Adult: 12-16 mg/kg daily in 2-3 divided doses for the 1st 3 months, then may be given once daily in the evening thereafter. Dose reduction or treatment discontinuation may be required according to individual safety and tolerability. Dosage recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Hepatobiliary disorder associated with cystic fibrosis
Child: As oral susp: ≥1 month 20 mg/kg daily in 2-3 divided doses; may increase to 30 mg/kg daily if necessary. As tab, cap or oral susp: ≥6 years 20 mg/kg daily in 2-3 divided doses; may increase to 30 mg/kg daily if necessary. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Dissolution of cholesterol-rich gallstones
Adult: In patients with functioning gallbladder: 8-12 mg/kg daily as a single dose at bedtime or in 2 divided doses for up to 2 years depending on stone size and composition. Treatment must be continued for 3-4 months after radiological disappearance of the stones. Dosage recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Prophylaxis of gallstones in patients undergoing rapid weight loss
Adult: As cap: 300 mg bid. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Ursodeoxycholic acid in Malaysia?
Ursofalk
Administration
Ursodeoxycholic acid Should be taken with food.
Contraindications
Acute inflammation of the gallbladder or biliary tract, occlusion of the common bile duct or cystic duct, frequent episodes of biliary colic; impaired contractility of the gallbladder, non-functioning gallbladder; calcified cholesterol stones, radiopaque stones or radiolucent bile pigment stones; hepatic and intestinal conditions interfering with enterohepatic recirculation of bile acids (e.g. extrahepatic and intrahepatic cholestasis, ileal resection, regional ileitis, ileal stoma); unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia (when used for hepatobiliary disorder associated with cystic fibrosis).
Special Precautions
Patient with non-visualising gallbladder; predisposition to intestinal stenosis or stasis (e.g. surgical enteroanastomosis, Crohn's disease). Children. Pregnancy and lactation.
Adverse Reactions
Significant: Biliary obstruction; enteroliths or stone formation within the bile ducts or small intestine lumen, which may lead to obstruction, localised inflammation and infection; persistent diarrhoea. Very rarely, decompensation of hepatic cirrhosis (when used for advanced stage primary biliary cholangitis [PBC]). Gastrointestinal disorders: Nausea, vomiting, constipation, dyspepsia. Very rarely, severe right upper abdominal pain (when used for PBC). Hepatobiliary disorders: Very rarely, calcification of gallstones. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Dizziness, headache. Respiratory, thoracic and mediastinal disorders: URTI. Skin and subcutaneous tissue disorders: Pruritus. Very rarely, urticaria.
Women of childbearing potential must use a reliable non-hormonal contraception during treatment.
Monitoring Parameters
Evaluate pregnancy status before treatment initiation. Monitor LFTs (e.g. AST, ALT, GGT, alkaline phosphatase) and bilirubin levels monthly during the 1st 3 months of therapy and every 3-6 months thereafter or as clinically indicated. Perform oral cholecystography and gallbladder ultrasound 6-10 months after treatment initiation (when used for the dissolution of cholesterol gallstones). Assess for signs of obstructive gastrointestinal symptoms.
Overdosage
Symptoms: Diarrhoea.
Management: Symptomatic and supportive treatment. Restore fluid and electrolyte balance. May use ion-exchange resins to bind bile acids in the intestines.
Drug Interactions
Reduced absorption and therapeutic effect with bile acid sequestrants (e.g. colestyramine, colestipol) and aluminium-based antacids. Estrogens, oral contraceptives, and clofibrate may counteract the effect of ursodeoxycholic acid. May increase the absorption and serum levels of ciclosporin. May reduce the absorption of ciprofloxacin and nitrendipine.
Action
Description: Mechanism of Action: Ursodeoxycholic acid is a naturally occurring bile acid agent. In gallstone dissolution, it reduces the cholesterol concentration in bile and in associated gallstones by decreasing cholesterol synthesis and secretion from the liver and the fractional reabsorption of cholesterol by the intestine. Although the exact mechanism of action of ursodeoxycholic acid in primary biliary cholangitis remains uncertain, it has been shown to decrease the intrahepatic concentration of hydrophobic bile acids within hepatocytes and increase the hydrophilicity of the bile acid pool. Synonym(s): Ursodiol. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Distribution: Enters breast milk. Plasma protein binding: Approx 70%. Metabolism: Undergoes extensive enterohepatic recycling; after hepatic conjugation and biliary secretion, the drug is hydrolysed to active ursodiol, which is either recycled or converted by colonic microbial flora to form lithocholic acid. Excretion: Via urine; faeces (<1%).
Chemical Structure
Ursodeoxycholic acid Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 31401, Ursodeoxycholic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Ursodeoxycholic-Acid. Accessed Oct. 28, 2025.
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