Ursoren
Generic Name
Ursodeoxycholic Acid
Manufacturer
Various manufacturers (specific to Ursoren brand depends on country, often locally produced)
Country
Bangladesh (for local brands), Germany (for Ursofalk)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursoren 300 mg tablet | ৳ 25.00 | ৳ 150.00 |
Description
Overview of the medicine
Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used to dissolve certain types of gallstones and to treat primary biliary cholangitis (PBC). It works by reducing the amount of cholesterol produced by the liver and absorbed by the intestines, which helps to break down cholesterol gallstones. For PBC, it helps improve bile flow and protect liver cells.
Uses & Indications
Dosage
Adults
Gallstone dissolution: 8-10 mg/kg/day, usually as a single dose at bedtime or divided into 2 doses. Primary Biliary Cholangitis (PBC): 13-15 mg/kg/day, divided into 2-4 doses. Cystic Fibrosis: 20 mg/kg/day divided into 2-3 doses (up to 30 mg/kg/day if necessary).
Elderly
No specific dose adjustment is generally required, but caution is advised in patients with severe underlying conditions.
Renal_impairment
No dose adjustment is necessary as UDCA is primarily eliminated via bile, not kidneys.
How to Take
Take orally with food. For gallstone dissolution, a single evening dose at bedtime is often preferred. For PBC, doses should be divided throughout the day. Swallow tablets whole with water; do not crush or chew.
Mechanism of Action
UDCA is incorporated into the enterohepatic circulation, suppressing hepatic cholesterol synthesis and secretion, thereby reducing cholesterol saturation of bile. This promotes the dissolution of cholesterol gallstones. In chronic cholestatic liver diseases like PBC, UDCA has cytoprotective, anti-apoptotic, and immunomodulatory effects, improving bile flow and liver function.
Pharmacokinetics
Onset
Gallstone dissolution: Months to years. Symptomatic improvement in PBC: Weeks to months.
Excretion
Primarily excreted in the feces via biliary secretion. A very small amount is excreted in urine.
Half life
Approximately 3.5 to 5.8 days (after chronic administration).
Absorption
Rapidly absorbed from the gastrointestinal tract (approximately 90%), but undergoes significant first-pass hepatic extraction (about 50%).
Metabolism
Undergoes extensive enterohepatic recirculation. Metabolized in the liver to various conjugated and unconjugated forms. Gut bacteria further metabolize it.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any components of the formulation.
- Acute inflammation of the gallbladder or biliary tract.
- Occlusion of the biliary tract (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
Drug Interactions
Oral hypoglycemic agents
UDCA may alter glucose metabolism, requiring closer monitoring in diabetic patients.
Cyclosporine, Dapsone, Nitrendipine
UDCA may increase the absorption or affect the metabolism of these drugs; monitor levels and adjust doses as needed.
Estrogens, Oral Contraceptives, Clofibrate
May increase hepatic cholesterol secretion and gallstone formation, counteracting UDCA's effects.
Cholestyramine, Colestipol, Aluminum Hydroxide-containing antacids
These agents bind bile acids and reduce UDCA absorption; take UDCA at least 2 hours before or after these drugs.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most likely symptom of overdose is diarrhea. Treatment is symptomatic. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm, but adequate and well-controlled studies in pregnant women are lacking. Should be used during pregnancy only if clearly needed. UDCA is excreted into breast milk in very low concentrations; generally considered compatible with breastfeeding, but caution is advised.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any components of the formulation.
- Acute inflammation of the gallbladder or biliary tract.
- Occlusion of the biliary tract (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
Drug Interactions
Oral hypoglycemic agents
UDCA may alter glucose metabolism, requiring closer monitoring in diabetic patients.
Cyclosporine, Dapsone, Nitrendipine
UDCA may increase the absorption or affect the metabolism of these drugs; monitor levels and adjust doses as needed.
Estrogens, Oral Contraceptives, Clofibrate
May increase hepatic cholesterol secretion and gallstone formation, counteracting UDCA's effects.
Cholestyramine, Colestipol, Aluminum Hydroxide-containing antacids
These agents bind bile acids and reduce UDCA absorption; take UDCA at least 2 hours before or after these drugs.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most likely symptom of overdose is diarrhea. Treatment is symptomatic. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm, but adequate and well-controlled studies in pregnant women are lacking. Should be used during pregnancy only if clearly needed. UDCA is excreted into breast milk in very low concentrations; generally considered compatible with breastfeeding, but caution is advised.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved (by DGDA and other major regulatory bodies globally for UDCA)
Patent Status
Off-patent (generic available)
Clinical Trials
Ongoing trials investigate UDCA's role in other cholestatic liver diseases, non-alcoholic fatty liver disease (NAFLD), and as an adjunct therapy in certain cancers, though primary indications remain gallstones and PBC.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, Bilirubin) at baseline and every 1-3 months for the first 6 months, then every 6 months for PBC patients. Ultrasound monitoring of gallstones every 6-12 months for dissolution therapy.
Doctor Notes
- Emphasize the importance of consistent long-term therapy for gallstone dissolution and PBC management.
- Regular monitoring of liver function tests and imaging (ultrasound) is crucial for assessing efficacy and detecting potential complications.
- Counsel patients on potential interactions with bile acid sequestrants and certain lipid-lowering agents.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Report any severe diarrhea or persistent abdominal discomfort to your doctor.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Ursodeoxycholic Acid is not known to affect the ability to drive or operate machinery. However, if you experience dizziness or fatigue, avoid such activities.
Lifestyle Advice
- Maintain a balanced diet and regular exercise to support overall liver health.
- Avoid rapid weight loss, which can exacerbate gallstone formation.
- Limit consumption of fatty foods.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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