Ursoren
Generic Name
Ursodeoxycholic Acid (UDCA)
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursoren 150 mg tablet | ৳ 15.00 | ৳ 150.00 |
| ursoren 300 mg tablet | ৳ 25.00 | ৳ 150.00 |
Description
Overview of the medicine
Ursoren contains Ursodeoxycholic Acid (UDCA), a naturally occurring bile acid. It is used to dissolve cholesterol gallstones, and to treat primary biliary cholangitis (PBC) and certain liver conditions.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day orally in 2-3 divided doses. For PBC: 13-15 mg/kg/day orally in 2-4 divided doses.
Elderly
No specific dose adjustment generally needed, but monitor renal and hepatic function.
Renal_impairment
No specific dose adjustment recommended.
How to Take
Orally, with food. For gallstone dissolution, administration before bedtime may be beneficial.
Mechanism of Action
UDCA alters the composition of bile, reducing cholesterol saturation and facilitating the dissolution of cholesterol gallstones. It also exhibits hepatoprotective, anti-inflammatory, and immunomodulatory effects in various cholestatic liver diseases.
Pharmacokinetics
Onset
Gallstone dissolution typically takes 6-24 months. PBC symptom improvement varies.
Excretion
Excreted in feces as unconjugated UDCA and its metabolites.
Half life
Approximately 3.5-5.8 days.
Absorption
Rapidly absorbed from the GI tract (approximately 90%).
Metabolism
Undergoes extensive enterohepatic recirculation; conjugated in the liver.
Side Effects
Contraindications
- Known hypersensitivity to UDCA or any component
- Calcified cholesterol stones, radio-opaque gallstones, or functioning gallbladder
- Acute cholecystitis, cholangitis, or biliary obstruction
- Severe liver disease (e.g., decompensated cirrhosis)
Drug Interactions
Estrogens, Oral Contraceptives, Clofibrate
May increase cholesterol saturation of bile, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
May reduce UDCA absorption. Administer at least 1 hour apart.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose is rare. Diarrhea may be a symptom. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. UDCA is excreted into breast milk in very low concentrations; generally considered compatible with breastfeeding, but consult a doctor.
Side Effects
Contraindications
- Known hypersensitivity to UDCA or any component
- Calcified cholesterol stones, radio-opaque gallstones, or functioning gallbladder
- Acute cholecystitis, cholangitis, or biliary obstruction
- Severe liver disease (e.g., decompensated cirrhosis)
Drug Interactions
Estrogens, Oral Contraceptives, Clofibrate
May increase cholesterol saturation of bile, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
May reduce UDCA absorption. Administer at least 1 hour apart.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose is rare. Diarrhea may be a symptom. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. UDCA is excreted into breast milk in very low concentrations; generally considered compatible with breastfeeding, but consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated UDCA's efficacy in gallstone dissolution and PBC. Ongoing research explores its role in other liver diseases.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) at baseline and every 3-6 months
- Serum cholesterol levels for gallstone dissolution
- Ultrasound imaging of gallstones at 6-12 month intervals
Doctor Notes
- Emphasize patient compliance for long-term treatment of gallstones or PBC.
- Monitor liver function tests regularly.
- Advise patients about potential side effects like diarrhea.
Patient Guidelines
- Take with food
- Do not stop treatment abruptly without consulting your doctor
- Report any severe abdominal pain or persistent diarrhea
- For gallstone dissolution, long-term treatment may be required
Missed Dose Advice
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Generally no effect on ability to drive or operate machinery. However, if dizziness or other side effects occur, avoid driving.
Lifestyle Advice
- Maintain a healthy weight
- Follow a balanced diet low in saturated fat and cholesterol
- Engage in regular physical activity
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