Generic
Ursodeoxycholic Acid
46 brands available in the market
At a glance
Ursodeoxycholic Acid is used to dissolve certain types of gallstones, to prevent them from forming, and to treat a type of liver disease called primary biliary cirrhosis. It is a bile acid which helps break down cholesterol which has formed into stones in your gallbladder.
Description
Ursodeoxycholic acid is used to reduce the cholesterol saturation of bile and to promote the dissolution of gallstones. The cholesterol saturation of bile is reduced by Ursodeoxycholic acid, allowing gradual solubilization of cholesterol gallstones.
Indications
- Cholestasis (Jaundice)
- Viral Hepatitis
- Alcoholic Fatty Liver
- Primary Biliary Cirrhosis (PBC)
- Primary Sclerosing Cholangitis (PSC)
- Dissolution of Gallstones
- Non-Alcoholic Steatohepatitis (NASH)
- Gallbladder stones
Therapeutic class
Anti-gallstones drugs: Bile Acids
Pharmacological class
Hepatoprotective
Pharmacology
Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobiliary disorders. The activity is achieved through a decrease in secretion of cholesterol in bile. It reduces cholesterol absorption, suppresses liver cholesterol synthesis, and does not inhibit bile acid synthesis.
Mechanism of action
Reduces cholesterol secretion in bile and cholesterol absorption, promoting gallstone dissolution.
Dosage
Adult Dose (Oral):
- Dissolution of cholesterol-rich gallstones: 8-12 mg/kg once daily at bedtime or in 2 divided doses; continue for 3-4 months after radiological disappearance; duration up to 2 years
- Primary biliary cirrhosis: 10-16 mg/kg daily in 2-4 divided doses
- Prophylaxis of gallstones in rapid weight loss: 300 mg twice daily
- Non-alcoholic fatty liver disease: 13-15 mg/kg/day
Administration
- Take with food
- Swallow whole; do not chew, crush or break
- Take with a glass of milk or water
Missed dose
If you miss a dose, skip it and continue with your normal schedule; do not double the dose.
Side effects
Common Side Effects:
- Abdominal pain
- Diarrhea
- Hair loss
- Itching
- Nausea
- Rash
- Vomiting
Precautions & warnings
- Does not usually affect ability to drive
- Take after a meal with a glass of milk or water
- Eat a healthy diet, exercise regularly, and avoid alcohol
- Diarrhea may occur; drink plenty of fluids and inform doctor if persistent
- Liver function and bilirubin levels may be monitored regularly
- Do not stop medication without talking to your doctor
Contraindications
- Acute inflammation of gallbladder or biliary tract
- Occlusion of biliary tract
- Frequent episodes of biliary colic
- Radio-opaque calcified gallstones
- Impaired contractility of gallbladder
- Non-functioning gallbladder
- Inflammatory bowel disease
- Active duodenal and gastric ulcer
- Acute, chronic or severe hepatic disease
Drug interactions
- Cholestyramine, charcoal, and antacids: may reduce effectiveness
- Aluminum-based antacids: may reduce absorption
- Oestrogens and clofibrate: may counteract effectiveness
- Ciclosporin: possible increase in serum concentration
- Dapsone: decreased effectiveness
- Ciprofloxacin and nitrendipine: possible decrease in serum concentration
Food interactions
May cause excessive drowsiness with alcohol.
Use in pregnancy
Use in Pregnancy: Generally considered safe; animal studies show low or no adverse effects; consult your doctor.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably safe; limited human data suggests no significant risk; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Safe for elderly
Renal / hepatic impairment
Renal Impairment: Limited information; consult your doctor
Hepatic Impairment: Limited information; consult your doctor
Overdose effects
Symptoms: Diarrhea, nausea, vomiting.
Treatment: Supportive care.
Storage conditions
Store below 25°C. Protect from light and moisture. Keep out of reach of children.