ursocol sr 450 tablet - Ursodeoxycholic Acid (450mg) medicine

Golbi SR 450 Tablet: Complete Medicine Guide

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🏭 Sun Pharmaceutical Industries Ltd 📦 Varies by brand 💊 Allopathy 📅 Updated: Sep 25, 2026
⚠️ Hepatotoxicity Risk 🤰 Pregnancy Category This medicine is considered safe for use in pregnancy when prescribed for intrahepatic cholestasis of pregnancy. It is classified as FDA Pregnancy Category B. However, it should be used only when clearly needed and under medical supervision. 📋 Prescription Required 💊 Generic Available
Medically Reviewed
11 min read
Evidence: Well-established for gallstone dissolution and primary biliary cholangitis.
Reviewed by
SaathiMed Expert Panel | Sep 25, 2026

When to Call Your Doctor IMMEDIATELY

  • Yellowing of skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe abdominal pain, especially in the upper right quadrant
  • Persistent nausea and vomiting
  • Signs of allergic reaction such as rash, itching, swelling of face or throat, difficulty breathing
  • Unusual tiredness or weakness
  • Increased frequency of bowel movements or severe diarrhea

If experiencing severe symptoms, call emergency services immediately.

What is ursocol sr 450 tablet used for?

This medicine contains Ursodeoxycholic Acid 450 mg, used to dissolve cholesterol gallstones and treat primary biliary cholangitis. It works by reducing cholesterol in bile and protecting liver cells. Take it exactly as prescribed, usually once daily, and do not stop without medical advice.

  • Generic Name: Ursodeoxycholic Acid (450mg)
  • Manufacturer: Sun Pharmaceutical Industries Ltd
  • Form: Allopathy
  • Pregnancy Category: Consult doctor
  • Prescription Required: Yes

🇮🇳 ursocol sr 450 tablet के बारे में (Hindi Summary)

उपयोग: यह दवा अर्सोडीऑक्सीकोलिक एसिड 450 मिलीग्राम युक्त एक सस्टेन्ड-रिलीज़ टैबलेट है, जिसका उपयोग मुख्य रूप से पित्ताशय की पथरी को घोलने, प्राइमरी बिलियरी कोलैंगाइटिस (एक दीर्घकालिक यकृत रोग) के इलाज और गर्भावस्था या सिस्टिक फाइब्रोसिस से जुड़े यकृत विकारों में किया जाता है। यह दवा यकृत में कोलेस्ट्रॉल के उत्पादन को कम करती है और पित्त के प्रवाह को बेहतर बनाती है, जिससे कोलेस्ट्रॉल वाली पथरी धीरे-धीरे घुल जाती है। यह पित्त रोग के कारण होने वाली खुजली को भी कम करती है।

साइड इफेक्ट्स: आमतौर पर यह दवा अच्छी तरह सहन की जाती है, लेकिन कुछ लोगों को मतली, उल्टी, दस्त, कब्ज, या धातु जैसा स्वाद महसूस हो सकता है। ये दुष्प्रभाव आमतौर पर हल्के और अस्थायी होते हैं। दुर्लभ मामलों में यकृत रोग बिगड़ सकता है, जिसके लक्षण हैं आंखों या त्वचा का पीला पड़ना, गहरे रंग का मूत्र, या लगातार थकान। यदि आपको कोई गंभीर या असामान्य लक्षण दिखे, तो तुरंत डॉक्टर से संपर्क करें।

