Ursodeoxycholic Acid Tablets I.P.

Pacitora Biotech presents Ursotrex-300™, a higher-strength formulation containing Ursodeoxycholic Acid IP 300mg per tablet. Ursodeoxycholic acid (UDCA) is a naturally occurring, hydrophilic bile acid that has become the standard of care for several cholestatic liver disorders and for the non-surgical dissolution of cholesterol gallstones.

Key Benefits:

• Higher Strength Convenience – 300mg tablet reduces pill burden for patients on high doses.

• Gallstone Dissolution – Non-surgical treatment for radiolucent cholesterol gallstones.

• Liver Protection – Reduces toxic bile acids in chronic cholestatic liver diseases.

• Improves Liver Function – Lowers elevated alkaline phosphatase (ALP) and liver enzymes.

• Slows PBC Progression – First-line therapy for primary biliary cholangitis.

FAQs:

1. What is the advantage of Ursotrex-300 over the 150mg strength?
Ursotrex-300 contains 300mg of ursodeoxycholic acid per tablet – twice the strength of the 150mg tablet. This significantly reduces the number of tablets needed daily (e.g., from 7 tablets to 3-4 tablets for a typical PBC patient), improving convenience and compliance.

2. How is Ursotrex-300 dosed for primary biliary cholangitis (PBC)?
The standard dose for PBC is 13–15 mg/kg/day. For a 70kg patient, this equals 910–1050mg daily – which is 3–4 tablets of Ursotrex-300 (taken as 2 tablets in the morning and 1-2 tablets in the evening with food).

3. How long does it take for Ursotrex-300 to dissolve gallstones?
Gallstone dissolution typically takes 6 to 24 months, depending on stone size, number, and composition. Ultrasound monitoring is performed every 6 months to check progress. Once stones dissolve completely, treatment is usually continued for another 1–3 months.

4. Can Ursotrex-300 be taken during pregnancy?
Yes, Ursotrex-300 is generally considered safe during pregnancy (FDA Category B). It is actually the standard treatment for intrahepatic cholestasis of pregnancy (ICP), a condition causing severe itching and liver dysfunction. Always consult your doctor before use.