Formulary

1.5.2 Corticosteroids

First Line
Second Line
Specialist
Hospital Only

Steroids are the most appropriate treatment for acute disease but do not prevent relapse.

The link with peptic ulceration and standard formulation of prednisolone is weak and therefore enteric coated and soluble tablets offer no additional benefit.

Systemic corticosteroids see section 6.3 Corticosteroids.

Clipper

(Beclometasone dipropionate)

  • Modified-release gastro-resistant tablets 5mg (£56.56)

Indications

  • Adjunct to aminosalicylates in acute mild to moderate ulcerative colitis

Dose

  • 5mg in the morning; maximum duration of treatment 4 weeks

Notes

  1. For initiation by a Consultant Gastroenterologist only
Budesonide
  • Budenofalk capsules containing gastro-resistant granules 3mg (£63.04 = 9mg daily)
  • Entocort CR capsules containing modified-release gastro-resistant granules 3mg (£63.04 = 9mg once daily)
  • Rectal foam enema, one metered application contains 2mg budesonide (£57.11 = 14 application canister)
  • Orodispersible tablets sugar free 1mg
  • Modified-release capsules 4mg

Indications and dose

  • Budenofalk capsules and Entocort CR capsules are included for the induction of remission in patients with mild to moderate ileocecal Crohn's disease
    • Budenofalk: 9mg (three capsules) once daily or 3mg three times daily, for up to 8 weeks; reduce dose for the last 2 weeks of treatment
    • Entocort CR: 9mg (three capsules) once daily in the morning for up to 8 weeks; reduce dose for the last 2–4 weeks of treatment
  • Budesonide rectal foam is included for active ulcerative colitis affecting the sigmoid colon and rectum
    • One metered application once daily for up to 8 weeks
  • Orodispersible tablets sugar free (hospital only) are included for induction of remission in eosinophilic oesophagitis in line with NICE TA708 (see notes 2 & 3)
  • Modified-release capsules (hospital only) are included for treating primary immunoglobulin A nephropathy (IgAN) in line with NICE TA937 (see note 4)

Notes

  1. Prescribe capsules by brand (to prevent confusion where multiple brands contain similar ingredients).
  2. Treatment with budesonide orodispersible tablets sugar free should be initiated by a physician with experience in the diagnosis and treatment of eosinophilic oesophagitis (Summary of Product Characteristics).
  3. NICE TA708: Budesonide as an orodispersible tablets sugar free is recommended as an option for inducing remission of eosinophilic oesophagitis (June 2021).
  4. NICE TA937: Targeted-release budesonide (Kinpeygo) is recommended as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more (December 2023), only if:
    1. it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated and
    2. the company provides it according to the commercial arrangement.
Prednisolone
  • Rectal solution 20mg in 100ml (£14.95 = 7 enemas)
  • Suppositories 5mg (£249.64 = 10 suppositories)

Indications

  • Ulcerative colitis
  • Crohn's disease

Dose

  • By rectum – enema: initially 20mg at bedtime for 2–4 weeks, continued if good response
  • By rectum – suppositories: 5mg inserted night and morning after a bowel movement

Notes

  1. Oral corticosteroid dosages and durations advised by consultant gastroenterologists in South Devon and Torbay NHS Foundation Trust for the management of active colitis are:
    1. Severe disease (More than six bloody stools per 24 hours, systemic symptoms e.g. pyrexia, tachycardia,) requires in-patient treatment with intravenous steroids
    2. Moderate disease (4-6 bloody stools per 24 hours) or step-down from intravenous treatment: Prednisolone 40mg daily for one week, then 30mg daily for one week, then 20mg daily for one month then review by a gastroenterologist
    3. Mild disease (less than four bloody stools per 24 hours): Prednisolone 20mg daily for four weeks and then review
Budesonide prolonged release (Cortiment)

The routine commissioning of budesonide 9mg prolonged release multi-matrix tablets used for up to 8 weeks treatment is not accepted in Devon for induction of remission in adults with mild to moderate active ulcerative colitis where 5-aminosalicylic acid (5-ASA) treatment is not sufficient (see Commissioning Policy for more details). The policy indicates that in exceptional circumstances the Trust-Managed Individual Patient Treatments process can be used for this indication.