Spusoft
Generic Name
Ursodeoxycholic Acid
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| spusoft 300 mg capsule | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Spusoft 300 mg Capsule contains Ursodeoxycholic Acid (UDCA), a naturally occurring bile acid. It is primarily used to dissolve cholesterol-rich gallstones and to treat primary biliary cholangitis (PBC), a chronic liver disease.
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, usually divided into 2-4 doses, with meals. For biliary reflux gastritis: 300 mg once daily at bedtime.
Elderly
No specific dosage adjustment required based on age, but caution is advised in patients with concomitant diseases.
Renal_impairment
No specific dosage adjustment required; UDCA is primarily excreted via the enterohepatic route.
How to Take
Take the capsule orally, whole with a glass of water, with food, usually in the evening or as directed by your doctor. Do not crush or chew the capsule.
Mechanism of Action
Ursodeoxycholic Acid reduces the cholesterol content of bile by suppressing hepatic cholesterol synthesis and secretion, leading to the dissolution of cholesterol gallstones. It also has cytoprotective, anti-apoptotic, and immunomodulatory effects, which are beneficial in chronic cholestatic liver diseases like PBC.
Pharmacokinetics
Onset
Gallstone dissolution may take several months (3-12 months). Symptomatic relief can be earlier.
Excretion
Mainly excreted in feces (up to 95%), with a small amount excreted in urine.
Half life
Approximately 3.5-5.8 days (due to enterohepatic circulation).
Absorption
Well absorbed from the gastrointestinal tract, primarily in the jejunum and ileum. Systemic bioavailability is low (around 3-6%) due to significant first-pass metabolism.
Metabolism
Undergoes extensive enterohepatic recirculation. Metabolized in the liver to glucuronide and sulfate conjugates, and further by intestinal bacteria to lithocholic acid (a toxic metabolite, which is then sulfated and excreted).
Side Effects
Contraindications
- Acute inflammation of the gallbladder or bile ducts.
- Obstruction of the biliary tract (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones.
- Impaired contractility of the gallbladder.
- Non-functioning gallbladder.
- Hypersensitivity to bile acids or any component of the formulation.
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin. Monitor ciclosporin levels.
Oral Contraceptives, Estrogens, Clofibrate
These drugs may increase hepatic cholesterol secretion and gallstone formation, counteracting the effect of UDCA.
Antacids (aluminum-containing) & Cholestyramine/Colestipol
These drugs can reduce the absorption of UDCA. Administer UDCA at least 2 hours before or after these agents.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose is rare, but may lead to diarrhea. Treatment is symptomatic and supportive. Fluid and electrolyte replacement may be necessary.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefits outweigh the risks. Excretion into breast milk is minimal, but caution should be exercised when administered to a nursing mother. Consult your doctor.
Side Effects
Contraindications
- Acute inflammation of the gallbladder or bile ducts.
- Obstruction of the biliary tract (e.g., common bile duct obstruction).
- Frequent episodes of biliary colic.
- Calcified gallstones.
- Impaired contractility of the gallbladder.
- Non-functioning gallbladder.
- Hypersensitivity to bile acids or any component of the formulation.
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin. Monitor ciclosporin levels.
Oral Contraceptives, Estrogens, Clofibrate
These drugs may increase hepatic cholesterol secretion and gallstone formation, counteracting the effect of UDCA.
Antacids (aluminum-containing) & Cholestyramine/Colestipol
These drugs can reduce the absorption of UDCA. Administer UDCA at least 2 hours before or after these agents.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose is rare, but may lead to diarrhea. Treatment is symptomatic and supportive. Fluid and electrolyte replacement may be necessary.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefits outweigh the risks. Excretion into breast milk is minimal, but caution should be exercised when administered to a nursing mother. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture.
Availability
Pharmacies nationwide
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ursodeoxycholic acid has been extensively studied in numerous clinical trials for gallstone dissolution and primary biliary cholangitis, demonstrating its efficacy and safety over decades. Ongoing research explores its potential in other cholestatic liver diseases.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, bilirubin) should be monitored every month for the first 3 months of treatment, then every 3-6 months. Gallstone size and number should be monitored by ultrasonography every 6-12 months.
Doctor Notes
- Advise patients that gallstone dissolution is a lengthy process and adherence to treatment is critical.
- Monitor liver function tests periodically, especially during the initial months of treatment for PBC.
- Educate patients on potential drug interactions, especially with antacids and cholesterol-lowering agents.
- Confirm gallbladder function and absence of calcified gallstones before initiating treatment for gallstones.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medicine without consulting your doctor, even if you feel better.
- It may take several months for gallstones to dissolve. Continue treatment for the prescribed duration.
- Inform your doctor about all other medications you are taking.
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 take a double dose to make up for a missed one.
Driving Precautions
Spusoft is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or any other side effect that affects your concentration, avoid these activities.
Lifestyle Advice
- Maintain a healthy diet low in cholesterol and saturated fats.
- Avoid excessive alcohol consumption.
- Regular exercise may support overall liver health.
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