URSOFALK 250MG 50CAP

Benefits & Uses

Primary Benefit

Treats primary biliary cholangitis and dissolves cholesterol-rich gallstones by replacing toxic bile acids with the hydrophilic ursodeoxycholic acid.

Health Claims

Clinically proven for treatment of primary biliary cholangitis (PBC); improvement of liver function in PBC.

Common Deficiency Symptoms

Not applicable - UDCA is a therapeutic bile acid, not an essential nutrient with a recognized deficiency state.

Target Population

Adults with primary biliary cholangitis.

Scientific Evidence Level

Strong

Usage & Dosage

Suggested Use

Take 1-3 capsules daily as directed by physician, divided across meals or as a single evening dose depending on indication, swallowed whole with water.

Serving Size

1 capsule (250mg)

Servings Per Container

50

Best Time to Take

With meals in 2-4 divided doses daily for primary biliary cholangitis; single evening dose at bedtime may be used for gallstone dissolution.

Recommended Daily Intake

Adults: 8-10 mg/kg/day for gallstone dissolution; 13-15 mg/kg/day for primary biliary cholangitis, administered in divided doses.

Upper Tolerable Limit

28-30 mg/kg/day; doses above this range are associated with increased adverse effects without added therapeutic benefit.

Absorption Enhancers

Taking with food increases bile secretion and enhances enterohepatic recirculation of UDCA; adequate dietary fat supports bile acid cycling.

Absorption Inhibitors

Bile acid sequestrants (cholestyramine, colestipol) and aluminum-based antacids bind UDCA in the gut and significantly reduce absorption; separate by at least 2 hours.

Side Effects

Possible Side Effects

Diarrhea (most common, especially at high doses), pasty stools, nausea, vomiting, abdominal discomfort, pruritus, and transient elevation of liver enzymes; calcification of gallstones with prolonged use in some patients.

Toxicity Risk

Low

Upper Tolerable Limit

28-30 mg/kg/day; doses above this range are associated with increased adverse effects without added therapeutic benefit.

Safety & Warnings

Contraindications

Hypersensitivity to ursodeoxycholic acid or excipients; acute inflammation of the gallbladder or biliary tract (cholecystitis/cholangitis); complete biliary obstruction; non-functioning gallbladder or impaired gallbladder contractility; calcified (radiopaque) gallstones; frequent episodes of biliary colic when used for gallstone dissolution.

Pregnancy Safety

Consult Doctor

Interactions

Medication Interactions

Absorption reduced by bile acid sequestrants (cholestyramine, colestipol) and aluminum-based antacids. May reduce absorption of ciprofloxacin, dapsone, and nitrendipine. Effectiveness may be counteracted by estrogens, oral contraceptives, and clofibrate. Cyclosporine dose adjustment may be required as UDCA can alter its absorption.

Supplement Interactions

Calcium carbonate-based supplements and aluminum-containing antacid supplements may reduce UDCA absorption if taken simultaneously; separate by at least 2 hours.

Special Populations

Target Population

Adults with primary biliary cholangitis.

Pregnancy Safety

Consult Doctor

Storage & Patient Advice

SFDA Storage Conditions

store below 30°c

Patient Counseling

Take URSOFALK exactly as prescribed - dose is weight-based and indication-specific. Take with food to improve absorption and reduce gastrointestinal side effects. Separate from bile acid sequestrants (cholestyramine, colestipol) and aluminum-containing antacids by at least 2 hours. Do not stop therapy without medical advice as gallstones may recur. Attend regular follow-up appointments for liver function tests and ultrasound monitoring. Report persistent diarrhea, worsening jaundice, or severe abdominal pain to your prescriber immediately. This is a prescription medication and must not be self-medicated.

Science & Evidence

Bioavailability Form

Ursodeoxycholic acid (UDCA) - a naturally occurring hydrophilic secondary bile acid with approximately 70% oral bioavailability; undergoes extensive enterohepatic circulation.

Scientific Evidence Level

Strong

Food Sources

Not meaningfully present in common dietary food sources. UDCA is found in trace amounts in human bile and in high concentrations in bear bile; produced synthetically for pharmaceutical use.

Product Information

Supplement Type

Bile Acid

Plant Source

Not applicable - UDCA is a secondary bile acid produced synthetically for pharmaceutical use; it is not derived from a plant source.

Standardized Extract

Not applicable - UDCA is a single, chemically defined pharmaceutical compound (250mg per capsule), not a plant extract.