Ursocol 150mg Tab

URSOCOL 150MG TAB by SUN PHARMA LABORATORIES LTD.

Name

Brand Name: Ursocol 150mg Tablet Common Name: Ursodeoxycholic Acid (UDCA)

Composition

Each tablet contains Ursodeoxycholic Acid 150 mg as the active ingredient.

Uses

Ursocol 150mg Tablet is primarily used for the management and treatment of various hepatobiliary disorders. It is indicated for:

• Dissolution of cholesterol-rich gallstones and prevention of gallstones in patients undergoing rapid weight loss.
• Treatment of Primary Biliary Cirrhosis (PBC), an autoimmune liver disease.
• Management of other liver-related disorders such as cholestasis (jaundice), viral hepatitis, alcoholic fatty liver, Primary Sclerosing Cholangitis (PSC), and Non-Alcoholic Steato Hepatitis (NASH).
• Addressing liver dysfunction associated with cystic fibrosis in children above 6 years.

Dosage and Administration

Ursocol 150mg Tablet should be swallowed whole with a glass of water, preferably after a meal. Taking it with milk can also be recommended. The dosage and duration of treatment depend on the specific medical condition and the patient's body weight, as determined by a physician.

• For Dissolution of Gallstones: Typically 8-12 mg/kg/day, either as a single nighttime dose or in divided doses.
• For Primary Biliary Cirrhosis (PBC): Usually 10-15 mg/kg/day in 2-4 divided doses.
• Other conditions: Doses can vary, for example, 600 mg/day for acute viral hepatitis and 300 mg/day for alcoholic fatty liver. It is crucial to take the medicine regularly for the prescribed duration, which may extend for several months or longer, even if symptoms disappear.

Side Effects

Commonly reported side effects include:

• Nausea, vomiting, and diarrhea
• Abdominal pain or discomfort
• Gallstone opacification (hardening of gallstones)
• Pruritus (itching)
• Rash
• Hair loss or thinning
• Indigestion, dizziness, and weakness If diarrhea is persistent or severe, the dose may need to be reduced or discontinued.

Precautions

• Contraindications: Do not use if allergic to ursodeoxycholic acid or any other ingredients. It is contraindicated in patients with stomach or intestinal ulcers, recent intestinal surgery, non-functioning gallbladder, calcified or pigmented gallstones, inflammatory bowel disease, or severe liver problems.
• Drug Interactions:
  • Avoid concomitant use with oestrogenic hormones, as they can increase bile cholesterol.
  • Bile-acid binding drugs (e.g., antacids containing aluminum hydroxide, charcoal, cholestyramine, colestipol) can reduce the effectiveness of Ursocol. A gap of at least 2 hours should be maintained between administrations.
  • Avoid oral contraceptives, other estrogenic hormones, and cholesterol-lowering agents like clofibrate, as they may increase the risk of gallstone formation.
• Special Warnings:
  • Use with caution in patients with existing liver disease; regular monitoring of liver function and bilirubin levels may be required.
  • Women of childbearing age should use non-hormonal contraceptive methods or low-estrogen oral contraceptive pills.
  • Avoid alcohol consumption, as it can potentially harm the liver and interfere with the medication's effectiveness.
  • Gallstone dissolution may take several months of continuous treatment.
  • Limited information is available for use in kidney disease.
  • The safety and efficacy in children below 18 years are not clinically established, though it may be prescribed for children above 6 years for specific conditions like cystic fibrosis-related liver diseases.

Storage

Store Ursocol 150mg Tablet below 25°C or 30°C. Protect from light and moisture. Keep the medicine out of the sight and reach of children.

URSOCOL 150MG TAB (Ursodeoxycholic Acid) is a medication primarily used to treat various liver and gallbladder conditions. Here are some frequently asked questions about this medicine:

What is URSOCOL 150MG TAB used for?

URSOCOL 150MG TAB is primarily used to dissolve certain types of gallstones that are rich in cholesterol and to prevent their formation. It is also prescribed for managing primary biliary cholangitis (PBC), a chronic liver disease, and other liver-related disorders such as cirrhosis, sclerosing cholangitis, and liver dysfunction associated with cystic fibrosis. It can also be used to prevent gallstones in individuals who are rapidly losing weight.

