Ursocol
Generic Name
Ursodeoxycholic Acid
Manufacturer
Cipla Ltd.
Country
India
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ursocol 150 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Ursocol 150 mg tablet contains Ursodeoxycholic Acid, a naturally occurring bile acid. It is used to dissolve certain types of gallstones and treat primary biliary cholangitis (PBC).
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually divided into 2-3 doses, taken with meals. For PBC: 13-15 mg/kg/day, divided into 2-4 doses.
Elderly
No specific dose adjustment is generally required, but caution is advised in patients with severe hepatic or renal impairment.
Renal_impairment
No dose adjustment needed as it is primarily eliminated via bile.
How to Take
Administer orally with food. For gallstone dissolution, a single dose at bedtime is sometimes preferred to maximize bile saturation.
Mechanism of Action
Ursodeoxycholic acid suppresses hepatic cholesterol synthesis and secretion, thereby decreasing the cholesterol saturation of bile. It also modifies the composition of bile by increasing the proportion of ursodeoxycholic acid, which is less toxic than other bile acids, protecting liver cells.
Pharmacokinetics
Onset
Gallstone dissolution may take several months to years. Symptomatic relief in PBC may be observed within weeks.
Excretion
Excreted primarily in feces, mainly as unconjugated UDCA and its metabolites.
Half life
Approximately 3.5-5.8 hours.
Absorption
Well absorbed orally, about 90%.
Metabolism
Undergoes extensive enterohepatic recirculation. Metabolized in the liver to conjugated forms (glycine and taurine conjugates) and also undergoes bacterial degradation in the intestine.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Calcified cholesterol stones, radio-opaque gallstones, or pigmented gallstones
- Acute cholecystitis, cholangitis, or other acute gallbladder conditions
- Non-functioning gallbladder
- Biliary tract obstruction
- Severe hepatic impairment or chronic liver disease
Drug Interactions
Dapsone
UDCA may decrease dapsone absorption.
Ciclosporin
UDCA may increase ciclosporin absorption; monitor levels.
Estrogens, Oral Contraceptives, Clofibrate
May increase hepatic cholesterol secretion, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (aluminum-containing)
Reduce absorption of UDCA. Administer UDCA at least 1 hour before or 4-6 hours after.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose is generally not life-threatening. Diarrhea may be the predominant symptom. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Excreted in breast milk in very small amounts; generally considered compatible with breastfeeding, but consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Calcified cholesterol stones, radio-opaque gallstones, or pigmented gallstones
- Acute cholecystitis, cholangitis, or other acute gallbladder conditions
- Non-functioning gallbladder
- Biliary tract obstruction
- Severe hepatic impairment or chronic liver disease
Drug Interactions
Dapsone
UDCA may decrease dapsone absorption.
Ciclosporin
UDCA may increase ciclosporin absorption; monitor levels.
Estrogens, Oral Contraceptives, Clofibrate
May increase hepatic cholesterol secretion, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (aluminum-containing)
Reduce absorption of UDCA. Administer UDCA at least 1 hour before or 4-6 hours after.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose is generally not life-threatening. Diarrhea may be the predominant symptom. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Excreted in breast milk in very small amounts; generally considered compatible with breastfeeding, but consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA and international regulatory bodies
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established UDCA's efficacy in gallstone dissolution and PBC management. Ongoing research explores its role in other liver diseases.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) at baseline and every 3-6 months for PBC patients.
- Ultrasound of gallbladder every 6-12 months during gallstone dissolution therapy.
Doctor Notes
- Regular monitoring of liver function tests is crucial, especially in PBC patients.
- Gallstone dissolution therapy requires long-term commitment and regular ultrasound follow-up.
- Ensure patient has a functioning gallbladder before initiating therapy for gallstones.
Patient Guidelines
- Take Ursocol as prescribed by your doctor.
- Do not stop the medication without consulting your doctor, even if symptoms improve.
- Report any unusual or severe side effects to your doctor.
- For gallstone dissolution, treatment may be prolonged (months to years).
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose.
Driving Precautions
Ursocol is not known to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain a healthy, balanced diet.
- Avoid excessive intake of cholesterol-rich foods.
- Regular exercise is beneficial.
- Consult your doctor before making significant dietary changes.
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