Ursoren
Generic Name
Ursodeoxycholic Acid
Manufacturer
Square 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 |
Description
Overview of the medicine
Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used to dissolve cholesterol gallstones in patients who cannot undergo surgery and to treat primary biliary cholangitis (PBC). It works by reducing the cholesterol content of bile.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually divided into 2-3 doses, with the last dose at bedtime. For PBC: 13-15 mg/kg/day in 2-4 divided doses with food. For biliary reflux gastritis: 250 mg once daily at bedtime for 10-14 days.
Elderly
No specific dosage adjustment is typically required, but caution should be exercised in patients with significant comorbidities.
Renal_impairment
No dosage adjustment is generally needed as UDCA is primarily excreted in feces.
How to Take
Take orally with food. For gallstone dissolution, the last dose is often taken at bedtime. For PBC, doses are usually divided and taken with meals.
Mechanism of Action
UDCA reduces cholesterol saturation of bile by suppressing hepatic cholesterol synthesis and secretion into bile. It also facilitates the dispersion of cholesterol in bile into liquid crystals and micelles, thus aiding in the dissolution of gallstones. Additionally, it has cytoprotective, anti-apoptotic, and immunomodulatory effects in liver diseases.
Pharmacokinetics
Onset
Effects on bile composition may be seen within a few weeks; gallstone dissolution takes several months to years.
Excretion
Primarily excreted in feces via biliary secretion. A small amount is excreted in urine.
Half life
Approximately 3-5 days (due to enterohepatic recirculation).
Absorption
Well absorbed (approximately 90%) after oral administration. Peak plasma concentration occurs within 1-3 hours.
Metabolism
Undergoes extensive enterohepatic recirculation, with significant metabolism in the liver (conjugation with glycine and taurine) and bacterial degradation in the intestine.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation.
- Acute cholecystitis, cholangitis, or other acute inflammatory conditions of the gallbladder or bile ducts.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
- Biliary tract obstruction.
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin; monitor ciclosporin levels.
Oral Contraceptives, Estrogens, Clofibrate
May increase hepatic cholesterol secretion, thereby counteracting the effect of UDCA on gallstone dissolution.
Cholestyramine, Colestipol, Antacids (aluminum hydroxide-containing)
These agents can bind to UDCA in the intestine and reduce its absorption; take UDCA at least 2 hours before or after these medications.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The only symptom of overdose is typically diarrhea. Management involves symptomatic treatment and replacement of fluids and electrolytes.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed and potential benefits outweigh risks. It is unknown if UDCA is excreted in human milk; use with caution during lactation.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation.
- Acute cholecystitis, cholangitis, or other acute inflammatory conditions of the gallbladder or bile ducts.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
- Biliary tract obstruction.
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin; monitor ciclosporin levels.
Oral Contraceptives, Estrogens, Clofibrate
May increase hepatic cholesterol secretion, thereby counteracting the effect of UDCA on gallstone dissolution.
Cholestyramine, Colestipol, Antacids (aluminum hydroxide-containing)
These agents can bind to UDCA in the intestine and reduce its absorption; take UDCA at least 2 hours before or after these medications.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The only symptom of overdose is typically diarrhea. Management involves symptomatic treatment and replacement of fluids and electrolytes.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed and potential benefits outweigh risks. It is unknown if UDCA is excreted in human milk; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Off-patent
Clinical Trials
Ongoing research is exploring the potential use of UDCA in other liver diseases such as Non-Alcoholic Fatty Liver Disease (NAFLD) and Cystic Fibrosis-related liver disease, as well as its role in cancer prevention in specific conditions.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, bilirubin) should be monitored every 3-6 months, especially during the first year of treatment for PBC.
- Ultrasound examinations of the gallbladder should be performed every 6-12 months for gallstone dissolution to monitor stone size and assess treatment response.
Doctor Notes
- Emphasize strict adherence to treatment for gallstone dissolution, as it requires prolonged therapy for efficacy.
- Regular monitoring of liver function tests is crucial, especially in patients with Primary Biliary Cholangitis (PBC).
- Counsel patients on the possibility of gallstone recurrence after successful dissolution and the need for continued lifestyle management.
- In PBC, UDCA has been shown to improve liver biochemistry and transplant-free survival.
Patient Guidelines
- Take Ursoren exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Report any severe or persistent diarrhea, abdominal pain, or yellowing of the skin/eyes (jaundice) to your doctor immediately.
- For gallstone dissolution, treatment can be long-term (up to 2 years or more).
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 take a double dose to make up for a missed one.
Driving Precautions
Ursoren is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or any other side effect that impairs your concentration, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy, balanced diet low in saturated fats and cholesterol.
- Regular physical activity is encouraged.
- Avoid rapid weight loss, as this can increase the risk of gallstone formation.
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