URSOCOL 300 MG TABLET

Name

• Brand Name: Ursocol 300 mg Tablet
• Common Name: Ursodeoxycholic Acid (UDCA)

Composition

Each URSOCOL 300 MG TABLET contains 300 mg of Ursodeoxycholic Acid (UDCA) as its active ingredient.

Uses

Ursocol 300 MG Tablet is a hepatoprotective medication primarily used for:

• Dissolution of Cholesterol-Rich Gallstones: It works by reducing the cholesterol content in bile, helping to break down and dissolve certain types of gallstones and prevent their formation.
• Primary Biliary Cholangitis (PBC): This is an autoimmune disease affecting the liver's bile ducts, where the medicine helps by decreasing toxic levels of bile acid and improving liver function.
• Liver Conditions Associated with Cystic Fibrosis: It is used to manage hepatobiliary disorders in children aged 6 to 18 years with cystic fibrosis.
• Other Hepatic Disorders: It is also used for the treatment of cirrhosis and other hepatic diseases.

Dosage and Administration

• Always use URSOCOL 300 MG TABLET exactly as prescribed by your doctor.
• The dosage and duration of treatment depend on the condition being treated, the patient's age, body weight, and severity of the disease.
• Tablets should be swallowed whole with water or milk, typically after a meal.
• For gallstone dissolution, a common dosage is 8 to 10 mg/kg/day, often administered in two to three divided doses, with the last dose recommended at bedtime.
• Continue to take the medicine for the stipulated duration, even if symptoms improve, as it may take several months for gallstones to dissolve completely.

Side Effects

Common side effects may include:

• Diarrhea or loose, watery, or paste-like stools
• Abdominal pain or discomfort
• Nausea and vomiting
• Hair loss
• Itching and rash
• Fatigue
• Headache

If any side effects persist or worsen, consult your doctor.

Precautions

• Pregnancy and Breastfeeding: Consult your doctor before using if you are pregnant or breastfeeding, as limited information is available.
• Alcohol: Avoid alcohol consumption as it may cause excessive drowsiness and worsen liver problems.
• Drug Interactions:
  • Avoid taking antacids within 2 hours of Ursocol 300 Tablet, as they can decrease its effectiveness.
  • Cholestyramine and colestipol may reduce absorption and should be taken at least 2 hours apart.
  • Oral contraceptives, estrogenic hormones, and certain cholesterol-lowering agents may counteract its effects.
  • Use with caution with cyclosporine, as it may increase the risk of liver damage.
• Medical Conditions: Not recommended for patients with allergies to bile acids, calcified gallstones, inflammation of the gallbladder or bile ducts, blockage of bile ducts, frequent upper abdominal pain, or improper gallbladder function. Use with caution in patients with liver diseases.
• Monitoring: Regular monitoring of liver function and bilirubin levels may be required.

Storage

Store URSOCOL 300 MG TABLET in a cool, dry place away from direct sunlight, moisture, and heat. Keep out of the reach of children and pets. Store at room temperature, typically between 10ºC to 25ºC or below 30ºC.

URSOCOL 300 MG TABLET contains Ursodeoxycholic Acid, a naturally occurring bile acid. It is primarily used to treat certain liver and gallbladder conditions.

What is URSOCOL 300 MG TABLET used for?

URSOCOL 300 MG TABLET is used to dissolve certain types of gallstones that are rich in cholesterol and not visible on X-ray, in patients who do not wish to undergo surgery or are not eligible for it. It is also prescribed for the treatment of primary biliary cirrhosis (PBC), a chronic liver disease, and for managing liver dysfunction associated with cystic fibrosis in children aged 6 to 18 years. Additionally, it can help prevent gallstone formation in obese patients undergoing rapid weight loss.

How does URSOCOL 300 MG TABLET work?

Ursodeoxycholic acid, the active ingredient, works by reducing the amount of cholesterol produced and secreted by the liver, and by inhibiting the absorption of cholesterol in the intestines. This action decreases the cholesterol content in bile, helping to dissolve existing cholesterol gallstones and prevent new ones from forming. It also protects liver cells from damage caused by toxic bile acids and improves bile flow.

