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UDIOL

Ursodeoxycholic Acid 300mg Film Coated Tablet

SKU #: DMP-MD-414

Ursodeoxycholic Acid 300mg Film Coated Tablet contains a naturally occurring bile acid that helps improve bile flow, reduce the cholesterol content of bile, and protect liver cells from the harmful effects of retained bile acids.

FDA Registration Number: DRP-16214-01

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Pack size: 30 Tablets

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Product details

Generic Name:Ursodeoxycholic Acid

Category:Prescription Medicines

Brand:UDIOL

Strength:300mg

Dosage Form:Tablet

Indications

Used in selected hepatobiliary conditions, including primary biliary cholangitis and the dissolution of certain cholesterol gallstones in patients with a functioning gallbladder. It may also be used in other cholestatic liver disorders depending on the approved product labeling and specialist advice.

Contraindications

Hypersensitivity or allergy to ursodeoxycholic acid, other bile acids, or any component of the formulation.
Acute inflammation of the gallbladder or biliary tract.
Obstruction of the common bile duct or cystic duct.
Frequent episodes of biliary colic.
Calcified gallstones that cannot be dissolved with bile acid therapy.
Impaired gallbladder contractility when treatment is intended for gallstone dissolution.
Additional contraindications may apply depending on the specific registered product and clinical condition.

Warnings and Precautions

Treatment should be medically supervised, with liver function tests monitored periodically as clinically appropriate.
Persistent worsening of liver function tests or symptoms of liver disease should prompt medical evaluation.
Diarrhea may occur and may require dose adjustment or discontinuation if persistent.
When used for cholesterol gallstone dissolution, the gallstones should be suitable for bile acid therapy and treatment response may require periodic imaging.
Ursodeoxycholic acid may interact with bile acid-binding resins such as cholestyramine or colestipol and with aluminum-containing antacids, which can reduce its absorption. These medicines may need to be taken at different times.
Medicines that increase biliary cholesterol secretion, including some hormonal therapies, may reduce the effectiveness of gallstone dissolution.
Use with caution in patients with advanced liver disease or complications of portal hypertension and according to specialist guidance.
Use during pregnancy or breastfeeding should follow healthcare professional advice and the approved product information.
Do not stop or change treatment without medical advice.

Ursodeoxycholic Acid 300mg Film Coated Tablet

Product details

Indications

Contraindications

Warnings and Precautions

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