URSODELIC Ursodeoxycholic Acid 300mg - 1 Tablet

Indications / Uses

URSODELIC Ursodeoxycholic Acid 300mg is used for dissolving cholesterol-rich gallstones in patients who have a functioning gallbladder where the stones are non-calcified and do not show up on X-rays. It is also indicated for the management of primary biliary cirrhosis (PBC), which is a chronic liver condition. This medication works by reducing the cholesterol content of bile, which aids in the gradual dissolution of stones and helps improve bile flow in liver conditions.

Formulation / Ingredients

URSODELIC Ursodeoxycholic Acid 300mg contains: Ursodeoxycholic Acid 300mg

Side Effects

URSODELIC Ursodeoxycholic Acid 300mg common side effects include: gastrointestinal disturbances such as nausea, vomiting, stomach pain, and diarrhea. Diarrhea is reported to be the most frequent adverse reaction, particularly at the beginning of treatment or with higher doses. Other less common effects may involve dizziness, heartburn, and skin reactions like itching or rash. In very rare instances, particularly in patients with advanced liver disease, decompensation of the existing condition has been reported.

Directions and Dosage

• Dosage for Adults (18+ years) for Gallstone Dissolution: Dosage is typically between 8 to 10 mg per kg of body weight daily, divided into 2 or 3 doses. The total daily dose may be divided unequally with the larger portion taken before bedtime. Treatment duration is generally 6 to 24 months.
• Dosage for Adults (18+ years) for Primary Biliary Cirrhosis (PBC): Dosage is typically between 10 to 15 mg per kg of body weight daily, divided into 2 to 4 doses. For the first 3 months, doses may be divided, then the entire daily dose may be taken once in the evening.

Obese patients may require up to 15 mg/kg daily. For dissolving gallstones, continued treatment for 3 to 4 months after radiological stone disappearance is often necessary. Dosage for children and adolescents must be determined on an individual basis, often starting at 20 mg/kg/day for conditions like cystic fibrosis.

Contraindications

Do not use if there is a known allergy to the main ingredient or any other bile acids. Avoid use in cases of acute inflammation of the gallbladder or bile ducts, complete obstruction of the biliary tract, or when gallstones are calcified (radio-opaque). It should also not be used in patients with an impaired contractility of the gallbladder, acute cholecystitis, or severe pancreatic disease.

Use in Pregnancy and Lactation

This product may be used for a specific liver condition that occurs during pregnancy. If used while breastfeeding, there are no sufficient studies to determine infant risk, though only minimal amounts are expected to pass into the system.

Special Precautions

• Liver function parameters must be checked regularly, especially during the initial months of treatment.
• Temporary worsening of symptoms, like itching, may occur at the start of treatment for certain liver conditions.
• In cases of diarrhea, the daily quantity consumed may need to be reduced.
• Use with caution in the elderly, as general physical functions tend to decline with age.

Is it safe to take it with other medications?

The absorption can be reduced by aluminum-containing antacids, cholestyramine, or colestipol, which should not be administered at the same time. Medications that increase cholesterol in the bile, such as oral contraceptives containing estrogen, may reduce its effectiveness.

How should I store it?

Store at a temperature not exceeding 30°C. Keep the tablets in their original packaging, away from heat and moisture.

Used For

Gallstone Dissolution, PBC

Age

Adults & up