Urso 300 mg

Description

Indications
Urso is indicated 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 medicine under the supervision of a registered healthcare professional.

Description
Urso is a medication that helps reduce the cholesterol content in bile, aiding in the dissolution of cholesterol gallstones. It works by lowering the cholesterol saturation in bile, which allows gradual solubilization of the cholesterol gallstones. By decreasing cholesterol secretion into the bile, Urso also increases the bile acid secretion rate, without lowering the phospholipid levels.

Pharmacology
Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid that is widely used to manage various hepatobiliary conditions. Its therapeutic action is primarily due to its ability to decrease cholesterol secretion in bile. It works through multiple mechanisms: reducing cholesterol absorption in the intestines, inhibiting cholesterol synthesis in the liver, and not interfering with bile acid synthesis.

As a result, Ursodeoxycholic Acid alters the composition of bile, transforming it from being supersaturated with cholesterol to a more unsaturated state. This change promotes the formation of liquid cholesterol crystal complexes, facilitating the removal of cholesterol from the gallbladder and its eventual excretion through the intestine.

In liver conditions, Ursodeoxycholic Acid has several protective effects:

• It safeguards cholangiocytes (bile duct cells) from the toxic effects of hydrophobic bile acids.
• It stimulates hepatobiliary secretion.
• It protects hepatocytes (liver cells) from bile acid-induced cell death (apoptosis).

Ursodeoxycholic Acid is absorbed in the upper small intestine, with peak serum concentration occurring between 30 to 150 minutes after ingestion. The absorption rate ranges from 60% to 80%. Once absorbed, it enters the portal vein and is extracted by the liver, where it is conjugated with either glycine or taurine. The conjugated bile acid is then secreted into the hepatic bile ducts. Only small amounts of Ursodeoxycholic Acid are detected in circulation, and trace amounts are excreted through urine. The biological half-life of Ursodeoxycholic Acid is between 3.5 to 5.8 days.

Dosage & Administration

• Dissolution of Gallstones: 8-12 mg/kg/day, either as a single dose at night or divided doses.
• Primary Biliary Cirrhosis: 10-15 mg/kg/day, in 2-4 divided doses.
• Acute Viral Hepatitis: 600 mg/day.
• Alcoholic Fatty Liver: 300 mg/day.
• Primary Sclerosing Cholangitis: 25-30 mg/kg/day.
• Non-Alcoholic Steatohepatitis & Gallstone Dissolution: 13-15 mg/kg/day.

Use this medicine as directed by a registered healthcare professional.

Interaction
Urso should not be used with medications that increase bile cholesterol levels, such as oestrogenic hormones. Avoid using Urso concurrently with bile acid-binding agents, including antacids, charcoal, and cholestyramine, as these may reduce the effectiveness of the treatment.

Contraindications
Urso should not be used in patients with:

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

Side Effects
Common side effects include:

• Nausea
• Vomiting
• Diarrhea
• Gallstone opacity (visibility on imaging tests)
• Itching (pruritus)

Pregnancy & Lactation

• Pregnancy: Category B. No harmful effects have been reported during pregnancy, and it has been used effectively for the treatment of cholestasis during the third trimester without adverse effects.
• Lactation: There are no known issues with breastfeeding while using Urso.

Precautions & Warnings
Caution is advised when using Urso in individuals with existing liver disease.

Therapeutic Class

• Anti-gallstone drugs: Bile acids

Storage Conditions
Store below 25°C, in a dry place, protected from light. Keep the medication out of reach of children.