सुरक्षा सलाह: इस दवा को अपने डॉक्टर के निर्देशानुसार ही लें। खुराक को बदलें या दवा बंद करने से पहले डॉक्टर से सलाह लें। टैबलेट को पानी के साथ पूरा निगलें, चबाएं या तोड़ें नहीं। इसे भोजन के साथ या बिना भोजन के ले सकते हैं, लेकिन भोजन के साथ लेने से पेट की परेशानी कम हो सकती है। यदि आप एक खुराक भूल जाते हैं, तो याद आते ही ले लें, लेकिन यदि अगली खुराक का समय नजदीक है, तो भूली हुई खुराक छोड़ दें और सामान्य अनुसूची जारी रखें। दोहरी खुराक न लें। अपने सभी चिकित्सा परीक्षण और प्रयोगशाला जांच समय पर कराएं, क्योंकि डॉक्टर को आपके यकृत की कार्यप्रणाली और पथरी की स्थिति की निगरानी करनी होती है। यदि आप गर्भवती हैं, गर्भवती होने की योजना बना रही हैं, या स्तनपान करा रही हैं, तो अपने डॉक्टर को बताएं। इस दवा के साथ शराब का सेवन न करें, क्योंकि इससे यकृत की समस्या का खतरा बढ़ सकता है। इस दवा को कमरे के तापमान पर, नमी और सीधी धूप से दूर रखें। बच्चों की पहुंच से दूर रखें।

💡 Did You Know? Over 80% of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharmaceutical companies.

💊 ursocol sr 450 tablet Uses & Benefits

[{"condition":"Cholesterol gallstones","description":"Used to dissolve small, non-calcified cholesterol gallstones in patients who cannot undergo surgery or who have a high surgical risk.","evidence":"Well-established"},{"condition":"Primary biliary cholangitis","description":"First-line therapy to slow disease progression and improve liver biochemistry in adults with primary biliary cholangitis.","evidence":"Well-established"},{"condition":"Intrahepatic cholestasis of pregnancy","description":"Used to relieve itching and improve liver function in pregnant women with this condition.","evidence":"Moderate"},{"condition":"Cystic fibrosis-related liver disease","description":"May be used to improve bile flow and liver function in patients with cystic fibrosis.","evidence":"Limited"},{"condition":"Cholestatic liver disease","description":"Helps reduce cholestasis and associated symptoms in various chronic liver diseases.","evidence":"Moderate"}]

Off-label uses: [{"condition":"Non-alcoholic steatohepatitis","description":"Sometimes prescribed off-label to improve liver enzymes, but evidence of benefit is limited.","evidence":"Limited"},{"condition":"Biliary dyskinesia","description":"Occasionally used to relieve symptoms of biliary pain, though evidence is not robust.","evidence":"Limited"}]

Primary treatment for: Cholesterol gallstones

Also treats: Primary biliary cholangitis, Intrahepatic cholestasis of pregnancy, Cystic fibrosis-related liver disease, Cholestatic liver disease

📋 Drug Information

Generic Name(s)Ursodeoxycholic Acid (450mg)
Brand Nameursocol sr 450 tablet
ManufacturerSun Pharmaceutical Industries Ltd
Packaging / FormVaries by brand (Allopathy)
Therapeutic ClassGASTRO INTESTINAL
Action ClassHepatoprotectives
Route of AdministrationOral
StorageStore at room temperature between 15°C and 30°C (59°F to 86°F). Protect from moisture and direct sunlight. Keep in the original container.
Shelf Life24 months from the date of manufacture.
WHO GuidelineNot established from the available information.
ICMR GuidelineNot established from the available information.

👨‍⚕️ Doctor's Practical Tips

Evidence-based practical advice from experienced clinicians

1
Take this medicine at the same time each day to maintain consistent levels in your body.
2
Swallow the tablet whole with water; do not crush or chew the sustained-release formulation.
3
If you are also taking antacids or bile acid sequestrants, separate them by at least 2 hours from this medicine.
4
Regular monitoring of liver function tests is essential while on this medicine, especially for the first few months.
5
For gallstone dissolution, an ultrasound every 6 months is recommended to assess treatment response.
6
Avoid alcohol consumption as it can increase the risk of liver damage.
7
Inform your doctor if you experience persistent diarrhea or any signs of liver problems like yellowing of eyes.

🔍 Is This Medicine Right for Your Symptom?

Educational reference. Always consult a doctor for diagnosis.

