Antigall 300 Tablet

Antigall 300mg Tablet (Ursodeoxycholic Acid)

Manufacturer: Incepta Pharmaceuticals Ltd.
Generic Name: Ursodeoxycholic Acid (UDCA) 300mg
Therapeutic Class: Cholelitholytic Agent / Hepatoprotective / Bile Acid
Price: ৳22.00 per tablet

Indications

Antigall 300mg is indicated for:

• Dissolution of cholesterol gallstones: Non-calcified, radiolucent cholesterol gallstones in patients with a functioning gallbladder who are unwilling or unfit for surgery
• Primary Biliary Cholangitis (PBC): Also known as Primary Biliary Cirrhosis — slows disease progression and reduces liver enzyme elevation
• Non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD)
• Chronic active hepatitis
• Intrahepatic cholestasis of pregnancy — relieves pruritus and reduces serum bile acids
• Primary sclerosing cholangitis
• Cystic fibrosis-associated liver disease
• Prevention of gallstone recurrence after lithotripsy or surgical stone removal

The 300mg tablet provides a convenient higher-unit-dose formulation for patients requiring standard or high daily doses.

Composition

Each tablet contains: Ursodeoxycholic Acid (UDCA) 300mg

Mechanism of Action

Ursodeoxycholic acid is a naturally occurring hydrophilic bile acid that acts through multiple mechanisms:

• Cholesterol solubilisation: Reduces hepatic cholesterol synthesis and biliary cholesterol secretion; decreases intestinal cholesterol absorption; increases cholesterol solubility in bile — collectively preventing stone formation and promoting dissolution of existing cholesterol gallstones.
• Cytoprotection: Displaces hydrophobic, cytotoxic bile acids (chenodeoxycholic acid, deoxycholic acid) from the enterohepatic circulation, protecting hepatocytes and bile duct epithelial cells from membrane damage.
• Immunomodulation: Reduces aberrant MHC antigen expression on hepatocytes and biliary epithelium — important in autoimmune liver diseases such as PBC.
• Anti-apoptotic: Inhibits bile acid-induced mitochondrial apoptosis in hepatocytes and cholangiocytes.
• Choleretic: Stimulates hepatocyte bile secretion and improves bile flow, reducing intrahepatic cholestasis.

Dosage and Administration

Gallstone dissolution: 8–10 mg/kg/day in 2–3 divided doses with food, or as a single bedtime dose. Typical adult (60–80 kg): 1 tablet (300mg) twice daily, or as directed by the physician. Duration: 6–24 months; reassess by imaging at 6 months.

Primary Biliary Cholangitis (PBC): 13–15 mg/kg/day in divided doses.

NAFLD/NASH: 10–15 mg/kg/day in divided doses.

Intrahepatic cholestasis of pregnancy: 10–15 mg/kg/day in divided doses.

Note: The 300mg tablet is suitable for once- or twice-daily dosing in most adults, reducing pill burden compared to 150mg tablets. Take with food and water. Separate from aluminium hydroxide antacids by at least 2 hours.

Contraindications

• Acute inflammation of the gallbladder or bile ducts
• Frequent biliary colic
• Calcified (radio-opaque) or pigment gallstones
• Non-functioning gallbladder
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Known hypersensitivity to UDCA or any bile acid

Warnings and Precautions

• Monitor liver function tests (ALT, AST, GGT, ALP) every 4 weeks for the first 3 months, then every 3 months.
• Confirm gallstone type (cholesterol vs. pigment/calcified) by ultrasound or cholecystography before initiating therapy — UDCA is ineffective against calcified stones.
• Perform hepatobiliary imaging every 6 months during gallstone dissolution therapy to assess progress.
• After successful dissolution, gallstone recurrence is common (~50% at 5 years) — discuss maintenance therapy or preventive measures with the physician.
• In advanced cirrhosis, bile acid therapy may precipitate liver decompensation — use with extreme caution.

Side Effects

Common: Diarrhoea (dose-related, particularly at higher doses), nausea, abdominal discomfort or pain.

Uncommon: Urticaria, pruritus, alopecia.

Rare: Calcification of existing gallstones (if non-cholesterol components are present); liver decompensation in pre-existing cirrhosis.

UDCA has an excellent tolerability profile and is significantly better tolerated than chenodeoxycholic acid.

Drug Interactions

• Antacids (aluminium hydroxide) and bile acid sequestrants (cholestyramine, colestipol): Bind UDCA in the intestine and reduce absorption — separate by at least 2 hours.
• Clofibrate, oral contraceptives, oestrogens: Increase biliary cholesterol and may counteract the stone-dissolving effect of UDCA.
• Cyclosporin: UDCA increases cyclosporin intestinal absorption — monitor blood levels and adjust cyclosporin dose if necessary.
• Ciprofibrate: UDCA may increase plasma levels of ciprofibrate.

Use in Pregnancy and Lactation

Pregnancy: UDCA is a first-line treatment for intrahepatic cholestasis of pregnancy (ICP) and has a well-documented safety record in this indication. Use only under physician supervision for other indications during pregnancy.

Lactation: Small amounts may be excreted in breast milk — use with caution and only when clinically necessary.

Storage

Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.

Pricing

Antigall 300mg Tablet: ৳22.00 per tablet

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.