Ursolic 300 Tablet 1 Strip

✔️ Description: Ursodeoxycholic Acid

Ursolic acid reduces cholesterol saturation in bile, thereby facilitating the gradual dissolution of cholesterol gallstones. It works by lowering cholesterol secretion into bile and increasing bile acid secretion without reducing phospholipid concentration. This change in bile composition allows cholesterol stones to slowly dissolve and prevents further stone formation.

Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used in the treatment of various hepatobiliary disorders. Its therapeutic action is achieved primarily by decreasing biliary cholesterol secretion through multiple mechanisms:

Reduces intestinal absorption of cholesterol

Suppresses hepatic cholesterol synthesis

Maintains bile acid synthesis

As a result, bile composition shifts from cholesterol-supersaturated to unsaturated. UDCA also promotes the formation of liquid cholesterol crystal complexes, enhancing cholesterol removal from the gallbladder into the intestine for elimination.

In cholestatic liver diseases, Ursodeoxycholic Acid:

Protects cholangiocytes from the toxic effects of hydrophobic bile acids

Stimulates hepatobiliary secretion

Protects hepatocytes from bile acid-induced apoptosis

Pharmacokinetics:
Ursodeoxycholic Acid is well absorbed from the upper intestine, with peak plasma concentrations occurring within 30–150 minutes. Approximately 60–80% of the drug is absorbed. After absorption, it is taken up by the liver, conjugated with glycine or taurine, and secreted into bile. Only minimal amounts enter systemic circulation or are excreted in urine. The biological half-life ranges from 3.5 to 5.8 days.

✔️ Side Effects

• Nausea
• Vomiting
• Diarrhea
• Gallstone opacification
• Pruritus (itching)

✔️ Dosage & Administration

• Gallstone dissolution: 8–12 mg/kg/day (single bedtime dose or divided doses)
• Primary biliary cirrhosis (PBC): 10–15 mg/kg/day in 2–4 divided doses
• Acute viral hepatitis: 600 mg/day
• Alcoholic fatty liver disease: 300 mg/day
• Primary sclerosing cholangitis (PSC): 25–30 mg/kg/day
• Gallstones & NASH: 13–15 mg/kg/day

✔️ Interaction

Concomitant use with estrogenic hormones should be avoided, as they increase bile cholesterol levels.

Bile acid–binding agents such as antacids, activated charcoal, cholestyramine, or colestipol may reduce the effectiveness of Ursolic and should be avoided or taken at different times.

✔️ Contraindications

• Non-functioning gallbladder
• Calcified or pigmented gallstones
• Inflammatory bowel disease

✔️ Pregnancy & Lactation

Pregnancy category: B
No evidence of fetal harm has been reported. Ursolic has been safely used in cholestasis of pregnancy during the third trimester.

Breastfeeding: No adverse effects have been documented in nursing infants.

✔️ Precautions & Warnings

• Use with caution in patients with underlying liver disease
• Regular monitoring of liver function is advised during long-term therapy

✔️ Storage:

Store below 25°C.
Protect from light and moisture.
Keep out of reach of children.