Ursocol
Generic Name
Ursodeoxycholic Acid
Manufacturer
Sun Pharmaceutical Industries Ltd.
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursocol 300 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Ursocol 300 mg Tablet contains Ursodeoxycholic acid, a naturally occurring bile acid used to dissolve cholesterol gallstones, treat primary biliary cholangitis (PBC), and manage various cholestatic liver diseases.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually as a single dose at bedtime or in 2 divided doses. For PBC: 13-15 mg/kg/day in 2-4 divided doses, with food.
Elderly
No specific dosage adjustment required, but cautious use due to potential comorbidities and polypharmacy.
Renal_impairment
No dosage adjustment required as it is primarily excreted via bile and not significantly renally cleared.
How to Take
Administer orally, usually with a meal or snack to enhance absorption and reduce gastrointestinal side effects. For gallstone dissolution, a single evening dose is often preferred. For PBC, divided doses are recommended.
Mechanism of Action
Ursodeoxycholic acid reduces cholesterol saturation in bile, leading to the dissolution of cholesterol gallstones. It also replaces toxic bile acids in cholestatic liver diseases, protects liver cells, and has immunomodulatory effects.
Pharmacokinetics
Onset
Gallstone dissolution may take months (6-24 months); symptomatic relief for liver conditions can be earlier.
Excretion
Primarily excreted in feces via bile after hepatic metabolism.
Half life
Approximately 3.5-5.8 days.
Absorption
Well absorbed orally (approx. 90%) after conjugation in the liver; peak plasma concentrations reached in 1-3 hours.
Metabolism
Undergoes extensive enterohepatic recirculation; conjugated with glycine or taurine in the liver, followed by bacterial dehydroxylation in the intestine.
Side Effects
Contraindications
- Acute cholecystitis
- Cholangitis
- Non-cholesterol gallstones (e.g., calcified gallstones, pigment stones)
- Biliary tract obstruction (e.g., common bile duct obstruction)
- Frequent attacks of biliary colic
- Acute gastric or duodenal ulcer
- Known allergy to bile acids or any component of the tablet
Drug Interactions
Cyclosporine, Dapsone, Nitrendipine
UDCA may increase their absorption and plasma levels, requiring dose adjustments.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation in bile, counteracting UDCA's gallstone-dissolving effect.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
May reduce UDCA absorption; administer UDCA at least 2 hours before or after these agents.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Diarrhea may be a symptom of overdose. Symptomatic treatment, including supportive measures and monitoring of liver function, is recommended.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed and the potential benefits outweigh the risks. Ursodeoxycholic acid is excreted into breast milk in very small amounts; caution is advised during breastfeeding.
Side Effects
Contraindications
- Acute cholecystitis
- Cholangitis
- Non-cholesterol gallstones (e.g., calcified gallstones, pigment stones)
- Biliary tract obstruction (e.g., common bile duct obstruction)
- Frequent attacks of biliary colic
- Acute gastric or duodenal ulcer
- Known allergy to bile acids or any component of the tablet
Drug Interactions
Cyclosporine, Dapsone, Nitrendipine
UDCA may increase their absorption and plasma levels, requiring dose adjustments.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation in bile, counteracting UDCA's gallstone-dissolving effect.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
May reduce UDCA absorption; administer UDCA at least 2 hours before or after these agents.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Diarrhea may be a symptom of overdose. Symptomatic treatment, including supportive measures and monitoring of liver function, is recommended.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed and the potential benefits outweigh the risks. Ursodeoxycholic acid is excreted into breast milk in very small amounts; caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, specific to manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
Approved by various health authorities (e.g., FDA)
Patent Status
Off-patent
Clinical Trials
Ursodeoxycholic acid has been extensively studied for gallstone dissolution and PBC. Ongoing research explores its potential in other liver conditions like non-alcoholic steatohepatitis (NASH) and cystic fibrosis-associated liver disease.
Lab Monitoring
- Liver function tests (e.g., AST, ALT, ALP, GGT, bilirubin) at baseline and every 3-6 months, especially during the first year of treatment.
- Ultrasound of the gallbladder periodically (every 6-12 months) for gallstone dissolution to monitor progress.
Doctor Notes
- Emphasize the importance of adherence to the treatment regimen due to the long duration required for gallstone dissolution or PBC management.
- Monitor liver function tests regularly, especially during the initial months of treatment and for patients with advanced liver disease.
- Advise patients about potential drug interactions, particularly with bile acid sequestrants and antacids.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Ursocol without consulting your doctor, even if you feel better.
- Report any new or worsening abdominal pain, persistent diarrhea, or signs of jaundice immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Ursocol is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or other side effects that affect your concentration, avoid these activities.
Lifestyle Advice
- Maintain a healthy diet low in cholesterol and saturated fats.
- Regular exercise and maintaining a healthy weight can support overall liver health.
- Avoid rapid weight loss, which can exacerbate gallstone formation.
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