Ursocol 450 Sr Tablet (15 Tab)

URSOCOL 450 SR TABLET (15 TAB) by SIGNOVA PHARMA (P) LTD.

Name

• Brand Name: URSOCOL 450 SR TABLET
• Common Name: Ursodeoxycholic Acid (UDCA) 450 mg

Composition

Each sustained-release (SR) tablet contains 450 mg of Ursodeoxycholic Acid (UDCA).

Uses

URSOCOL 450 SR TABLET is a hepatoprotective medication primarily used for:

• Dissolution of cholesterol-rich gallstones and prevention of their formation.
• Treatment of primary biliary cirrhosis (PBC), also known as primary biliary cholangitis, a chronic liver disease.
• Management of biliary and liver diseases associated with cystic fibrosis in children aged 6 to 18 years.
• Treatment for cholestasis, including pregnancy-related cholestasis.

Dosage and Administration

• URSOCOL 450 SR TABLET should be swallowed whole after a meal, with a glass of milk or water.
• The dosage and duration of treatment are determined by the physician based on the patient's condition, body weight, age, and severity of the disease.
• It is crucial to take the medicine regularly for the prescribed duration, which may extend for several months or longer, even if symptoms improve or disappear.
• For dissolving gallstones, it is often recommended to be taken once daily at night.
• Typical dosages range from 8 to 10 mg/kg/day for gallstone dissolution and 12-15 mg/kg/day for primary biliary cholangitis, often divided into two or three portions daily.

Side Effects

Common side effects may include:

• Abdominal pain or discomfort.
• Diarrhea (if persistent or bloody, stop medication and consult doctor).
• Nausea or vomiting.
• Indigestion.
• Headache.
• Rash or itching.
• Hair loss.
• Fatigue or weakness.
• Dizziness.
• Other less common side effects reported include back pain, bloody and cloudy urine, black or tarry stools, burning or painful urination, fever and cough, swelling of eyelids, face, lips, tongue, and joint pain. Most side effects are usually mild and resolve over time. Consult a doctor if any side effects persist or worsen.

Precautions

• Allergies: Do not take if allergic to Ursodeoxycholic Acid or any of its components.
• Contraindications: Avoid use in conditions such as inflammation of the gallbladder or bile ducts, blockage in bile ducts, calcified gallstones, non-functioning gallbladder, gallstone pancreatitis, or active peptic ulcer disease.
• Pregnancy: May be unsafe during pregnancy; consult a doctor. It should only be used if clearly necessary.
• Breastfeeding: Use with caution during breastfeeding; consult a doctor.
• Liver Impairment: Use with caution in patients with liver problems; liver function may be monitored.
• Alcohol: Avoid alcohol consumption as it may increase drowsiness and liver damage.
• Drug Interactions:
  • Avoid taking concurrently with antacids containing aluminum hydroxide/smectite, cholestyramine, or colestipol, as these can reduce its effectiveness. If necessary, take at least 2 hours before or after URSOCOL 450 SR TABLET.
  • Oral contraceptives, estrogenic hormones, and cholesterol-lowering agents (e.g., clofibrate) may increase the risk of gallstone formation and should be avoided.
  • May affect the absorption of certain antibiotics (e.g., ciprofloxacin, dapsone) and antihypertensive agents (e.g., nitrendipine).
  • May increase the effect of immunosuppressants like cyclosporine; blood levels of cyclosporine should be monitored.
• Monitoring: Regular monitoring of liver function and bilirubin levels may be advised by your doctor during treatment.

Storage

Store URSOCOL 450 SR TABLET in a cool and dry place, away from direct sunlight, at room temperature (below 30°C). Keep out of sight and reach of children.

URSOCOL 450 SR TABLET is a medication primarily used to dissolve certain types of gallstones and to treat various liver conditions. It contains ursodeoxycholic acid, a naturally occurring bile acid.

What is URSOCOL 450 SR TABLET used for?

URSOCOL 450 SR TABLET is used to dissolve cholesterol-rich gallstones and prevent their formation, especially in overweight individuals undergoing rapid weight loss. It also treats primary biliary cirrhosis (PBC) or primary biliary cholangitis, a liver disease that impairs liver function. Additionally, it is prescribed for liver and biliary diseases associated with cystic fibrosis in children aged 6 to 18 years.

