Formulary
Ursodeoxycholic acid: Indications, Dosing, Side Effects and Interactions
Ursodeoxycholic acid clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Ursodeoxycholic acid: Indications, Dosing, Side Effects and Interactions
Ursodeoxycholic acid clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Dissolution of gallstones**
- **Adult** (By Mouth): 8-12 mg/kg once daily for up to 2 years, dose to be taken at bedtime, treatment is continued for 3-4 months after stones dissolve, alternatively 8-12 mg/kg daily in 2 divided doses for up to 2 years, treatment is continued for 3-4 months after stones dissolve.
**Primary biliary cirrhosis**
- **Adult** (By Mouth): 12-16 mg/kg daily in 3 divided doses for 3 months, then 12-16 mg/kg once daily, dose to be taken at bedtime.
**Gall reflux gastritis**
- **Adult** (By Mouth): (body-weight 47 kg and above) 250 mg once daily for 10-14 days, dose to be taken at bedtime.
**Cholestasis for ursodeoxycholic acid**
- **Neonate** (By mouth): 5 mg/kg 3 times a day, increased if necessary up to 10 mg/kg 3 times a day, dose to be adjusted according to response.
- **Child 1-23 months** (By mouth): 5 mg/kg 3 times a day, increased if necessary up to 10 mg/kg 3 times a day, dose to be adjusted according to response.
**Improvement of hepatic metabolism of essential fatty acids and bile flow, in children with cystic fibrosis for ursodeoxycholic acid**
- **Child** (By mouth): 20-30 mg/kg daily in 2-3 divided doses.
**Cholestasis associated with total parenteral nutrition for ursodeoxycholic acid**
- **Neonate** (By mouth): 10 mg/kg 3 times a day.
- **Child** (By mouth): 10 mg/kg 3 times a day.
**Sclerosing cholangitis for ursodeoxycholic acid**
- **Child** (By mouth): 5-10 mg/kg 2-3 times a day, increased if necessary up to 15 mg/kg 3 times a day, dose to be adjusted according to response.
Contraindications
Acute inflammation of the gall bladder; frequent episodes of biliary colic; inflammatory diseases and other conditions of the colon, liver or small intestine which interfere with enterohepatic circulation of bile salts; non-functioning gall bladder; radio-opaque stones
Side effects
Common or very common Diarrhoea; pale faeces Rare or very rare Abdominal pain upper; cholelithiasis calcification; hepatic cirrhosis exacerbated; skin reactions Frequency not known Nausea; vomiting
Interactions
**Other interactions (9):**
- Ursodeoxycholic acid should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations...
- Ursodeoxycholic acid can affect the absorption of ciclosporin from the intestine.
- In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
- In isolated cases, ursodeoxycholic acid can reduce the absorption of ciprofloxacin.
- In a clinical study in healthy volunteers, concomitant use of ursodeoxycholic acid (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin.
- The clinical relevance of this interaction also with regard to other statins is unknown.
Pregnancy
Avoid unless essential (toxicity in animal studies). M
Breast feeding
Not known to be harmful but manufacturer advises avoid.
Hepatic impairment
Avoid in chronic liver disease (but used in primary biliary cirrhosis).
Medicinal forms
Solution,Tablet,Capsule,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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