Ursotab
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 |
|---|---|---|
| ursotab 150 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Ursodeoxycholic Acid is a naturally occurring bile acid used to dissolve cholesterol gallstones, and to treat primary biliary cholangitis (PBC) and other cholestatic liver diseases. It works by reducing the cholesterol content of bile, thus helping to dissolve stones, and by protecting liver cells.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually taken in 2-3 divided doses. For PBC: 13-15 mg/kg/day, taken in 2-4 divided doses with food.
Elderly
No specific dose adjustment is generally required, but caution should be exercised in patients with significant comorbidities.
Renal_impairment
No dose adjustment is required in patients with renal impairment, as UDCA is primarily excreted in feces.
How to Take
Take orally, with food. For gallstone dissolution, it is often recommended to take a portion of the daily dose in the evening or at bedtime.
Mechanism of Action
Ursodeoxycholic acid (UDCA) works by replacing more toxic bile acids, reducing the saturation of cholesterol in bile, leading to the dissolution of cholesterol gallstones. It also exhibits cytoprotective, immunomodulatory, and anti-inflammatory effects, which are beneficial in cholestatic liver diseases like PBC.
Pharmacokinetics
Onset
Gallstone dissolution takes months (e.g., 6-24 months). Symptomatic relief may be earlier.
Excretion
Mainly excreted in feces (about 50-70%), with a small amount excreted in urine.
Half life
Approximately 3-5 days in the enterohepatic circulation.
Absorption
Well absorbed from the gastrointestinal tract (approximately 90%).
Metabolism
Primarily hepatic, undergoing conjugation with glycine and taurine, followed by enterohepatic recirculation.
Side Effects
Contraindications
- •Known hypersensitivity to bile acids or any component of the formulation.
- •Acute cholecystitis, cholangitis, or other inflammatory conditions of the gallbladder or bile ducts.
- •Calcified cholesterol stones, radiopaque gallstones, or pigment gallstones.
- •Non-functioning gallbladder.
- •Biliary obstruction (e.g., common bile duct obstruction).
- •Frequent episodes of biliary colic.
Drug Interactions
Ciclosporin
UDCA may increase the absorption of ciclosporin. Monitor ciclosporin levels.
Dapsone, Nitrendipine
UDCA may increase the absorption of these drugs. Monitor for increased effects.
Cholestyramine, Colestipol
May bind to UDCA in the intestine, reducing its absorption and efficacy. Administer UDCA at least 2 hours before or 4 hours after these agents.
Antacids (aluminum-containing)
May reduce the absorption of UDCA. Administer at least 2 hours apart.
Estrogens, Oral contraceptives, Clofibrate
May increase cholesterol secretion in bile, counteracting the effect of UDCA.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely symptom of overdose is diarrhea. Treatment is symptomatic, and no specific antidote is available. Increase fluid intake to prevent dehydration.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but human data is limited. Use only if clearly needed and potential benefits outweigh risks. Small amounts excreted in breast milk; generally considered compatible with breastfeeding, but consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, check packaging for exact date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available, patents expired
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Global Brand Names
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