As a naturally occurring bile acid, UDCA is a cornerstone in the management of cholesterol gallstones that do not require surgery, and is the only FDA-approved therapy for Primary Biliary Cholangitis (PBC), a chronic liver disease. It also plays a crucial role in managing liver and biliary disorders associated with Cystic Fibrosis in children and adolescents. UDIBIO 300 works by improving bile flow, reducing cholesterol saturation in bile, and protecting liver cells from damage caused by toxic bile acids, thereby supporting liver function and potentially slowing disease progression.

Why UDIBIO 300 TABLETS is a Key Treatment for Bile-Related Conditions:

UDIBIO 300 TABLETS harnesses the unique properties of Ursodeoxycholic Acid to provide multifaceted therapeutic benefits:

• Dissolves Cholesterol Gallstones: UDCA actively reduces the cholesterol content of bile and helps to dissolve non-calcified cholesterol gallstones. It works by decreasing the amount of cholesterol produced by the liver and inhibiting its absorption from the intestine, making the bile less saturated with cholesterol and more conducive to dissolving existing stones.

• Treats Primary Biliary Cholangitis (PBC): UDIBIO 300 is the primary treatment for PBC, an autoimmune disease that gradually damages the bile ducts in the liver. It improves bile flow, reduces the accumulation of toxic bile acids in the liver, protects liver cells from injury, and helps to improve liver enzyme levels, potentially delaying the progression of liver fibrosis and cirrhosis, especially when initiated in early stages.

• Manages Liver Disease in Cystic Fibrosis: In children and adolescents with cystic fibrosis, UDCA helps to improve liver function and bile flow, addressing the specific liver and biliary complications associated with this genetic disorder.

• Hepatoprotective Action: UDCA is a hydrophilic (water-loving) bile acid that replaces more toxic, hydrophobic bile acids in the bile acid pool. This helps to protect liver cells (hepatocytes) and bile duct cells (cholangiocytes) from the damaging effects of accumulated bile, exerting anti-inflammatory and immunomodulatory effects.

• Improves Bile Flow: By promoting the secretion of bile acids and increasing the fluidity of bile, UDIBIO 300 helps to improve overall bile flow, which is crucial for digestive health and the removal of waste products from the liver.

Key Benefits of UDIBIO 300 TABLETS at a Glance:

• Gallstone Dissolution: Effectively dissolves certain types of cholesterol gallstones.

• PBC Treatment: Approved and primary therapy for Primary Biliary Cholangitis.

• Cystic Fibrosis Liver Management: Addresses liver complications in cystic fibrosis.

• Hepatoprotective: Protects liver cells from bile acid-induced damage.

• Improves Bile Flow: Enhances the body's natural detoxification process.

• Helps Improve Liver Function Tests: Often leads to better liver enzyme levels.

Important Usage Instructions for UDIBIO 300 TABLETS:

Always take UDIBIO 300 TABLETS exactly as prescribed by your doctor. The dosage and duration of treatment will depend on your specific condition, body weight, and response to therapy. Long-term treatment (several months to years) is often necessary for gallstone dissolution and chronic liver conditions like PBC.

• Take UDIBIO 300 TABLETS with food, often after a meal, with a glass of water or milk, to enhance absorption.

• Swallow the tablet whole; do not chew, crush, or break it, unless specifically instructed by your doctor (some formulations may be scored for breaking).

• Your doctor may prescribe multiple doses throughout the day (e.g., 2-3 times daily) for some conditions, with the last dose often taken at bedtime. For gallstone dissolution, it may sometimes be prescribed as a single daily dose at night.

• Do not stop taking this medication suddenly without consulting your doctor, even if your symptoms improve.

• Regular monitoring of liver function (blood tests), including bilirubin levels, is crucial, especially during the initial months of treatment for PBC, and periodically thereafter.

• Inform your doctor about any pre-existing medical conditions, especially:

  • Complete blockage of a bile duct or inflammation of the gallbladder/bile ducts.

  • Severe liver disease (decompensated cirrhosis).

  • Frequent cramp-like pain in the upper abdomen (biliary colic).

  • Calcified gallstones (UDCA is not effective for these).

  • Inflammatory bowel disease.

  • Pregnancy or breastfeeding.

• Drug Interactions: Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements, particularly:

  • Antacids containing aluminum hydroxide, cholestyramine, colestipol, or colesevelam (bile acid sequestrants): These can bind to UDCA and reduce its absorption. Take UDIBIO 300 at least 2 hours before or 2 hours after these medications.

  • Estrogen-containing oral contraceptives or hormone replacement therapy: These can increase cholesterol saturation in bile and may reduce the effectiveness of UDCA for gallstone dissolution. Non-hormonal contraception or low-estrogen pills are generally preferred during treatment.

  • Fibrates (e.g., clofibrate, gemfibrozil, fenofibrate): These can also increase cholesterol secretion into bile.

  • Cyclosporine, Nitrendipine, Dapsone: UDCA may affect the absorption or metabolism of these drugs.

• Potential Side Effects: While generally well-tolerated, common side effects may include:

  • Diarrhea (most common, especially with higher doses).

  • Abdominal pain or discomfort.

  • Nausea.

  • Hair loss.

  • Itching, rash.

  • Pasty stools.

  • Rarely, calcification of existing gallstones or worsening of liver function in advanced liver disease.

• If you experience persistent or severe side effects, especially severe diarrhea, or signs of worsening liver function (e.g., yellowing of skin/eyes), seek immediate medical attention.

• Maintain a healthy, low-cholesterol diet and regular exercise as advised by your doctor. Avoid excessive alcohol consumption.

• Keep out of reach of children. Store in a cool, dry place away from direct sunlight.

Understanding How Ursodeoxycholic Acid (UDCA) in UDIBIO 300 Works:

Ursodeoxycholic Acid is a secondary bile acid that, when administered orally, becomes a significant component of the body's bile acid pool. Its therapeutic effects are attributed to several mechanisms:

1. Cholesterol Solubilization and Reduction: UDCA reduces the secretion of cholesterol into bile and inhibits its intestinal absorption. This changes the composition of bile, making it less saturated with cholesterol and more capable of solubilizing cholesterol, which is crucial for dissolving cholesterol gallstones.

2. Displacement of Toxic Bile Acids: UDCA is more hydrophilic (water-soluble) and less toxic than the body's naturally occurring hydrophobic bile acids. By increasing the proportion of UDCA in the bile acid pool, it competitively displaces and reduces the concentration of these more harmful bile acids, thereby protecting liver cells from their damaging effects.

3. Hepatoprotection and Immunomodulation: UDCA stabilizes liver cell membranes, protects mitochondria from oxidative stress, and inhibits apoptosis (programmed cell death) induced by toxic bile acids. It also exerts immunomodulatory effects, which are particularly relevant in autoimmune liver diseases like PBC, by influencing immune responses and reducing inflammation.

4. Choleretic Effect: UDCA promotes increased bile flow by stimulating the secretion of bile acids and bicarbonate into the bile ducts. This "flushing" action helps to clear accumulated toxic substances from the liver.

Through these combined actions, UDIBIO 300 (Ursodeoxycholic Acid 300mg) effectively targets the underlying causes and symptoms of cholesterol gallstones and cholestatic liver diseases, offering significant therapeutic benefits.