Cynogen Ursodeoxycholic Acid Oral Suspension

1. Indications and Usage
Cholesterol Gallstones:
Indicated for the dissolution of cholesterol gallstones in patients with radiolucent, functioning gallbladders who are not candidates for surgery.
Primary Biliary Cholangitis (PBC):
Indicated for the treatment of primary biliary cholangitis (formerly primary biliary cirrhosis).
Cystic Fibrosis-Associated Liver Disease (CF-LD):
Indicated for the treatment of liver disease associated with cystic fibrosis.
Bile Reflux Gastritis:
Indicated for the treatment of bile reflux gastritis.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY. Shake well before use.
Recommended Dosage:
Cholesterol Gallstones: 8–10 mg/kg/day, taken at bedtime (with or without food).
Primary Biliary Cholangitis (PBC): 13–15 mg/kg/day, administered in 2–4 divided doses.
Cystic Fibrosis-Associated Liver Disease: 20–30 mg/kg/day, administered in 2–4 divided doses.
Bile Reflux Gastritis: 250 mg once daily at bedtime.
Administration Instructions:
Use the supplied measuring device (syringe or spoon) to ensure accurate dosing.
Suspension can be diluted with water or juice if the taste is unacceptable.
3. Mechanism of Action
Choleresis:
Ursodeoxycholic acid (UDCA) is a hydrophilic bile acid that stimulates bile secretion (choleresis) by the liver.
Inhibition of Cholesterol Absorption:
It reduces the absorption of cholesterol from the intestine and decreases the secretion of cholesterol into the bile, thereby reducing the cholesterol saturation index in bile.
Cytoprotection:
It replaces toxic, hydrophobic bile acids in the biliary tree and protects hepatocytes from bile acid-induced cytotoxicity.
4. Safety and Warnings
Contraindications:
Acute inflammation of the gallbladder or bile ducts.
Radiopaque (calcified) gallstones.
Non-functioning gallbladder.
Severe hepatic impairment or biliary obstruction.
Monitoring:
Monitor liver function tests (ALT, AST, GGT) at regular intervals.
Monitor gallstone status via ultrasound every 6 months.
5. Adverse Reactions
Most Common:
Diarrhea, nausea, vomiting, constipation, and pruritus.
6. Drug Interactions
Cholesterol-Lowering Drugs:
Drugs like colestyramine, colestipol, and aluminum-based antacids may bind to UDCA in the gut and prevent its absorption. Avoid concomitant use.
Cyclosporine:
UDCA may increase the intestinal absorption of cyclosporine. Monitor cyclosporine levels.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ursodeoxycholic Acid.
Excipients: Xylitol, Glycerol, Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Propylene Glycol, Sodium Citrate, Sodium Cyclamate, Anhydrous Citric Acid, Sodium Chloride, Lemon Flavor, Purified Water.
Storage:
Store at room temperature (do not exceed 25°C). Do not freeze. Protect from light.