Udkag 300

UdKag 300 mg Tablets

UdKag (Ursodeoxycholic Acid, UDCA) is a bile acid indicated for the dissolution of radiolucent cholesterol gallstones and for cholestatic liver disorders such as primary biliary cholangitis (PBC). UDCA reduces cholesterol saturation in bile, enhances bile flow, and protects hepatocytes from cytotoxic bile acids.

Key Features

• IP-grade UDCA 300 mg for convenient dosing
• Uncoated tablet designed for reliable disintegration and absorption
• 10×10 bulk pack for hospital and clinic use
• Consistent quality with tightly controlled excipient profile

Indications

• Dissolution of radiolucent (non-calcified) cholesterol gallstones in a functioning gallbladder
• Primary biliary cholangitis (PBC)
• Adjunct in other cholestatic liver diseases as directed by a physician
• Biliary reflux gastritis (as clinically appropriate)

Dosage & Administration*

• Gallstone dissolution: ~8–10 mg/kg/day, in 1–2 divided doses after meals
• PBC / cholestatic disorders: 13–15 mg/kg/day, in 2–3 divided doses after meals
• Administration: Swallow whole with water, preferably after food. Duration depends on indication and clinical response.
  *Doses are general guidance; individualize as per physician’s judgement.

Mechanism of Action (MOA)

UDCA replaces more hydrophobic bile acids, reduces cholesterol absorption and secretion into bile, decreases biliary cholesterol saturation, and improves bile flow (choleresis), thereby protecting cholangiocytes and hepatocytes.

Contraindications

• Hypersensitivity to UDCA or any excipient
• Calcified/radiopaque gallstones, non-functioning gallbladder
• Acute cholecystitis, complete biliary obstruction, acute cholangitis, biliary-enteric fistula
• Pregnancy and lactation: use only if clearly needed and prescribed

Warnings & Precautions

• Periodic monitoring of liver function tests recommended during therapy
• Assess gallbladder function and stone composition/visibility prior to initiation
• Discontinue if persistent elevation of transaminases or intolerable GI symptoms occur

Adverse Effects

Generally, well tolerated. Possible: diarrhea, soft stools, nausea, abdominal pain, pruritus, rash, rarely elevated transaminases or calcification of stones.

Drug Interactions

• Bile acid sequestrants (e.g., cholestyramine), antacids with aluminum, and activated charcoal may reduce UDCA absorption—separate doses by ≥2 hours.
• Ciprofloxacin, cyclosporine, estrogenic contraceptives, lipid-lowering agents: monitor as they may alter bile composition or UDCA levels.

Storage

Store below 25°C, protected from light and moisture. Keep out of reach of children.

Packaging

Alu-Alu/Blister* packs of 10×10 tablets (100 tablets per mono-carton).
*Specify exact pack material as per your final spec.

Regulatory Status (India)

Schedule H prescription drug. To be sold by retail on the prescription of a Registered Medical Practitioner only.