Ursolic 150 mg

Description

Indications

Ursolic is prescribed for the treatment of the following conditions:

• 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 is used to lower cholesterol saturation in bile, aiding in the dissolution of gallstones. By decreasing cholesterol levels in bile, it facilitates the gradual breakdown of cholesterol-based gallstones. Additionally, Ursolic enhances bile acid secretion while reducing cholesterol secretion, maintaining phospholipid levels.

Pharmacology

Ursodeoxycholic Acid (UDCA), the active component in Ursolic, is a naturally occurring bile acid that treats various hepatobiliary disorders by decreasing cholesterol secretion in bile. Its therapeutic effects are achieved through several mechanisms:

• Reducing intestinal cholesterol absorption
• Suppressing hepatic cholesterol synthesis
• Altering bile composition from supersaturated to unsaturated
• Facilitating the formation of liquid cholesterol crystal complexes, enhancing cholesterol removal from the gallbladder into the intestine for excretion

Ursodeoxycholic Acid also plays a significant role in improving cholestatic liver diseases by:

• Protecting bile duct cells (cholangiocytes) from the toxic effects of hydrophobic bile acids
• Enhancing bile flow from the liver (hepatobiliary secretion)
• Shielding liver cells (hepatocytes) from bile acid-induced apoptosis

Following oral administration, Ursodeoxycholic Acid is absorbed in the upper intestine, reaching peak serum levels within 30 to 150 minutes. Absorption rates range between 60-80%. Once in the liver, it is conjugated with amino acids (glycine or taurine) and secreted into bile. Only small amounts enter the systemic circulation or are excreted in 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 nighttime dose or divided throughout the day.
• Primary Biliary Cirrhosis: 10-15 mg/kg/day in 2-4 divided 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 taken with medications that increase bile cholesterol levels, such as estrogen-containing hormones. Additionally, concurrent use of bile-acid binding agents (e.g., certain antacids, activated charcoal, and cholestyramine) should be avoided, as they may reduce the effectiveness of Ursolic.

Contraindications

Ursolic is not recommended for individuals with:

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

Side Effects

Possible 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 to manage pregnancy-related cholestasis in the last trimester.
• Lactation: No known risks have been documented 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.