Ursodex
Generic Name
Ursodeoxycholic Acid
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursodex 300 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used to dissolve cholesterol gallstones and treat certain liver diseases, such as primary biliary cholangitis (PBC). It works by reducing the amount of cholesterol produced by the liver and absorbed by the intestines, thus helping to dissolve cholesterol gallstones and reduce bile toxicity in liver disorders.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day in 2-3 divided doses, for up to 2 years. For PBC: 13-15 mg/kg/day in 2-4 divided doses, initially and then adjusted based on response.
Elderly
No specific dosage adjustment is generally required, but close monitoring of liver function is recommended.
Renal_impairment
No specific dosage adjustment for mild to moderate impairment. Use with caution in severe cases due to lack of extensive data.
How to Take
Take orally with food, usually in the evening or divided into 2-3 doses. Tablets should be swallowed whole with water.
Mechanism of Action
UDCA works by altering the composition of bile, reducing its cholesterol saturation. This allows cholesterol gallstones to dissolve. In liver diseases like PBC, UDCA is thought to protect liver cells from toxic bile acids, improve bile flow, and exert immunomodulatory effects.
Pharmacokinetics
Onset
Gallstone dissolution may take 6 months to 2 years. Symptomatic relief in PBC may take several weeks.
Excretion
Primarily excreted in feces via bile.
Half life
Approximately 3.5 to 5.8 days (for endogenous UDCA recirculated).
Absorption
Well absorbed (approximately 90%) from the gastrointestinal tract.
Metabolism
Undergoes extensive enterohepatic recirculation. Conjugated in the liver with glycine or taurine.
Side Effects
Contraindications
- Acute inflammation of the gallbladder or bile ducts (acute cholecystitis or cholangitis).
- Obstruction of the bile ducts (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones or non-cholesterol gallstones.
- Impaired contractility of the gallbladder.
- Hypersensitivity to bile acids or any component of the tablet.
Drug Interactions
Dapsone, Warfarin
UDCA may potentially increase the absorption of these drugs.
Oral Contraceptives or Estrogens
May increase cholesterol secretion into bile, potentially counteracting the effect of UDCA.
Clofibrate and other lipid-lowering agents
May increase cholesterol secretion into bile, reducing the efficacy of UDCA.
Cholestyramine, Colestipol, or aluminum hydroxide-containing antacids
These agents bind UDCA and reduce its absorption. Administer at least 2 hours apart.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most common symptom of overdose is diarrhea. Management involves symptomatic treatment and discontinuation of the drug. Large doses may lead to liver enzyme elevations.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of fetal harm, but human data are limited. Use only if clearly needed and benefits outweigh risks. UDCA is excreted into breast milk in very small amounts; generally considered safe but consult a doctor.
Side Effects
Contraindications
- Acute inflammation of the gallbladder or bile ducts (acute cholecystitis or cholangitis).
- Obstruction of the bile ducts (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones or non-cholesterol gallstones.
- Impaired contractility of the gallbladder.
- Hypersensitivity to bile acids or any component of the tablet.
Drug Interactions
Dapsone, Warfarin
UDCA may potentially increase the absorption of these drugs.
Oral Contraceptives or Estrogens
May increase cholesterol secretion into bile, potentially counteracting the effect of UDCA.
Clofibrate and other lipid-lowering agents
May increase cholesterol secretion into bile, reducing the efficacy of UDCA.
Cholestyramine, Colestipol, or aluminum hydroxide-containing antacids
These agents bind UDCA and reduce its absorption. Administer at least 2 hours apart.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most common symptom of overdose is diarrhea. Management involves symptomatic treatment and discontinuation of the drug. Large doses may lead to liver enzyme elevations.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of fetal harm, but human data are limited. Use only if clearly needed and benefits outweigh risks. UDCA is excreted into breast milk in very small amounts; generally considered safe but consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Ursodeoxycholic acid has been extensively studied in clinical trials for gallstone dissolution, primary biliary cholangitis, and other cholestatic liver diseases, demonstrating efficacy and safety over decades of use. Ongoing research explores its potential in other liver conditions.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, bilirubin) should be monitored every 1-3 months during the first year of treatment, and then every 6 months.
- For gallstone dissolution, ultrasound of the gallbladder should be performed every 6-12 months to monitor stone size and assess gallbladder function.
Doctor Notes
- Emphasize the importance of patient compliance for the long duration of treatment, especially for gallstone dissolution.
- Advise patients about the potential for diarrhea and to report severe or persistent symptoms.
- Regularly assess liver function and response to treatment, adjusting dosage as needed based on clinical and laboratory parameters.
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.
- Inform your doctor about any new or worsening symptoms or side effects.
- Regular monitoring of liver function tests and ultrasound 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 continue 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.
Lifestyle Advice
- Maintain a healthy, low-cholesterol diet.
- Regular physical activity is beneficial.
- Limit alcohol consumption, as it can affect liver health.
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