Ursocol 150 mg

Description

Indications

Ursocol 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

Ursocol helps reduce cholesterol saturation in bile, facilitating the gradual dissolution of gallstones. By decreasing the cholesterol content in bile, this medication promotes the breakdown of cholesterol gallstones. Additionally, it increases the secretion of bile acids while maintaining phospholipid levels, thereby supporting overall bile composition.

Pharmacology

Ursodeoxycholic Acid (UDCA), the active ingredient in Ursocol, is a naturally occurring bile acid that plays a crucial role in managing hepatobiliary disorders by lowering cholesterol secretion in bile. It works through several mechanisms, including:

• Reducing cholesterol absorption in the intestines
• Suppressing cholesterol synthesis in the liver
• Modifying bile composition from a supersaturated to an unsaturated state
• Encouraging the formation of liquid cholesterol crystal complexes, aiding cholesterol removal from the gallbladder and facilitating its excretion through the intestines

Ursodeoxycholic Acid is also beneficial in cholestatic liver diseases as it:

• Protects bile duct cells (cholangiocytes) from the harmful effects of hydrophobic bile acids
• Enhances bile secretion from the liver (hepatobiliary secretion)
• Shields liver cells (hepatocytes) from bile acid-induced apoptosis

After oral administration, Ursodeoxycholic Acid is efficiently absorbed in the upper intestine, reaching peak serum levels within 30 to 150 minutes. The absorption rate ranges between 60-80%. Once absorbed, it enters the portal vein and is taken up by the liver, where it undergoes conjugation with amino acids (glycine or taurine) before being secreted into the bile. Only small amounts enter systemic circulation, with minimal excretion via urine. The biological half-life of Ursodeoxycholic Acid is approximately 3.5 to 5.8 days.

Dosage & Administration

• Gallstone Dissolution: 8-12 mg/kg/day, taken as a single nighttime dose or divided into multiple doses.
• 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

Ursocol should not be used in combination with medications that increase bile cholesterol levels, such as estrogen-containing hormones. Additionally, the concurrent use of bile acid-binding agents, including certain antacids, activated charcoal, and cholestyramine, should be avoided, as they may reduce the effectiveness of Ursocol.

Contraindications

Ursocol is not recommended for patients with:

• A non-functioning gallbladder
• Calcified or pigmented gallstones
• Inflammatory bowel disease

Side Effects

Commonly reported side effects may include:

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

Pregnancy & Lactation

• Pregnancy: Categorized as Pregnancy Class B. No harmful effects have been reported, and it has been successfully used to treat cholestasis of pregnancy in the last trimester without adverse outcomes.
• Lactation: No known risks have been documented regarding 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.