✅
Gallstone pain (right upper abdominal pain)
This medicine is commonly prescribed for cholesterol gallstones.
Likely Use
✅
Itching due to liver disease
This medicine helps relieve cholestatic itching.
Likely Use
❌
Fever
This medicine is not a fever reducer.
Not Primary
❌
Headache
This medicine is not used for headaches.
Not Primary

🔬 How This Medicine Works (Pharmacology)

Pharmacokinetics

AbsorptionThis medicine is absorbed from the small intestine after oral administration. The absorption rate is variable and depends on the formulation and presence of food.
DistributionIt is distributed primarily to the liver and bile, with some distribution to the systemic circulation. It is highly protein-bound in plasma.
Protein BindingApproximately 96-99% bound to plasma proteins, mainly albumin.
MetabolismThis medicine is metabolized in the liver by conjugation with glycine or taurine to form glyco- and tauro-ursodeoxycholic acid. It also undergoes bacterial metabolism in the colon.
Half-LifeThe elimination half-life is approximately 3.5 to 5.8 days for the parent drug and its conjugates.
ExcretionIt is excreted primarily in the feces via bile, with a small amount excreted in urine.
BioavailabilityThe bioavailability is approximately 30-60% for the immediate-release formulation, but it may vary with the sustained-release formulation.
Onset of ActionThe onset of action for gallstone dissolution is gradual, typically taking weeks to months. For relief of cholestatic itching, improvement may be seen within a few weeks.
Peak Plasma TimePeak plasma concentrations are reached approximately 1-3 hours after oral administration of the immediate-release form. For the sustained-release form, the peak may be delayed.
Duration of ActionThe effects on bile composition last for several hours after each dose. For gallstone dissolution, continuous therapy for months is required.

How It Works

This medicine works by replacing hydrophobic, detergent-like bile acids in the bile acid pool with the more hydrophilic ursodeoxycholic acid. This reduces cholesterol absorption from the intestine and decreases cholesterol secretion into bile, which helps dissolve cholesterol gallstones. It also stabilizes liver cell membranes, protects against bile acid-induced injury, and stimulates bile flow, which helps relieve cholestasis.

Mechanism Steps

1
Replacement of toxic bile acids: This medicine replaces hydrophobic bile acids in the bile acid pool, reducing their toxic effects on liver cells.
2
Reduction of cholesterol secretion: It decreases cholesterol secretion into bile and reduces intestinal cholesterol absorption, lowering bile cholesterol saturation.
3
Gallstone dissolution: The reduced cholesterol saturation allows cholesterol gallstones to gradually dissolve over months.
4
Choleresis and cytoprotection: It stimulates bile flow and stabilizes liver cell membranes, protecting against cholestatic injury.

💡 How to Take ursocol sr 450 tablet

Strength: Sustained-release tablet containing 450 mg of Ursodeoxycholic Acid.

1Swallow the tablet whole with a glass of water.
2Do not crush, chew, or break the tablet.
3Take it at the same time each day to maintain consistent levels.
4You may take it with or without food, but taking it with meals may reduce stomach upset.
5If you are also taking antacids or bile acid sequestrants, take this medicine at least 2 hours before or after them.

Dosage Information

Adult DosageThe usual adult dose for gallstone dissolution is 8-10 mg/kg/day divided into 2-3 doses, but for this 450 mg sustained-release tablet, the typical dose is one tablet once daily or as directed by your doctor. For primary biliary cholangitis, the dose is 13-15 mg/kg/day divided into 2-4 doses. The exact dose and duration must be individualized by a qualified clinician based on the indication, age, weight, and liver function. Do not adjust the dose without medical advice.
Pediatric DosagePediatric dosing is not established from available information. Consult a pediatrician.
Elderly DosageNo specific dose adjustment is required for elderly patients, but caution is advised due to potential age-related decline in liver and kidney function. Dose should be individualized by a clinician.
Renal ImpairmentNo dose adjustment is required for renal impairment. However, use with caution in severe renal disease.
Hepatic ImpairmentIn patients with severe hepatic impairment, this medicine should be used with caution. Dose adjustment may be necessary based on liver function tests. Consult a hepatologist.
Maximum Daily DoseThe maximum recommended daily dose is 15 mg/kg/day, but for this 450 mg tablet, the maximum is usually one tablet per day unless otherwise prescribed. Do not exceed the dose prescribed by your doctor.