How does URSOCOL 450 SR TABLET work?

The active ingredient, ursodeoxycholic acid, works by decreasing the production and absorption of cholesterol in the liver and intestines, thereby reducing the cholesterol content in bile. This action helps dissolve existing cholesterol gallstones and prevents new ones from forming. It also protects liver cells from damage caused by toxic bile acids and improves overall liver function.

What is the usual dosage for URSOCOL 450 SR TABLET?

The dosage of URSOCOL 450 SR TABLET is determined by your doctor based on your specific condition, body weight, age, and the severity of the illness. For dissolving gallstones, a common dosage is 8-12 mg/kg once daily at bedtime or in two divided doses, continuing for several months up to two years. For primary biliary cholangitis, the dosage is typically 10-16 mg/kg/day, taken in two to three divided doses. It should be swallowed whole after a meal with a glass of milk or water. It's crucial to take the medicine regularly for the prescribed duration, even if symptoms improve, to ensure effectiveness.

What are the possible side effects of URSOCOL 450 SR TABLET?

Common side effects include diarrhea, abdominal pain or discomfort, nausea, vomiting, indigestion, rash, itching, hair loss, headache, and dizziness. Some less common side effects can include back pain, bloody or cloudy urine, black or tarry stools, burning or painful urination, fever, cough, swelling of the eyelids, face, lips, or tongue, and joint pain. If any side effects persist or worsen, you should consult your doctor. Persistent diarrhea may require a dose adjustment or discontinuation of the treatment.

Is URSOCOL 450 SR TABLET safe during pregnancy or breastfeeding?

Pregnancy: URSOCOL 450 SR TABLET is generally not recommended during pregnancy unless absolutely necessary and prescribed by a doctor, who will weigh the potential benefits against the risks. It belongs to pregnancy category B. Breastfeeding: Caution is advised when considering URSOCOL 450 SR TABLET during breastfeeding, as it is not known if the active ingredient passes into breast milk. Your doctor will discuss the risks and benefits before recommending its use.

Can URSOCOL 450 SR TABLET be taken with other medications?

URSOCOL 450 SR TABLET can interact with other medications, so it is important to inform your doctor about all other medicines you are taking.

• Avoid or use with caution:
  • Hormonal birth control pills: These may increase the risk of gallstone production and should be discontinued.
  • Cholesterol-lowering medicines (e.g., cholestyramine, colestipol, clofibrate, atorvastatin): These can reduce the effectiveness of Ursocol.
  • Antacids containing aluminum hydroxide, smectite, or charcoal: These can decrease the absorption and efficacy of Ursocol. If necessary, take them at least 2 hours before or after Ursocol.
  • Certain antibiotics (e.g., ciprofloxacin, dapsone) and antihypertensive agents (e.g., nitrendipine): Their effectiveness may be altered.
  • Immunosuppressants (e.g., ciclosporin): Ursocol may affect cyclosporine absorption, so blood levels should be monitored and doses adjusted if needed.

What precautions should be taken when using URSOCOL 450 SR TABLET?

Inform your doctor if you have any allergies to ursodeoxycholic acid or other ingredients in the tablet. This medicine is not recommended if you have biliary obstruction, inflammation of the gallbladder or bile ducts, blockage of bile ducts, gallstone pancreatitis, or a non-functional gallbladder. Use with caution if you have liver problems, a swollen gallbladder, variceal bleeding, ascites, liver encephalopathy, or stomach/intestinal ulcers. Your doctor may conduct regular liver function tests to monitor your condition. Avoid consuming alcohol while taking this medication, as it may increase drowsiness and liver damage. It's also advisable to avoid a high-cholesterol diet. Do not stop taking the medication abruptly without consulting your doctor, as this may lead to a recurrence of gallstones.

What happens if a dose of URSOCOL 450 SR 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 the missed one.

How should URSOCOL 450 SR TABLET be stored?

URSOCOL 450 SR TABLET should be stored in a cool and dry place, away from direct sunlight. The recommended storage temperature is below 30°C, or at room temperature. Keep this medicine out of the sight and reach of children.