Ursodeoxycholic Acid Tablet IP 150mg

Ursodeoxycholic Acid Tablet IP 150mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Ursodeoxycholic Acid Tablet IP 150mg
  
• Ursodeoxycholic Acid Tablet IP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

•  a) Ursodeoxycholic Acid Tablet 150mg
  Each Uncoated tablet contains:
  Ursodeoxycholic Acid IP………………150mg
  Excipients…………………………q.s.
• b) Ursodeoxycholic Acid Tablet 300mg
  Each Uncoated tablet contains:
  Ursodeoxycholic Acid IP………………300mg
  Excipients…………………………q.s.

 THERAPEUTIC INDICATIONS:

• Ursodeoxycholic acid is a medication used in the management and treatment of cholestatic liver disease. This activity reviews the indications, mechanism of action, and contraindications for UDCA as a valuable agent in managing liver disease

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
  
• SCHEDULE “H” Prescription Drug-Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
  

STORAGE & DOSAGE:

• Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage: As directed by the Physician.

FAQ Ursodeoxycholic 150mg Tablets

What is Ursodeoxycholic 150 mg Tablets Used For?

Ursodeoxycholic acid 150 mg tablets are primarily used to treat and manage certain liver and gallbladder conditions. This medication belongs to the class of bile acid derivatives and is particularly effective in dissolving small cholesterol gallstones in patients for whom surgery isn’t an option. It is also extensively prescribed for the treatment of primary biliary cholangitis (PBC), a chronic autoimmune liver disease that damages the bile ducts. Additionally, Ursodeoxycholic acid (commonly abbreviated as UDCA) is employed to improve bile flow in cases of cholestatic liver diseases, thereby protecting liver cells from bile acid-induced damage.

What is Ursodeoxycholic Acid Tablet Used For?

Ursodeoxycholic acid tablets serve several crucial therapeutic roles, including:

• Dissolving cholesterol gallstones in patients unwilling or unable to undergo surgery.

• Managing primary biliary cholangitis, a life-altering condition characterized by progressive destruction of bile ducts within the liver.

• Treating intrahepatic cholestasis of pregnancy (ICP), a liver disorder during pregnancy that can cause severe itching and complications.

• Protecting hepatocytes from the toxic effects of accumulated bile acids.

• Improving liver enzyme levels, reducing inflammation, and preserving liver function.

• Supporting patients with cystic fibrosis-related liver disease or non-alcoholic fatty liver disease (NAFLD).

Is Ursodeoxycholic Acid Tablet Safe for Kidneys?

Ursodeoxycholic acid is generally considered safe for the kidneys. It is primarily metabolized by the liver and excreted in the bile, with only minimal amounts excreted by the kidneys. There is no significant evidence linking UDCA to renal toxicity or deterioration in kidney function when administered within the recommended therapeutic doses. However, it is essential for patients with pre-existing renal impairment to use this medication under strict medical supervision, ensuring proper monitoring of both liver and kidney parameters throughout the treatment course.

Is Ursodeoxycholic Acid Tablet Good for Liver?

Ursodeoxycholic acid is highly beneficial for liver health, particularly in managing chronic cholestatic liver diseases. Its hepatoprotective action involves reducing the concentration of toxic bile acids, enhancing bile flow, and protecting liver cells from apoptosis (cell death). Ursodeoxycholic acid has demonstrated excellent results in:

• Improving liver enzyme levels, such as ALT, AST, ALP, and GGT.

• Delaying disease progression in primary biliary cholangitis and other chronic liver diseases.

• Reducing inflammation and fibrosis, which helps in maintaining liver structure and function.

• Preventing the formation of new gallstones in patients with rapid weight loss or those undergoing bariatric surgery.

Its role in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is still under investigation, but early studies show promising hepatoprotective effects.

Is Ursodeoxycholic Acid Safe for Kidneys?

Yes, Ursodeoxycholic acid is safe for kidneys when used as prescribed. Its metabolic pathway is primarily hepatic, and it does not impose a significant burden on the kidneys. Since very little of the drug is excreted renally, it poses minimal nephrotoxic risk. Clinical studies have shown that even in patients with mild to moderate renal impairment, UDCA can be safely administered under medical supervision. As with any medication, it is advisable to monitor kidney and liver function during long-term therapy, especially in elderly patients or those with multi-organ comorbidities.

Is Ursodeoxycholic Acid Good for Liver?

Undoubtedly, Ursodeoxycholic acid is highly effective in promoting liver health. It remains one of the most trusted and widely prescribed hepatoprotective agents worldwide. The key liver benefits include:

• Reducing bile acid toxicity, which prevents further damage to liver cells.

• Improving bile flow, which is crucial in cholestatic conditions.

• Protecting liver cells from oxidative stress and apoptosis.

• Reducing inflammation and preventing liver fibrosis.

• Stabilizing liver enzyme levels, thereby improving clinical symptoms and laboratory parameters.

Numerous clinical trials support its use in primary biliary cholangitis, primary sclerosing cholangitis, intrahepatic cholestasis of pregnancy, and other chronic liver disorders.

What are the Benefits of Ursodiol?

Ursodiol (another name for Ursodeoxycholic acid) offers a wide array of medical benefits, making it an essential part of hepatobiliary pharmacotherapy. These include:

• Dissolution of cholesterol gallstones without surgery.

• Improvement of liver enzyme profiles in chronic liver diseases.

• Enhancement of bile flow, reducing intrahepatic cholestasis.

• Prevention of gallstone formation in obese individuals undergoing rapid weight loss or bariatric surgery.

• Reduction of pruritus (itching) in cholestatic liver conditions.

• Protection of liver cells from toxic bile acid-induced damage.

• Improvement in survival rates and delayed progression in chronic liver diseases like primary biliary cholangitis.

It is also explored in secondary biliary cirrhosis, cystic fibrosis-related liver disease, non-alcoholic fatty liver disease, and certain pediatric cholestatic liver diseases.

Is Ursocol Good for Fatty Liver?

Yes, Ursocol (a popular brand of Ursodeoxycholic acid) shows promising results in managing fatty liver disease, particularly non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). While lifestyle modification remains the cornerstone of management, adjunct therapy with Ursocol has been shown to:

• Lower liver enzyme levels (ALT, AST, GGT).

• Reduce hepatic inflammation.

• Improve lipid profiles.

• Decrease fat accumulation in liver cells.

• Protect hepatocytes from oxidative stress.

• Slow down fibrosis progression.

Several clinical studies highlight that combining Ursocol with lifestyle changes, antioxidants, and vitamin E enhances outcomes in patients with fatty liver disease.

Contact Information

Manufacturing Plant:
TAJ PHARMA INDIA LTD.
Plot No.1019, Vill. – Sarigam,
G.I.D.C., Road No. 10, Dist. – Valsad,
Gujarat, India 396155.

Certifications:
WHO-cGMP, GMP, GLP Approved, EU-GMP (upcoming), PIC/S, ISO 9001:2018, SGS

Contact Numbers:
+91-22-2637 4592 (IST)
+91-22-2637 4593
Fax: +91-22-2634 1274
Mobile: +91 84484 44095