Dosage Timeline

🌅 Morning ❌ ☀️ Afternoon ❌ 🌆 Evening ❌ 🌙 Night ❌

🍽️ Food Timing Guide

With meals
Take with food
Reduces stomach upset and improves absorption.
High-fiber foods
Separate by 2 hours
May reduce absorption of this medicine.
Aluminum-containing antacids
Separate by 2 hours
May bind to this medicine and reduce its effectiveness.

⏰ What to Do If You Miss a Dose

📌 Less than half the dosing interval has passed
→ Take the missed dose as soon as you remember.
💡 Continue with the regular schedule.
📌 More than half the dosing interval has passed
→ Skip the missed dose.
💡 Do not double dose to catch up.

⚠️ Side Effects of ursocol sr 450 tablet

✅ Common Side Effects

Nausea (Common (1-10%))
Take with food to reduce nausea. If it persists, consult your doctor.
Diarrhea (Common (1-10%))
Stay hydrated. If diarrhea is severe or persistent, contact your doctor.
Constipation (Common (1-10%))
Increase fiber and fluid intake. Consult your doctor if it continues.
Vomiting (Common (1-10%))
Take with food and avoid large meals. Seek medical advice if vomiting is severe.
Metallic taste (Uncommon (0.1-1%))
Usually temporary. Chewing sugar-free gum may help.

🚨 Serious Side Effects

Worsening of liver disease (Rare (<0.1%))
Seek immediate medical attention if you notice yellowing of skin or eyes, dark urine, or severe fatigue.
Calcification of gallstones (Rare (<0.1%))
Report to your doctor if you experience increased abdominal pain. Your doctor may monitor with imaging.
Severe allergic reaction (Very rare (<0.01%))
Seek emergency care if you experience rash, swelling of face or throat, or difficulty breathing.

⚠️ Rare Side Effects

Pancreatitis
Seek immediate medical attention if you have severe upper abdominal pain radiating to the back.
Leukopenia
Report any unusual infections or fever to your doctor.

Consult your doctor if you experience any unusual symptoms.

🔬 Drug Interactions

Drug Severity Effect
Aluminum-based antacids Major
Cholestyramine Major
Colestipol Major
Colesevelam Major
Oral contraceptives Moderate
Clofibrate Moderate
Cyclosporine Moderate
Ciprofloxacin Moderate
Nitrendipine Moderate
Dapsone Moderate

🚨 Major Interactions

  • Aluminum-based antacids
  • Cholestyramine, colestipol, colesevelam
  • Oral contraceptives containing estrogen
  • Clofibrate
  • Cyclosporine

⚡ Moderate Interactions

  • Ciprofloxacin
  • Nitrendipine
  • Dapsone

🍷 Alcohol Interaction

Alcohol may increase the risk of liver damage and can worsen the underlying liver condition. It is advisable to avoid alcohol while taking this medicine.

🔎 Check Your Other Medicines

Educational tool. Always confirm with your doctor or pharmacist.

🛡️ Safety & Warnings

🚫 Contraindications

["Complete biliary obstruction","Acute cholecystitis or cholangitis","Calcified cholesterol gallstones","Gallstones larger than 15 mm in diameter","Severe hepatic impairment or hepatic encephalopathy","Hypersensitivity to ursodeoxycholic acid or any component of the formulation","Non-functioning gallbladder"]

⚠️ Warnings & Precautions

["Use with caution in patients with severe liver disease; monitor liver function regularly.","Patients with gallstones should be monitored with ultrasound to detect calcification or worsening.","This medicine may not be effective if gallstones are radiopaque or larger than 15 mm.","Avoid concurrent use with bile acid sequestrants; separate administration times.","Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.","Do not use this medicine for gallstone dissolution if you have a non-functioning gallbladder.","In patients with primary biliary cholangitis, monitor for response and consider alternative therapy if no improvement after 1 year."]

🤱 Lactation Safety

It is not known whether this medicine is excreted in human breast milk. It should be used with caution during breastfeeding, and only if the potential benefit justifies the potential risk to the infant.