How does URSOCOL 150MG TAB work?

URSOCOL 150MG TAB contains ursodeoxycholic acid (UDCA), which is a naturally occurring bile acid. It works by reducing the amount of cholesterol absorbed from the intestine and decreasing the cholesterol secreted by the liver into the bile, thereby lowering cholesterol saturation in the bile. This action helps to gradually dissolve cholesterol-based gallstones. Additionally, UDCA improves bile flow, promotes the secretion of bile acids, and protects liver cells from damage caused by more toxic bile acids.

What is the usual dosage for URSOCOL 150MG TAB?

The dosage of URSOCOL 150MG TAB varies depending on the condition being treated and the patient's body weight, as determined by a doctor. For the dissolution of gallstones, a common dose is 8-12 mg/kg per day, which may be taken as a single dose at night or divided throughout the day. For primary biliary cholangitis (PBC), the usual dosage is 10-15 mg/kg per day, divided into 2-4 doses. It is generally advised to take this medicine with food, ideally after a meal, and sometimes with a glass of milk or water. The last dose is often recommended at bedtime.

What are the possible side effects of URSOCOL 150MG TAB?

Common side effects associated with URSOCOL 150MG TAB include abdominal pain or discomfort, diarrhea, nausea, temporary hair loss, itching, and skin rashes. Most of these side effects are temporary and often resolve as the body adjusts to the medication. If diarrhea occurs and is persistent or bothersome, a doctor may suggest reducing the dose.

Is URSOCOL 150MG TAB safe during pregnancy or breastfeeding?

• Pregnancy: URSOCOL 150MG TAB (ursodeoxycholic acid) is classified as Pregnancy Category B. Animal reproduction studies have not shown harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Therefore, it should only be used during pregnancy if clearly needed and prescribed by a doctor after carefully weighing the potential risks and benefits. It has been used in the last trimester for cholestasis of pregnancy without reported side effects.
• Breastfeeding: Ursodeoxycholic acid is present in human milk at low levels. The amounts ingested by a breastfed infant are generally small and are not expected to cause adverse effects. Many sources suggest that no special precautions are required during breastfeeding for full-term infants.

Can URSOCOL 150MG TAB be taken with other medications?

URSOCOL 150MG TAB can interact with several other medications.

• Reduced effectiveness of Ursocol: The therapeutic efficacy of URSOCOL may be decreased if taken with hormonal birth control pills (containing oestrogenic hormones), certain cholesterol-lowering medicines (like cholestyramine, colestipol, fenofibrate, fenofibric acid), some antacids (especially those containing aluminum hydroxide), and mifepristone. If taking antacids, a gap of at least two hours between doses of Ursocol and the antacid is recommended.
• Altered effects of other drugs: URSOCOL 150MG TAB may increase the effect of immunosuppressants (e.g., cyclosporine). It might also decrease the absorption or excretion rate of certain antibiotics (like ciprofloxacin and dapsone) and antihypertensive agents (such as nitrendipine, felodipine, nifedipine). Always inform your doctor about all medications, supplements, and herbal remedies you are currently taking.

What precautions should be taken while using URSOCOL 150MG TAB?

It is important to inform your doctor about any pre-existing medical conditions, especially if you have stomach or intestinal ulcers or bleeding, inflammatory bowel disease, chronic liver disease, or certain gallbladder disorders other than cholesterol gallstones (e.g., calcified gallstones or a non-functioning gallbladder). Regular monitoring of liver function and bilirubin levels by your doctor is crucial during treatment. Alcohol consumption should be avoided as it can interfere with the medicine's effectiveness and potentially harm the liver. Do not discontinue the medication without consulting your doctor, even if symptoms improve.

What happens if a dose of URSOCOL 150MG TAB is missed?

If you miss a dose of URSOCOL 150MG TAB, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.

How should URSOCOL 150MG TAB be stored?

URSOCOL 150MG TAB should be stored in a cool, dry place, protected from direct sunlight, moisture, and heat. It is typically stored at room temperature, generally below 25°C or 30°C. Keep this medicine out of the sight and reach of children and pets. Discard any unused or expired medicine properly.