenic bile in non-lithogenic bile and gradually dissolves the cholesterol gallstones.

 

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Uses

• Treatment of primary biliary cirrhosis (PBC)
• Dissolution of gallstones
• Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years.
• Intrahepatic cholestatis of Pregnancy (ICP)

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Contraindications

Don't use this medication if you have:

• Acute inflammation of the gallbladder or biliary tract. 
• Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct).
• Frequent episodes of biliary colic.
• Radio-opaque calcified gallstones.
• Impaired contractility of the gallbladder.
• Non functioning gall bladder.
• Hypersensitivity to bile acids
• Inflammatory bowel disease
• Hepatic and intestinal conditions interfering with enterohepatic recirculation of bile acids
• Extrahepatic cholestasis
• Intrahepatic cholestasis
• Ileal resection
• Regional ileitis
• Ileal stoma
• Acute, chronic or severe liver disease
• Active duodenal ulcer
• Active gastric ulcer
• In paediatrci population with unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia

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Precautions and Warning

• Ursodeoxycholic acid should be taken under medical supervision.
• Have regular liver function test.
• It contains lactose, so consult your doctor if you have tolerance to some sugar.
• Mention if you are taking any other medications like oral contraceptive drugs as it can affect the work of Ursodeoxycholic Acid.
• Consult with your doctor if you are pregnant or breast feeding woman before taking this medicine to understand the risk and benefit ratio.
• Talk to your doctor about past medical history like kidney problem or liver problem before taking this medicine
• Don't double the dose for the missed one.
• Complete the prescribed dose and duration of medicine.

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