Drug reference

Budesonide

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 70, 71, 72

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

Overview

Drug Action

Budesonide is a glucocorticoid, which exerts signiﬁcant local anti-inﬂammatory effects.

PDF page 70

Indications And Dose

BUDENOFALK ® CAPSULES Mild to moderate Crohn’s disease affecting the ileum or ascending colon ▶BY MOUTH ▶Adult: 9 mg once daily for 8 weeks, to be taken in the morning, alternatively 3 mg 3 times a day for 8 weeks, reduce dose gradually over two weeks following treatment Collagenous colitis ▶BY MOUTH ▶Adult: 9 mg once daily for 8 weeks, to be taken in the morning, reduce dose gradually over two weeks following treatment Autoimmune hepatitis, induction of remission ▶BY MOUTH ▶Adult: 3 mg 3 times a day Autoimmune hepatitis, maintenance ▶BY MOUTH ▶Adult: 3 mg twice daily BUDENOFALK ® GRANULES Mild to moderate Crohn’s disease affecting the ileum or ascending colon | Collagenous colitis ▶BY MOUTH ▶Adult: 9 mg once daily for 8 weeks, to be taken in the morning about 30 minutes before breakfast, reduce dose gradually over two weeks following treatment BUDENOFALK ® RECTAL FOAM Ulcerative colitis affecting sigmoid colon and rectum ▶BY RECTUM ▶Adult: 1 metered application once daily for up to 8 weeks DOSE EQUIVALENCE AND CONVERSION ▶For Budenofalk ® rectal foam:1 metered application is equivalent to budesonide 2 mg. CORTIMENT ® Induction of remission of mild-to-moderate active ulcerative colitis ▶BY MOUTH ▶Adult: 9 mg once daily for up to 8 weeks, dose to be taken in the morning ENTOCORT ® CAPSULES Active microscopic colitis ▶BY MOUTH ▶Adult: 9 mg once daily, to be taken in the morning Mild to moderate Crohn’s disease affecting the ileum or ascending colon ▶BY MOUTH ▶Adult: 9 mg once daily for up to 8 weeks; reduce dose for the last 2–4 weeks of treatment, to be taken in the morning ENTOCORT ® ENEMA Ulcerative colitis involving rectal and recto-sigmoid disease ▶BY RECTUM ▶Adult: 1 enema daily for 4 weeks, to be administered at bedtime JORVEZA ® Eosinophilic oesophagitis (initiated by a specialist) ▶BY MOUTH ▶Adult: 1 mg twice daily for 6 weeks; treatment may be extended to up to 12 weeks if required, to be taken after food

PDF pages 70, 71

Cautions

Autoimmune hepatitis

PDF page 71

Prescribing And Dispensing Information

▶With oral use Flavours of granule formulations may include lemon. ENTOCORT ® CAPSULES ▶With oral use Dispense modiﬁed-release capsules in original container (contains desiccant).

PDF page 71

National Funding Access Decisions

CORTIMENT ® Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (October 2016) that budesonide (Cortiment ®) is accepted for restricted use within NHS Scotland for induction of remission of mild-to- moderate active ulcerative colitis where aminosalicylate treatment is not sufﬁcient, and only if patients present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide. BUDENOFALK ® CAPSULES Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (May 2015) that Budenofalk ® gastro-resistant capsules are accepted for restricted use within NHS Scotland for the treatment of autoimmune hepatitis in non-cirrhotic patients who are intolerant of conventional oral corticosteroids (prednisolone) with severe corticosteroid-related side effects (actual or anticipated) such as psychosis, poorly controlled diabetes or osteoporosis.

PDF page 71

Safety

Interactions

→Appendix 1: corticosteroids

PDF page 71

Side Effects

▶Common or very common ▶With oral use Muscle twitching. oedema. oral disorders ▶With rectal use Diarrhoea. gastrointestinal disorders

PDF page 71

Hepatic Impairment

For Budenofalk ® manufacturer advises avoid in cirrhosis (risk of increased exposure, limited information available). JORVEZA ® Manufacturer advises avoid (no information available).

PDF page 71

Renal Impairment

JORVEZA ® Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).

PDF page 71

Monitoring Requirements

Manufacturer advises when used in autoimmune hepatitis, liver function tests should be monitored every 2 weeks for 1 month, then at least every 3 months.

PDF page 71

Dose and formulations

Directions For Administration

▶With oral use Granules should be placed on tongue and washed down with water without chewing. JORVEZA ® Manufacturer advises the tablet should be placed on the tip of the tongue, gently pressed against the roof of the mouth to dissolve, and the dissolved material swallowed with saliva as the tablet disintegrates. Patients should avoid eating, drinking or performing oral hygiene for at least 30 minutes after taking the tablet. Oral solutions, sprays or chewable tablets should be avoided for at least 30 minutes before and after taking the tablet.

