Ursoglen
Generic Name
Ursodeoxycholic Acid
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursoglen 300 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Ursoglen 300 mg Tablet contains Ursodeoxycholic Acid, a naturally occurring bile acid used to treat gallstones and certain liver conditions like primary biliary cholangitis.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually in 2-3 divided doses. For PBC: 13-15 mg/kg/day, in 2-4 divided doses with meals.
Elderly
No specific dosage adjustment required, but caution is advised in elderly patients with significant comorbidities.
Renal_impairment
No dosage adjustment needed as UDCA is not significantly renally eliminated. Use with caution in severe cases due to potential fluid retention.
How to Take
Take orally with meals. Tablets should be swallowed whole with water and not crushed or chewed. For gallstone dissolution, take before bedtime.
Mechanism of Action
Ursodeoxycholic acid (UDCA) works by reducing the cholesterol saturation of bile, thereby facilitating the dissolution of cholesterol gallstones. It also protects liver cells from toxic bile acids by increasing the proportion of less toxic UDCA in the bile acid pool and by modulating immune responses in chronic cholestatic liver diseases.
Pharmacokinetics
Onset
Gallstone dissolution may take several months; symptomatic improvement in PBC can be seen in weeks.
Excretion
Mainly excreted in faeces (unabsorbed UDCA) and urine (metabolites).
Half life
Approximately 3.5 to 5.8 days.
Absorption
Well absorbed from the gastrointestinal tract (approximately 90% in the small intestine).
Metabolism
Undergoes extensive enterohepatic recirculation. Conjugated with glycine and taurine in the liver, then excreted into bile. Small amounts are metabolized by gut bacteria.
Side Effects
Contraindications
- Acute cholecystitis
- Obstruction of the biliary tract
- Calcified radiopaque gallstones
- Non-functioning gallbladder
- Frequent episodes of biliary colic
- Severe liver disease not amenable to UDCA treatment
Drug Interactions
Cyclosporine
UDCA may increase cyclosporine absorption; monitor cyclosporine levels.
Cholestyramine, Colestipol
May bind UDCA and reduce its absorption. Administer at least 2 hours apart.
Antacids (aluminum-containing)
May reduce absorption of UDCA. Administer at least 2 hours apart.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation of bile, counteracting UDCA's effect.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include diarrhea. Treatment is symptomatic and supportive. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Lactation: It is not known whether UDCA is excreted in human milk. Exercise caution when administering to a nursing mother.
Side Effects
Contraindications
- Acute cholecystitis
- Obstruction of the biliary tract
- Calcified radiopaque gallstones
- Non-functioning gallbladder
- Frequent episodes of biliary colic
- Severe liver disease not amenable to UDCA treatment
Drug Interactions
Cyclosporine
UDCA may increase cyclosporine absorption; monitor cyclosporine levels.
Cholestyramine, Colestipol
May bind UDCA and reduce its absorption. Administer at least 2 hours apart.
Antacids (aluminum-containing)
May reduce absorption of UDCA. Administer at least 2 hours apart.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation of bile, counteracting UDCA's effect.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include diarrhea. Treatment is symptomatic and supportive. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Lactation: It is not known whether UDCA is excreted in human milk. Exercise caution when administering to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved
Patent Status
Patent Expired (Generic available)
WHO Essential Medicine
YesClinical Trials
Extensively studied in clinical trials for gallstone dissolution and PBC, demonstrating efficacy and safety. Ongoing research explores its role in other cholestatic liver diseases and non-alcoholic fatty liver disease (NAFLD).
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, Bilirubin) at baseline and periodically (e.g., every 3-6 months) during treatment, especially for PBC.
- Serum cholesterol levels (for gallstone patients).
Doctor Notes
- Advise patients that gallstone dissolution is a lengthy process and requires consistent medication adherence.
- Monitor liver function tests regularly, especially in PBC patients.
- Inform patients about potential for diarrhea and advise on managing it.
- Consider potential drug interactions, especially with antacids and cholesterol-lowering agents.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medication without consulting your doctor.
- Report any severe or persistent side effects to your doctor.
- For gallstone dissolution, treatment may last for several months or even years.
- Maintain a balanced diet and avoid high-cholesterol foods.
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Ursodeoxycholic acid is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Adopt a healthy diet low in saturated fats and cholesterol.
- Regular physical activity.
- Avoid rapid weight loss, as it can increase the risk of gallstone formation.
- Stay hydrated.
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