💊 Overdose Management

Overdose with this medicine is unlikely to cause serious effects. In case of suspected overdose, seek immediate medical attention. Treatment is supportive and symptomatic. Diarrhea may occur and should be managed with hydration.

⏰ Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.

Additional Safety Advice

General Safety

Take this medicine exactly as prescribed by your doctor. Do not change the dose or stop taking it without medical advice. Swallow the tablet whole with a glass of water; do not crush or chew it. You may take it with or without food, but taking it with meals may reduce stomach upset. If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose. Keep all your medical appointments and laboratory tests, as your doctor will need to monitor your liver function and gallstone status. Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Avoid alcohol while taking this medicine, as it can increase the risk of liver problems. Store this medicine at room temperature, away from moisture and direct sunlight. Keep it out of reach of children.

👴 Special Considerations for Elderly

💡 For Patients Above 65

Elderly patients may have reduced liver function and should be monitored more closely. No specific dose adjustment is required, but individualization is advised.

🤰 Pregnancy Planning (TTC)

If you are planning to become pregnant, consult your doctor before starting or continuing this medicine. It is considered safe for use in pregnancy when prescribed for intrahepatic cholestasis of pregnancy, but use only under medical supervision.

🏥 Post-Surgery Considerations

If you have undergone gallbladder removal surgery, this medicine is generally not needed for gallstone dissolution. However, it may be continued for other liver conditions as prescribed by your doctor.

🦷 Dental Procedures

No specific precautions are required for dental procedures. Inform your dentist about all medicines you are taking.

💚 Lifestyle Tips for Better Results

🏃
Maintain a healthy weight to reduce the risk of gallstones.
🥗
Eat a low-fat, high-fiber diet to support liver health.
😴
Stay physically active with regular exercise like walking or swimming.
💧
Avoid alcohol and smoking to protect your liver.
🧘
Drink plenty of water throughout the day.
🌞
Get adequate sleep to help your body recover.

🏋️ Exercise Considerations

No specific exercise restrictions are required while taking this medicine. However, if you have gallstone pain or liver disease, consult your doctor before starting any strenuous exercise program.

🥗 Diet Recommendations

Include plenty of fruits and vegetables.
Choose whole grains over refined grains.
Limit saturated and trans fats.
Reduce sugar and processed foods.
Stay well hydrated.

💼 Impact on Daily Work & Life

This medicine is unlikely to affect your ability to drive or operate machinery. However, if you experience dizziness or fatigue, avoid these activities until you know how the medicine affects you.

🛑 When to Stop This Medicine

Do not stop taking this medicine without consulting your doctor. For gallstone dissolution, treatment is usually continued for several months after the stones have dissolved to prevent recurrence. For primary biliary cholangitis, it is often a lifelong therapy. Your doctor will determine when it is safe to stop based on your condition and test results.

📅 Long-Term Use Effects

Long-term use of this medicine is generally safe and well-tolerated. It may be continued for months to years for gallstone dissolution or indefinitely for primary biliary cholangitis. Regular monitoring of liver function tests and gallstone status is recommended. In rare cases, gallstones may calcify and become resistant to dissolution. Long-term use has not been associated with significant toxicity, but periodic evaluation by your doctor is necessary.

🌿 Non-Medicine Approaches

These can complement medicine but do not replace prescribed treatment.

Surgery (cholecystectomy)

Surgical removal of the gallbladder is the definitive treatment for symptomatic gallstones.

Evidence: Well-established
Extracorporeal shock wave lithotripsy

Non-invasive procedure to break up gallstones using shock waves, suitable for selected patients.

Evidence: Moderate
Lifestyle modifications

Diet and weight management can help prevent gallstone formation.

Evidence: Well-established

💉 Vaccination Considerations

💉 If You're Getting Vaccinated

No specific vaccine interactions are known. However, patients with chronic liver disease should receive hepatitis A and B vaccines as recommended by their doctor.

