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.
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
Clinical Trials
Ursodeoxycholic acid has been extensively studied in clinical trials for its approved indications. Ongoing research explores its potential in other liver conditions and gastrointestinal disorders.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, bilirubin) should be monitored at 3-6 month intervals, especially in patients with PBC. Imaging studies (e.g., ultrasound) may be needed to monitor gallstone dissolution or progression.
Doctor Notes
- Patients should be carefully selected for gallstone dissolution therapy, excluding those with calcified stones or non-functioning gallbladders.
- Efficacy in PBC is well-established, significantly improving liver biochemistry and reducing the need for transplantation.
- Monitor liver function tests periodically for all patients on long-term therapy.
Patient Guidelines
- Take the medication consistently as prescribed, do not stop without consulting your doctor.
- Report severe or persistent diarrhea to your doctor.
- Attend all scheduled follow-up appointments and laboratory tests.
- For gallstones, treatment may take many months; efficacy decreases with larger and more calcified stones.
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 double the dose to catch up.
Driving Precautions
Ursotab is not known to affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects that impair your judgment, avoid such activities.
Lifestyle Advice
- Maintain a healthy body weight and avoid rapid weight loss.
- Follow a balanced diet, limiting foods high in cholesterol.
- Stay hydrated by drinking plenty of fluids.
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