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Ursoft Suspension (Ursodeoxycholic Acid 125 mg) by Biophar Group: Comprehensive Overview
Introduction
Ursoft Suspension, containing ursodeoxycholic acid (UDCA) 125 mg, is a widely used medication formulated by Biophar Group, Division of Biophar Lifesciences Pvt Ltd. This suspension is primarily indicated for the management of gallbladder stones, liver disorders, and bile acid regulation. UDCA is a naturally occurring bile acid that plays a crucial role in the dissolution of cholesterol-based gallstones and the improvement of liver function.
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Composition and Formulation
Ursoft Suspension is formulated as an oral liquid preparation, making it suitable for pediatric and geriatric patients who may have difficulty swallowing tablets or capsules. Each 5 ml of the suspension contains:
- Ursodeoxycholic Acid (UDCA): 125 mg
- Excipients: Sweeteners, stabilizers, and preservatives to enhance the stability and palatability of the suspension.
Mechanism of Action
Ursodeoxycholic acid works through multiple mechanisms:
- Gallstone Dissolution: UDCA reduces cholesterol secretion into the bile and improves bile flow, preventing stone formation and helping dissolve existing gallstones.
- Hepatoprotective Effects: UDCA reduces liver enzyme levels and inflammation in liver diseases like primary biliary cholangitis (PBC) and non-alcoholic fatty liver disease (NAFLD).
- Cytoprotective Action: It stabilizes hepatocyte membranes, reducing oxidative stress and preventing liver cell damage.
- Immunomodulatory Role: UDCA modulates immune responses, preventing excessive liver damage in conditions like autoimmune hepatitis.
Indications and Uses
Ursoft Suspension is commonly prescribed for:
- Gallbladder Disorders:
- Dissolution of small, non-calcified cholesterol gallstones
- Prevention of gallstone recurrence
- Liver Diseases:
- Primary biliary cholangitis (PBC)
- Non-alcoholic fatty liver disease (NAFLD)
- Alcoholic liver disease
- Hepatitis-associated cholestasis
- Pediatric Indications:
- Treatment of cholestatic liver diseases in infants and children
- Biliary atresia post-surgical management
- Cystic Fibrosis-Associated Liver Disease (CFLD)
- Drug-Induced Liver Injury Prevention: Used in cases where medications cause bile flow disturbances.
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Dosage and Administration
The dosage of Ursoft Suspension varies based on the indication, age, and weight of the patient. A general guideline is:
- For gallstones: 10-12 mg/kg/day in two to three divided doses.
- For liver diseases: 10-15 mg/kg/day as a single or divided dose.
- For Pediatric Use: Adjusted per the weight-based calculation by the physician.
- Duration: Treatment usually lasts several months to years, depending on the condition.
Administration Guidelines
- It should be taken with food to enhance absorption.
- The dosage should be followed strictly as prescribed by the healthcare provider.
- Shake the bottle well before use.
Benefits of Ursoft Suspension
- Non-invasive gallstone Treatment: Eliminates the need for surgery in select cases.
- Liver Function Improvement: Reduces liver enzymes and slows disease progression.
- Safe for Pediatric Use: Effective in infants and children with liver and biliary disorders.
- Well-Tolerated: Fewer gastrointestinal side effects compared to other bile acid therapies.
Side Effects and Precautions
Ursoft Suspension is generally well-tolerated, but some side effects may occur, including:
- Gastrointestinal Symptoms: Diarrhea, nausea, vomiting, or constipation.
- Allergic Reactions: Skin rash, itching, or swelling.
- Increased Liver Enzymes: Rare but may occur, requiring monitoring.
- Hair Loss (Rare): Temporary and reversible upon discontinuation.
Precautions and Warnings
- Contraindicated in patients with:
- Acute cholecystitis (inflammation of the gallbladder)
- Biliary obstruction
- Severe liver dysfunction (unless prescribed by a specialist)
- Calcified gallstones
- Pregnancy & Lactation: Should only be used under medical supervision.
- Regular liver function tests (LFTs) are recommended to monitor progress and prevent toxicity.
Drug Interactions
Certain medications may affect the effectiveness of Ursoft Suspension :
- Cholestyramine & Antacids (Aluminum-based): Reduce UDCA absorption.
- Ciprofloxacin & Estrogen Therapy: This may reduce the gallstone-dissolving effect.
- Ciclosporin: UDCA can alter its absorption and efficacy.
Ursoft Suspension, containing Ursodeoxycholic Acid 125 mg SUSPENSION PET 100 ML, is a widely used medication formulated by Biophar Group, Division of Biophar Lifesciences Pvt. Ltd. This suspension is primarily indicated for the management of gallbladder stones, liver disorders, and bile acid regulation.
Storage and Handling
- Store at room temperature (15°C-25°C).
- Keep away from direct sunlight and moisture.
- Shake well before each use.
- Keep out of the reach of children.
Why Choose Ursoft Suspension by Biophar Group?
- High-Quality Formulation: Ensures optimal bioavailability and efficacy.
- Trusted Manufacturer: Biophar Lifesciences Pvt Ltd is a reputed name in pharmaceutical manufacturing and is a trusted franchisee/PCD company.
- Safe and Effective: Backed by clinical research and medical recommendations.
- Pediatric-Friendly: Suitable for use in children with cholestatic liver diseases.
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Conclusion
Ursoft Suspension (Ursodeoxycholic Acid 125 mg) by Biophar Group is an effective and well-tolerated therapy for liver and gallbladder disorders. It mainly benefits patients seeking non-surgical gallstone dissolution, liver function improvement, and cholestatic disease management. With proper dosage and medical supervision, Ursoft Suspension ensures significant benefits in maintaining bile acid homeostasis and promoting liver health.
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