UDCHOLIC SR 450

Ursodeoxycholic Acid Tablet is a bile acid that dissolves cholesterol gallstones, safeguards liver cells, and treats chronic conditions such as PBC It works by changing the composition of bile — reducing cholesterol saturation and protecting liver cells — which helps prevent stone formation and slows liver disease progression. It is available in multiple strengths (150mg, 300mg, 450mg) and is generally taken with food, once or in divided doses, for a duration ranging from several months to long-term ongoing therapy depending on the condition. Common side effects include diarrhea, nausea, and mild stomach upset. 

What Is Ursodeoxycholic Acid Tablet?

Ursodeoxycholic Acid (UDCA) Tablet contains a synthetic version of a naturally occurring bile acid produced in small quantities by the human liver. Unlike more toxic bile acids that can injure liver cells when present in excess, ursodeoxycholic acid is hepatoprotective — it shields liver tissue while improving bile flow and composition.

It is manufactured in multiple tablet strengths to suit different clinical needs, from lower titratable doses to higher once-daily convenience doses, under WHO-GMP and ISO-certified manufacturing standards.

Key Clinical Indications

Condition	How Ursodeoxycholic Acid Tablet Helps
Cholesterol gallstones (small, radiolucent)	Dissolves stones by lowering cholesterol saturation in bile
Primary Biliary Cholangitis (PBC)	Slows disease progression, improves liver enzyme levels
Non-alcoholic fatty liver disease (adjunct)	Helps reduce elevated liver enzymes as supportive therapy
Post-bariatric surgery gallstone prevention	Prophylactic use to reduce new gallstone formation
Biliary reflux gastritis	Reduces bile-related irritation of the stomach lining

Mechanism of Action

1. Cholesterol desaturation – Lowers the proportion of cholesterol in bile relative to bile acids and phospholipids, discouraging crystal formation and allowing small stones to dissolve gradually.
2. Cytoprotection – Replaces more harmful, hydrophobic bile acids in the bile acid pool with a gentler, hydrophilic molecule, reducing damage to liver cell membranes.
3. Immunomodulation – In PBC, it is thought to reduce inflammatory signaling on bile duct cells, slowing autoimmune-related damage.
4. Choleretic effect – Stimulates bile flow, helping the liver clear potentially harmful substances more efficiently.

Dosage Guidelines

Dosage of ursodeoxycholic acid tablets is individualized based on body weight, the condition being treated, and the strength prescribed (150mg, 300mg, or 450mg). General patterns include:

• Gallstone dissolution: Weight-based dosing, taken in divided doses with meals, continued for several months with periodic ultrasound monitoring.
• Primary Biliary Cholangitis: Weight-based daily dose, taken with food, as long-term maintenance therapy.
• Liver support / adjunct use: Lower maintenance doses as directed by the physician.

Tablets are best taken with food to aid absorption and minimize gastrointestinal discomfort. Doses should not be doubled if a dose is missed.

Key Benefits

• Non-surgical option for dissolving small cholesterol gallstones
• Slows progression of chronic cholestatic liver disease
• Generally well tolerated for long-term therapy
• May help improve liver enzyme markers in appropriate candidates
• Available across multiple strengths for flexible, physician-guided dosing

Side Effects

Common (mild):

• Diarrhea or loose stools
• Nausea
• Mild abdominal discomfort or bloating

Less common:

• Constipation
• Headache
• Skin itching or mild rash

Rare but requiring medical attention:

• Signs of worsening liver function (yellowing of skin/eyes, dark urine, severe abdominal pain)
• Severe allergic reaction (swelling, difficulty breathing, hives)

Substitutes / Comparable Bile Acid Therapies

Composition	Typical Use Case	Notes
Ursodeoxycholic Acid 150mg	Lower/titratable dosing, combination regimens	Lower strength
Ursodeoxycholic Acid 300mg	Standard adult maintenance dosing	Most commonly prescribed strength
Ursodeoxycholic Acid 450mg	Higher-weight patients, once-daily convenience	Fewer daily tablets needed
Obeticholic acid	Second-line PBC therapy	Used when UDCA response is inadequate

Precautions

• Not recommended for calcified gallstones, a non-functioning gallbladder on imaging, or acute cholecystitis.
• Use cautiously in patients with severe liver impairment; regular liver function monitoring is advised.
• Inform your doctor of all other medications, as certain drugs (e.g., cholesterol-binding resins, some antacids) can reduce absorption if taken too close together.
• Pregnancy and breastfeeding: use only if clearly advised by a physician after weighing risks and benefits.
• Periodic gallbladder ultrasound monitoring is typically recommended during gallstone dissolution therapy.