PDF page 71

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Modified-release tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Cortiment (Ferring Pharmaceuticals Ltd) Budesonide 9 mg Cortiment 9mg modified-release tablets | 30 tablet P £75.00 DT = £75.00 Gastro-resistant capsule CAUTIONARY AND ADVISORY LABELS 5, 10, 22, 25 ▶Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 3 mg Budenofalk 3mg gastro-resistant capsules | 100 capsule P £75.05 DT = £75.05 Foam EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and stearyl alcohol), disodium edetate, propylene glycol, sorbic acid ▶Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 2 mg per 1 actuation Budenofalk 2mg foam enema | 14 dose P £57.11 DT = £57.11 Modified-release capsule CAUTIONARY AND ADVISORY LABELS 5, 10, 25 ▶Entocort CR (Tillotts Pharma Ltd) Budesonide 3 mg Entocort CR 3mg capsules | 50 capsule P £37.53 | 100 capsule P £75.05 DT = £75.05 Gastro-resistant granules CAUTIONARY AND ADVISORY LABELS 5, 10, 22, 25 ▶Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 9 mg Budenofalk 9mg gastro-resistant granules sachets | 60 sachet P £135.00 DT = £135.00 Orodispersible tablet CAUTIONARY AND ADVISORY LABELS 10 ELECTROLYTES: May contain Sodium ▶Jorveza (Dr. Falk Pharma UK Ltd) Budesonide 1 mg Jorveza 1mg orodispersible tablets sugar-free | 90 tablet P £323.00 DT = £323.00 Enema ▶Entocort (Tillotts Pharma Ltd) Budesonide 20 microgram per 1 ml Entocort 2mg/100ml enema | 7 enema P £33.66 DT = £33.66 IMMUNOSUPPRESSANTS › MONOCLONAL ANTIBODIES, ANTI-LYMPHOCYTE Gastro-intestinal system

PDF pages 71, 72

Clinical care

Patient And Carer Advice

▶With oral use Patients or carers should be given advice on how to administer budesonide granules. JORVEZA ® Manufacturer advises patients or carers should be given advice on how to administer orodispersible tablets. Gastro-intestinal system

PDF page 71

Dose text by age group

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

3 mg 3 times a day

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

PDF page 70

Adult

3 mg twice daily

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

PDF page 70

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

1 metered application once daily for up to

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

PDF page 70

Adult

9 mg once daily for up to 8 weeks, dose to be

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

PDF page 71

Adult

9 mg once daily, to be taken in the morning

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

PDF page 71

Adult

9 mg once daily for up to 8 weeks; reduce dose

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

PDF page 71

Adult

1 enema daily for 4 weeks, to be administered at

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

PDF page 71

Adult

1 mg twice daily for 6 weeks; treatment may be

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

PDF page 71

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

Drug reference

Budesonide

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 70, 71, 72

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

Overview

Drug Action

Budesonide is a glucocorticoid, which exerts signiﬁcant local anti-inﬂammatory effects.

PDF page 70

Indications And Dose

PDF pages 70, 71

Cautions

Autoimmune hepatitis

PDF page 71

Prescribing And Dispensing Information

▶With oral use Flavours of granule formulations may include lemon. ENTOCORT ® CAPSULES ▶With oral use Dispense modiﬁed-release capsules in original container (contains desiccant).

PDF page 71

National Funding Access Decisions

PDF page 71

Safety

Interactions

→Appendix 1: corticosteroids

PDF page 71

Side Effects

▶Common or very common ▶With oral use Muscle twitching. oedema. oral disorders ▶With rectal use Diarrhoea. gastrointestinal disorders

PDF page 71

Hepatic Impairment

For Budenofalk ® manufacturer advises avoid in cirrhosis (risk of increased exposure, limited information available). JORVEZA ® Manufacturer advises avoid (no information available).

PDF page 71

Renal Impairment

JORVEZA ® Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).

PDF page 71

Monitoring Requirements

Manufacturer advises when used in autoimmune hepatitis, liver function tests should be monitored every 2 weeks for 1 month, then at least every 3 months.

PDF page 71

Dose and formulations

Directions For Administration

PDF page 71

Medicinal Forms

PDF pages 71, 72

Clinical care

Patient And Carer Advice

PDF page 71

Dose text by age group

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

3 mg 3 times a day

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

PDF page 70

Adult

3 mg twice daily

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

PDF page 70

Adult

9 mg once daily for 8 weeks, to be taken in the

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

PDF page 70

Adult

1 metered application once daily for up to

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

PDF page 70

Adult

9 mg once daily for up to 8 weeks, dose to be

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

PDF page 71

Adult

9 mg once daily, to be taken in the morning

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

PDF page 71

Adult

9 mg once daily for up to 8 weeks; reduce dose

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

PDF page 71

Adult

1 enema daily for 4 weeks, to be administered at

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

PDF page 71

Adult

1 mg twice daily for 6 weeks; treatment may be

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

PDF page 71

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