Drug reference

Ursodeoxycholic acid

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 118, 119

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Dissolution of gallstones ▶BY MOUTH ▶Adult: 8–12 mg/kg once daily, dose to be taken at bedtime, 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 ▶BY MOUTH ▶Adult: 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 ▶BY MOUTH ▶Adult (body-weight 47 kg and above): 250 mg once daily for 10–14 days, dose to be taken at bedtime

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Contra Indications

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

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Safety

Interactions

→Appendix 1: ursodeoxycholic acid

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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

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Pregnancy

No evidence of harm but manufacturer advises avoid.

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Breast Feeding

Not known to be harmful but manufacturer advises avoid.

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Hepatic Impairment

Avoid in chronic liver disease (but used in primary biliary cirrhosis).

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Monitoring Requirements

In primary biliary cirrhosis, monitor liver function every 4 weeks for 3 months, then every 3 months.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Oral suspension CAUTIONARY AND ADVISORY LABELS 21 ▶Ursofalk (Dr. Falk Pharma UK Ltd) Ursodeoxycholic acid 50 mg per 1 ml Ursofalk 250mg/5ml oral suspension sugar-free | 250 ml P £26.98 DT = £26.98 Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Ursodeoxycholic acid (Non-proprietary) Ursodeoxycholic acid 150 mg Ursodeoxycholic acid 150mg tablets | 60 tablet P £19.02 DT = £19.02 Ursodeoxycholic acid 300 mg Ursodeoxycholic acid 300mg tablets | 60 tablet P £63.97 DT = £56.06 ▶Cholurso (HFA Healthcare Products Ltd) Ursodeoxycholic acid 250 mg Cholurso 250mg tablets | 60 tablet P £18.00 DT = £18.00 Ursodeoxycholic acid 500 mg Cholurso 500mg tablets | 60 tablet P £45.00 ▶Destolit (Norgine Pharmaceuticals Ltd) Ursodeoxycholic acid 150 mg Destolit 150mg tablets | 60 tablet P £18.39 DT = £19.02 ▶Ursofalk (Dr. Falk Pharma UK Ltd) Ursodeoxycholic acid 500 mg Ursofalk 500mg tablets | 100 tablet P £80.00 DT = £80.00 ▶Ursonorm (PRO.MED.CS Praha a.s.) Ursodeoxycholic acid 500 mg Ursonorm 500mg tablets | 60 tablet P £45.00 | 100 tablet P £49.00 DT = £80.00 Capsule CAUTIONARY AND ADVISORY LABELS 21 ▶Ursodeoxycholic acid (Non-proprietary) Ursodeoxycholic acid 250 mg Ursodeoxycholic acid 250mg capsules | 60 capsule P £29.00 DT = £12.23 | 100 capsule P £26.61 ▶Ursofalk (Dr. Falk Pharma UK Ltd) Ursodeoxycholic acid 250 mg Ursofalk 250mg capsules | 60 capsule P £30.17 DT = £12.23 | 100 capsule P £31.88 ▶Ursonorm (PRO.MED.CS Praha a.s.) Ursodeoxycholic acid 250 mg Ursonorm 250mg capsules | 60 capsule P £29.00 DT = £12.23 TERPENES

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Clinical care

Patient And Carer Advice

Patients should be given dietary advice (including avoidance of excessive cholesterol and calories).

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Dose text by age group

Adult

8–12 mg/kg once daily, dose to be taken at

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Adult

12–16 mg/kg daily in 3 divided doses for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Adult (body-weight 47 kg and above)

250 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Ursodeoxycholic acid

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 118, 119

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 118

Contra Indications

PDF page 118

Safety

Interactions

→Appendix 1: ursodeoxycholic acid

PDF page 118

Side Effects

PDF page 118

Pregnancy

No evidence of harm but manufacturer advises avoid.

PDF page 118

Breast Feeding

Not known to be harmful but manufacturer advises avoid.

PDF page 118

Hepatic Impairment

Avoid in chronic liver disease (but used in primary biliary cirrhosis).

PDF page 118

Monitoring Requirements

In primary biliary cirrhosis, monitor liver function every 4 weeks for 3 months, then every 3 months.

PDF page 118

Dose and formulations

Medicinal Forms

PDF page 119

Clinical care

Patient And Carer Advice

Patients should be given dietary advice (including avoidance of excessive cholesterol and calories).

PDF page 118

Dose text by age group

Adult

8–12 mg/kg once daily, dose to be taken at

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Adult

12–16 mg/kg daily in 3 divided doses for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Adult (body-weight 47 kg and above)

250 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 118

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.