Ursotab
Generic Name
Ursodeoxycholic Acid 300 mg Tablet
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursotab 300 mg tablet | ৳ 35.02 | ৳ 350.20 |
Description
Overview of the medicine
Ursotab 300 mg Tablet contains Ursodeoxycholic Acid (UDCA), a naturally occurring bile acid. It is used to dissolve certain types of gallstones and to treat primary biliary cholangitis (PBC). UDCA is also used in children with cystic fibrosis-related hepatobiliary disorders.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually taken as a single dose at bedtime. For PBC: 13-15 mg/kg/day, divided into 2-4 doses.
Elderly
Similar to adult dosage; no specific adjustments required unless severe comorbidities are present. Caution advised.
Renal_impairment
No dosage adjustment needed, as it is primarily eliminated via feces.
How to Take
Take orally with food. For gallstone dissolution, a single dose at bedtime is often recommended. For PBC, doses are usually divided and taken with meals. Swallow tablets whole with water; do not chew.
Mechanism of Action
Ursodeoxycholic acid suppresses hepatic synthesis and secretion of cholesterol, thereby lowering its saturation in bile. It also changes the composition of bile from lithogenic to non-lithogenic, facilitating the dissolution of cholesterol gallstones. In cholestatic liver diseases, it replaces toxic bile acids, protects liver cells from damage, and improves bile flow.
Pharmacokinetics
Onset
Gallstone dissolution may take several months to years. Symptomatic improvement in PBC may be observed within weeks to months.
Excretion
Primarily excreted in feces (as conjugates or metabolites). Minimal renal excretion.
Half life
Approximately 3-6 days, due to enterohepatic recirculation.
Absorption
Well absorbed from the gastrointestinal tract (about 90%). Undergoes extensive enterohepatic recirculation.
Metabolism
Extensively conjugated in the liver with glycine and taurine, excreted into bile.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Acute inflammation of the gallbladder or bile ducts
- Occlusion of the bile duct (e.g., common bile duct obstruction)
- Frequent episodes of biliary colic
- Calcified cholesterol gallstones, radio-opaque gallstones
- Non-functioning gallbladder
Drug Interactions
Estrogens, Oral contraceptives, Clofibrate
Can increase cholesterol saturation in bile, counteracting UDCA's effect. Avoid concomitant use if possible for gallstone dissolution.
Ciclosporin, Dapsone, Ciprofloxacin, Nitrendipine
UDCA may reduce the absorption of these drugs, potentially decreasing their efficacy. Monitor levels and adjust dosage if necessary.
Cholestyramine, Colestipol, Aluminum hydroxide-containing antacids
These can bind UDCA and reduce its absorption. Administer at least 1 hour apart from UDCA.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may cause diarrhea. In general, other symptoms of overdose are unlikely as the absorption of UDCA decreases with increasing dose. Treatment is symptomatic, and no specific antidote is known. Discontinuation of the drug is usually sufficient.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but human data are limited. Use only if clearly needed and the potential benefits outweigh the risks. Excreted in breast milk in small amounts, generally considered safe but caution is advised; consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Acute inflammation of the gallbladder or bile ducts
- Occlusion of the bile duct (e.g., common bile duct obstruction)
- Frequent episodes of biliary colic
- Calcified cholesterol gallstones, radio-opaque gallstones
- Non-functioning gallbladder
Drug Interactions
Estrogens, Oral contraceptives, Clofibrate
Can increase cholesterol saturation in bile, counteracting UDCA's effect. Avoid concomitant use if possible for gallstone dissolution.
Ciclosporin, Dapsone, Ciprofloxacin, Nitrendipine
UDCA may reduce the absorption of these drugs, potentially decreasing their efficacy. Monitor levels and adjust dosage if necessary.
Cholestyramine, Colestipol, Aluminum hydroxide-containing antacids
These can bind UDCA and reduce its absorption. Administer at least 1 hour apart from UDCA.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may cause diarrhea. In general, other symptoms of overdose are unlikely as the absorption of UDCA decreases with increasing dose. Treatment is symptomatic, and no specific antidote is known. Discontinuation of the drug is usually sufficient.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but human data are limited. Use only if clearly needed and the potential benefits outweigh the risks. Excreted in breast milk in small amounts, generally considered safe but caution is advised; consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available; original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of UDCA for gallstone dissolution and PBC. Ongoing research explores its role in other cholestatic and liver diseases, including non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) with varying results.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin, GGT) at regular intervals (e.g., every 4 weeks for the first 3 months, then every 3 months), especially during the first few months of PBC treatment.
- Monitoring of gallstone size and number by ultrasound every 6-12 months during dissolution therapy.
Doctor Notes
- Confirm cholesterol gallstones before initiating therapy (non-calcified, radio-lucent).
- Monitor liver function tests regularly (every 1-3 months), especially in PBC patients, and adjust treatment if necessary.
- Advise patients on the long duration of treatment required for gallstone dissolution and the importance of adherence.
- Not effective for calcified gallstones or in patients with non-functioning gallbladders.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Ursotab without consulting your doctor, even if you feel better.
- Report any unusual or severe side effects to your doctor immediately.
- For gallstone dissolution, treatment may be long-term (up to 2 years or more).
- Store at room temperature away from moisture and heat.
Missed Dose Advice
If a dose is missed, 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 impair the ability to drive or operate machinery. However, if you experience dizziness or any other side effect that might affect your concentration, avoid these activities.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Avoid rapid weight loss, as it can promote gallstone formation.
- Limit intake of cholesterol-rich foods if you are being treated for gallstones.
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