Conclusion

Ursodeoxycholic Acid Tablet is a well-established bile acid therapy used to dissolve small cholesterol gallstones and manage chronic cholestatic liver conditions such as primary biliary cholangitis. Its combined action of reducing cholesterol saturation in bile and protecting liver cells makes it valuable for long-term, non-surgical disease management. While generally well tolerated, side effects and treatment duration should always be discussed with a qualified doctor, and regular monitoring is essential for the best outcomes. 

Frequently Asked Questions 

1. What is ursodeoxycholic acid used to treat?

It is used to dissolve small cholesterol gallstones and to treat chronic liver conditions such as primary biliary cholangitis by improving bile flow and protecting liver cells.

2. Is ursodeoxycholic acid Tablet good for fatty liver?

It is sometimes used as an adjunct therapy to help lower elevated liver enzymes in fatty liver disease, though it is not a standalone first-line treatment; a doctor's evaluation is needed to confirm suitability.

3. Can a normal person take ursodeoxycholic acid?

No. It is a prescription-only Schedule H medicine meant for patients with a diagnosed condition like gallstones or liver disease, not for general or preventive use without medical supervision.

4. How long can I use ursodeoxycholic acid?

Duration varies by condition — gallstone dissolution may take several months to over a year, while chronic conditions like PBC often require long-term therapy under medical supervision.

5. What are the major side effects of ursodeoxycholic acid?

The most common side effects are diarrhea, nausea, and mild abdominal discomfort. Rare but serious effects include signs of worsening liver function or allergic reactions requiring immediate medical attention.

6. What foods should I avoid when taking ursodeoxycholic acid?

There's no strict food ban, but very high-fat, greasy meals may worsen digestive side effects. Patients with gallstones are often advised to keep fat intake moderate and consistent.

7. When to take ursodeoxycholic acid tablets?

It is generally taken with meals or shortly after eating to improve absorption and reduce stomach upset, following the exact schedule prescribed by your doctor.

8. Can ursodeoxycholic acid dissolve all types of gallstones?

No. It works best on small, cholesterol-based (radiolucent) stones. Calcified or large stones typically do not respond and may need other treatment approaches.

9. Is ursodeoxycholic acid safe for long-term use?

It is generally considered safe for long-term use under medical supervision, with periodic liver function monitoring recommended.

10. Can ursodeoxycholic acid be taken during pregnancy?

It should only be used in pregnancy if specifically advised by a doctor, as risks and benefits must be carefully weighed for each case.

11. Does ursodeoxycholic acid interact with other medications?

Yes, certain drugs like cholesterol-binding resins and some antacids can reduce its absorption. Always inform your doctor about all medications you take.

12. What happens if I miss a dose of ursodeoxycholic acid?

Take the missed dose as soon as you remember, but skip it if it's almost time for the next dose. Do not double the dose.

13. Can ursodeoxycholic acid be stopped suddenly?

It should not be stopped abruptly without consulting your doctor, especially in chronic liver conditions, as this may affect disease management.

14. Does ursodeoxycholic acid cause weight gain or loss?

It is not typically associated with significant weight changes; digestive side effects like diarrhea could cause minor, temporary fluctuations in some patients.

15. Can ursodeoxycholic acid be taken with alcohol?

Alcohol can add strain to the liver, so it is generally advisable to limit or avoid alcohol while on this therapy, especially in liver disease patients.

16. How is treatment success monitored while on ursodeoxycholic acid?

Doctors typically monitor progress through periodic liver function tests and, for gallstones, ultrasound imaging to check stone size reduction over time.

17. Is ursodeoxycholic acid tablet available without a prescription?

No. This is a Schedule H prescription-only medication and should only be used under the guidance of a qualified doctor.

Product Information

Brand name: UDCHOLIC SR 450 (STERIS HEALTHCARE PVT LTD)

Composition Name: Ursodeoxycholic Acid (450 mg)

Pack size: Strip of 10 tablets

Marketed By: Steris Healthcare Pvt Ltd

Regulatory standard: WHO-GMP certified

Schedule: Valid Prescription Required (prescription only) please create in this manner.