📦 Storage Guide

✅ DO

Store at room temperature (15-30°C)

❌ DON'T

Do not refrigerate unless specified

✅ DO

Keep in original container

❌ DON'T

Do not transfer to unmarked containers

✅ DO

Keep away from direct sunlight

❌ DON'T

Do not store in bathroom cabinet

✈️ Traveling with This Medicine

When traveling, carry your medicine in its original packaging along with a copy of your prescription. Keep it in your carry-on luggage to avoid loss. Store at room temperature and protect from extreme heat or moisture. If crossing time zones, continue taking your dose at the same local time as much as possible; consult your doctor if you need to adjust the timing. Check customs regulations for carrying prescription medicines to your destination.

💰 Cost Analysis & Savings

👥 Real Patient Stories

Educational, anonymized scenarios. Individual results may vary.

👤 A 52-year-old woman with symptomatic gallstones who was not a candidate for surgery.
She was prescribed this medicine 450 mg once daily. After 6 months of continuous therapy, an ultrasound showed that her gallstones had reduced in size. She experienced mild nausea initially, which subsided after taking the tablet with breakfast. She emphasized the importance of not missing doses.
💡 Lesson: Consistent daily intake and taking the medicine with food can improve tolerability and effectiveness.
👤 A 38-year-old pregnant woman with intrahepatic cholestasis of pregnancy experiencing severe itching.
She started this medicine at 450 mg daily in her third trimester. Within two weeks, her itching significantly decreased, and her liver enzymes improved. She delivered a healthy baby and continued the medicine briefly postpartum under medical supervision.
💡 Lesson: This medicine can safely relieve cholestatic itching in pregnancy when prescribed and monitored by a doctor.

💬 Questions Patients Often Ask

Q: How long does it take to work?

A: For gallstone dissolution, it may take several months to years depending on the size and number of stones. For relief of cholestatic itching, improvement may be seen within a few weeks.

Q: Can I take this medicine with food?

A: Yes, you can take it with or without food, but taking it with meals may reduce stomach upset.

Q: What should I do if I miss a dose?

A: Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Q: Is this medicine safe during pregnancy?

A: It is considered safe for use in pregnancy when prescribed for intrahepatic cholestasis of pregnancy. However, it should be used only under medical supervision.

Q: Can I drink alcohol while taking this medicine?

A: It is advisable to avoid alcohol as it may increase the risk of liver damage.

🤔 Common Patient Concerns

💭 These are the concerns patients most commonly raise

  • Can I take this medicine long-term?
  • Will it affect my kidney function?
  • Can I drive after taking this medicine?
  • Does it interact with my blood pressure medicine?
  • What if I miss a dose?
  • Can I drink alcohol while taking this?
  • Is it safe during pregnancy?
  • How long does it take to dissolve gallstones?

🔄 Substitutes for ursocol sr 450 tablet

View All

Alternative brands with exact same active ingredient:

Medical Note: Always consult your doctor before switching medications.

🛑 Myths vs. Facts

  • Myth: This medicine can dissolve all types of gallstones.
    Fact: It is only effective for cholesterol gallstones that are small and non-calcified. It does not work for pigment stones or calcified stones.
  • Myth: You can stop taking this medicine once you feel better.
    Fact: Gallstone dissolution requires months of continuous therapy. Stopping early may cause stones to recur or not dissolve completely.
  • Myth: This medicine is a painkiller.
    Fact: It is not a painkiller. It works by dissolving gallstones and improving liver function, which may indirectly reduce pain.

🔄 Alternative Options

Generic Alternatives

  • Ursodeoxycholic Acid 450 mg sustained-release tablet

Brand Alternatives

  • Golbi SR 450 Tablet
  • Udiliv 450 Tablet
  • Ursocol 450 Tablet
  • Sorbidiol 450 Tablet

📊 Comparison with Similar Medicines

[{"medicine":"Ursodeoxycholic Acid","class":"Bile acid","primary_use":"Gallstone dissolution, primary biliary cholangitis","route":"Oral"},{"medicine":"Chenodeoxycholic acid","class":"Bile acid","primary_use":"Gallstone dissolution","route":"Oral"},{"medicine":"Obeticholic acid","class":"Farnesoid X receptor agonist","primary_use":"Primary biliary cholangitis","route":"Oral"}]

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