Ursocol Sr 600 Mg Tablet ( 10 Tab )

URSOCOL SR 600 MG TABLET

• Name: URSOCOL SR 600 MG TABLET (also known as Ursocol SR 600 Tablet).
  • Brand: URSOCOL SR
  • Manufacturer: SUN PHARMACEUTICAL IND.LTD.
• Composition: Each tablet contains Ursodeoxycholic Acid (UDCA) 600 mg, in a sustained-release (SR) formulation.
• Uses:
  • Dissolving cholesterol gallstones and preventing their formation, especially in overweight individuals undergoing rapid weight loss.
  • Treatment of Primary Biliary Cirrhosis (PBC), an autoimmune liver disease.
  • Management of liver-related conditions in children aged above 6 years, including those with biliary and liver diseases caused by cystic fibrosis.
  • Addressing excess cholesterol in the bile and managing cholestasis (e.g., pregnancy-related).
• Dosage and Administration:
  • URSOCOL SR 600 MG TABLET should be taken orally, swallowed whole with a glass of milk or water after a meal; do not crush, chew, or break the tablet.
  • The specific dosage and duration of treatment are determined by the physician based on the patient's body weight, medical condition, and specific indication.
  • For gallstone dissolution, a typical adult dose is 8-10 mg/kg daily, often as a single dose at bedtime. For PBC, 10-15 mg/kg daily in 2-4 divided doses is common.
  • Continue treatment as prescribed, even if symptoms improve or disappear.
• Side Effects:
  • Common: Diarrhea, nausea, vomiting, abdominal pain or discomfort, headache, hair loss, itching, and rash.
  • Most side effects are temporary; however, consult a doctor if they persist or worsen.
• Precautions:
  • Avoid if allergic to Ursodeoxycholic Acid or other bile acids.
  • Use with caution in patients with liver problems, gallbladder inflammation, calcified gallstones, or a non-visualizing gallbladder.
  • Not recommended for patients with complete bile duct obstruction, severe liver disease, or certain inflammatory bowel diseases.
  • Pregnant or breastfeeding women should consult their doctor before use.
  • Avoid alcohol consumption as it may increase drowsiness and liver damage.
  • Interactions may occur with antacids, bile acid sequestrants (e.g., cholestyramine), certain antibiotics, oral contraceptives, and lipid-lowering agents. Inform your doctor about all current medications.
  • Regular monitoring of liver function and bilirubin levels may be required.
• Storage:
  • Store in a cool, dry place, below 30°C (15-25°C), away from direct sunlight, heat, and moisture.
  • Keep out of sight and reach of children and pets.
  • Do not use after the expiry date.

URSOCOL SR 600 MG TABLET contains Ursodeoxycholic Acid (UDCA) and is commonly prescribed for various liver and gallbladder conditions. Here are some frequently asked questions about this medication:

1. What is URSOCOL SR 600 MG TABLET used for?

URSOCOL SR 600 MG TABLET is primarily used to dissolve gallstones that are composed mainly of cholesterol. It is also used to treat Primary Biliary Cholangitis (PBC), which is an autoimmune disease affecting the bile ducts in the liver. Additionally, it may be used for liver diseases associated with cystic fibrosis in children above 6 years of age, and to prevent gallstones in individuals who are rapidly losing weight.

2. How does URSOCOL SR 600 MG TABLET work?

This medicine contains ursodeoxycholic acid, which is a naturally occurring bile acid. It works by decreasing the amount of cholesterol produced by the liver and secreted into the bile, thereby helping to dissolve cholesterol-based gallstones. It also protects liver cells from damage caused by toxic bile acids and helps improve overall liver function.

3. What is the usual dosage for URSOCOL SR 600 MG TABLET?

The dosage of URSOCOL SR 600 MG TABLET is determined by your doctor based on your specific medical condition and body weight. It should be swallowed whole with a glass of milk or water, preferably after a meal. Do not chew, crush, or break the tablet. For gallstone dissolution, it is often prescribed once daily at night, and treatment can last for several months or longer. It's crucial not to exceed the recommended dose.

4. What are the possible side effects of URSOCOL SR 600 MG TABLET?

Common side effects may include abdominal discomfort or pain, diarrhea, nausea, rash, dizziness, indigestion, weakness, hair loss, and itching. These side effects usually resolve over time. If they persist or worsen, you should consult your doctor.

5. Is URSOCOL SR 600 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: There is limited information on the safety of URSOCOL SR 600 MG TABLET during pregnancy, and animal studies have shown potential harmful effects. Therefore, it is generally advised not to take this medicine if you are pregnant unless specifically prescribed by your doctor, who will weigh the benefits against potential risks. Breastfeeding: The safety of URSOCOL SR 600 MG TABLET during breastfeeding is not well established. It should be used with caution, and breastfeeding mothers should consult their doctor before taking this medicine.

6. Can URSOCOL SR 600 MG TABLET be taken with other medications?

URSOCOL SR 600 MG TABLET can interact with several other medications. It is important to inform your doctor about all medicines you are currently taking.

• Avoid or use with caution with: Antacids (especially aluminum-containing ones), cholesterol-lowering medicines (like cholestyramine, colestipol, colesevelam, clofibrate), hormonal birth control pills or estrogen-containing hormones, antibiotics (such as ciprofloxacin), immunosuppressants (like cyclosporine), and certain antihypertensive agents (like nitrendipine).
• A gap of at least 4 hours should be maintained between taking URSOCOL SR 600 MG TABLET and certain interacting medicines like bile acid sequestrants.

7. What precautions should be taken while using URSOCOL SR 600 MG TABLET?

Inform your doctor if you have known allergies to ursodeoxycholic acid or any of its components. This medicine should be used with caution if you have conditions such as variceal bleeding, ascites, liver encephalopathy, gallbladder inflammation, bile duct obstruction, calcified gallstones, or gastric/duodenal ulcers. Regular liver function tests and ultrasound scans may be required during treatment. Avoid consuming alcohol, as it can increase drowsiness and risk liver damage. Women of childbearing age should use non-hormonal contraceptive methods or low-estrogen oral contraceptive pills.

8. What happens if a dose of URSOCOL SR 600 MG TABLET is missed?

If you miss a dose, 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 make up for a missed one.

9. How should URSOCOL SR 600 MG TABLET be stored?

Store URSOCOL SR 600 MG TABLET in a cool and dry place, away from direct sunlight, heat, and moisture. Keep it in its original packaging and out of sight and reach of children. Do not use the medicine after its expiry date.