Ursolic 300 mg

Description

Indications

Ursolic is prescribed for the treatment of various liver and gallbladder conditions, including:

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Biliary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones
• Non-Alcoholic Steatohepatitis (NASH)

Use this medication only as directed by a registered physician.

Description

Ursolic helps reduce the cholesterol saturation in bile, aiding in the dissolution of gallstones. By lowering cholesterol levels in bile, it facilitates the gradual breakdown of cholesterol-based gallstones. Additionally, Ursolic decreases cholesterol secretion while increasing bile acid production, without significantly affecting phospholipid levels.

Pharmacology

Ursodeoxycholic Acid (UDCA), the active ingredient in Ursolic, is a naturally occurring bile acid that treats various hepatobiliary disorders by reducing cholesterol secretion in bile. Its mechanism of action includes:

• Decreasing intestinal cholesterol absorption
• Suppressing hepatic cholesterol synthesis
• Modifying bile composition from supersaturated to unsaturated
• Promoting cholesterol elimination via liquid cholesterol crystal complexes

Furthermore, Ursodeoxycholic Acid enhances liver function in cholestatic conditions by:

• Protecting bile duct cells (cholangiocytes) from toxic bile acids
• Stimulating bile flow from the liver (hepatobiliary secretion)
• Shielding liver cells (hepatocytes) from bile acid-induced cell death (apoptosis)

After oral administration, Ursodeoxycholic Acid is absorbed in the upper intestine, with peak serum levels occurring within 30 to 150 minutes. Absorption rates range from 60-80%. Once absorbed, it enters the liver via the portal vein, where it is conjugated with amino acids (glycine or taurine) and then excreted into bile. Only small amounts circulate in the bloodstream or are eliminated through urine. The biological half-life ranges from 3.5 to 5.8 days.

Dosage & Administration

• Gallstone Dissolution: 8-12 mg/kg/day, taken as a single dose at bedtime or divided throughout the day.
• Primary Biliary Cirrhosis: 10-15 mg/kg/day, divided into 2-4 doses.
• Acute Viral Hepatitis: 600 mg per day.
• Alcoholic Fatty Liver: 300 mg per day.
• Primary Sclerosing Cholangitis: 25-30 mg/kg/day.
• Dissolution of Gallstones & NASH: 13-15 mg/kg/day.

Use this medication only as directed by a registered physician.

Drug Interactions

Ursolic should not be used alongside medications that increase bile cholesterol levels, such as estrogen-containing hormones. Additionally, bile-acid binding agents, including certain antacids, activated charcoal, and cholestyramine, may reduce Ursolic’s effectiveness and should be avoided during treatment.

Contraindications

Ursolic is not recommended for patients with:

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

Side Effects

Potential side effects include:

• Nausea
• Vomiting
• Diarrhea
• Gallstone calcification
• Itching (pruritus)

Pregnancy & Lactation

• Pregnancy: Classified as Category B—no evidence of harm has been reported. It has been safely used in treating pregnancy-related cholestasis during the last trimester.
• Lactation: No documented risks during breastfeeding.

Precautions & Warnings

• Should be used with caution in patients with liver disease.

Therapeutic Class

• Anti-gallstone drugs (Bile Acids)

Storage Conditions

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