What is the usual dosage for URSOCOL 300 MG TABLET?

The dosage of URSOCOL 300 MG TABLET varies depending on the condition being treated and the patient's body weight. For dissolving gallstones, it is typically taken at a dose of 8-12 mg/kg/day, usually once daily at bedtime or in two divided doses. For primary biliary cirrhosis (PBC), the usual dosage ranges from 12-16 mg/kg/day, taken in 2-4 divided doses, especially during the initial three months of treatment. It is recommended to take the tablet with or after food. Your doctor will determine the exact dose and duration of treatment.

What are the possible side effects of URSOCOL 300 MG TABLET?

Common side effects include diarrhoea, abdominal discomfort or pain, nausea, headache, muscle or joint pain, and indigestion. Less common side effects can include dizziness, back pain, or hair loss. In rare instances, severe allergic reactions (e.g., swollen face/eyes/lips/tongue, difficulty breathing, widespread itchy skin rashes) or a worsening of liver cirrhosis in advanced primary biliary cirrhosis have been reported. If you experience persistent or bothersome side effects, especially diarrhoea, consult your healthcare professional.

Is URSOCOL 300 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: URSOCOL 300 MG TABLET should only be used during pregnancy if clearly needed and specifically prescribed by your doctor. While animal studies have shown no evidence of harm to the fetus, there are limited adequate and well-controlled studies in pregnant women.

Breastfeeding: Ursodeoxycholic acid is naturally present in human milk. After taking the medication, the levels of ursodeoxycholic acid in breast milk are low and are generally not expected to cause adverse effects in breastfed infants. Therefore, it is usually considered safe during breastfeeding. However, some manufacturers advise caution or against its use during lactation; always consult your doctor or pharmacist.

Can URSOCOL 300 MG TABLET be taken with other medications?

Yes, but certain medications can interact with URSOCOL 300 MG TABLET.

• Reduced effectiveness of Ursocol: Antacids containing aluminum hydroxide and bile acid sequestering agents (like cholestyramine, colestipol, colesevelam) can reduce the absorption and effectiveness of Ursodeoxycholic acid. These should be taken at least two hours apart. Medicines that raise bile cholesterol, such as estrogen-containing oral contraceptives or certain cholesterol-lowering agents (e.g., clofibrate, fenofibrate), may also decrease its effectiveness.
• Increased or decreased levels of other drugs: Ursodeoxycholic acid may affect the absorption or levels of other drugs, such as cyclosporine (requiring monitoring of blood levels), ciprofloxacin, dapsone, nitrendipine, and rosuvastatin.
• Increased adverse effects: The risk or severity of adverse effects can be increased when Ursodeoxycholic acid is combined with clopidogrel or obeticholic acid.

Always inform your doctor or pharmacist about all other medications, supplements, and herbal remedies you are taking.

What precautions should be taken while taking URSOCOL 300 MG TABLET?

Inform your doctor if you have any allergies to the medicine or its ingredients. Exercise caution if you have certain conditions such as calcified gallstones, acute inflammation of the gallbladder or bile ducts, biliary tract obstruction, frequent biliary colic, a non-functioning gallbladder, inflammatory bowel disease, or an active gastric or duodenal ulcer. Your doctor will regularly monitor your liver function tests (e.g., gamma-GT, alkaline phosphatase, AST, ALT, bilirubin), especially during the initial months of treatment. It's advisable to avoid high-calorie or high-cholesterol foods. Women taking this medication for gallstone dissolution should discuss contraception options with their doctor, as estrogen-containing birth control pills may promote gallstone formation.

What happens if a dose of URSOCOL 300 MG TABLET is missed?

If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten one.

How should URSOCOL 300 MG TABLET be stored?

Store URSOCOL 300 MG TABLET in a cool and dry place, away from direct sunlight. Keep the container tightly closed and out of the reach of children.