Ulcerative colitis / Inflammatory bowel disease
Suppositories, 1g daily, preferably at bedtime.
Suppositories, 1g daily, preferably at bedtime.
5mg twice daily, to be inserted in to the rectum morning and night, after a bowel movement.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear.
- Local therapies using topical treatment will resolve symptoms in most patients who have bloody diarrhoea from ulcerative proctitis, without side effects.
- Acute mild to moderate disease affecting the rectum (proctitis) is treated initially with local application of aminosalicylate. Alternatively, if this is not tolerated or not effective, a local corticosteroid can be considered.
- Some systemic absorption of steroid occurs from rectal steroids; prolonged use may lead to adrenal suppression and steroid side effects and should be avoided.
- A combination of a local and an oral aminosalicylate can be used in proctitis if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
- Maintenance rectal therapy is an appropriate treatment strategy for rectal disease. Suppositories are the treatment of choice for patients with inflammation confined to the rectum, enemas should be used for more extensive inflammation. Maintenance rectal therapy does not need to be given every day and twice weekly treatments will be sufficient for some patients.
History Notes
27/10/2022
Prescribing notes updated.
15/12/2021
East Region Formulary content agreed.
Enema, 2g once daily, dose to be administered at bedtime.
Enema, 2g once daily, dose to be administered at bedtime (alternatively 2g daily in 2 divided doses).
1 metered application once daily for up to 8 weeks.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear.
- Local therapies using topical treatment will resolve symptoms in most patients who have bloody diarrhoea from rectosigmoid disease, without side effects.
- Acute mild to moderate disease affecting the rectosigmoid is treated initially with local application of aminosalicylate. Alternatively, if this is not tolerated or not effective, a local corticosteroid can be considered.
- Some systemic absorption of steroid occurs from rectal steroids; prolonged use may lead to adrenal suppression and steroid side effects and should be avoided.
- A combination of a local and an oral aminosalicylate can be used in distal colitis if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
- Maintenance rectal therapy is an appropriate treatment strategy for rectal disease. Suppositories are the treatment of choice for patients with inflammation confined to the rectum, enemas should be used for more extensive inflammation. Maintenance rectal therapy does not need to be given every day and twice weekly treatments will be sufficient for some patients.
History Notes
27/10/2022
Addition of Salofalk foam enema in 1st line formulations and Budesonide foam enema 2nd line. Prescribing notes updated, ERWG July 22.
15/12/2021
East Region Formulary content agreed.
Oral mesalazine
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
0.5–1 g 3 times a day.
0.5–1 g 3 times a day.
2.4g once daily, increased if necessary to 4.8g once daily, review treatment at 8 weeks.
Up to 4g once daily or 4g divided into 2-4 divided doses.
Up to 4g once daily or 4g divided into 2-4 divided doses.
Up to 4g once daily or 4g divided into 2-4 divided doses.
Up to 4g once daily or 4g divided into 2-4 divided doses.
Oral AND rectal mesalazine in combination
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
2.4–4.8g once daily, alternatively 2.4–4.8g daily in divided doses, dose over 2.4g daily in divided doses only.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
1.5–3g once daily, dose preferably taken in the morning, alternatively 0.5–1g 3 times a day.
0.5–1 g 3 times a day.
0.5–1 g 3 times a day.
Suppositories, 1g daily, preferably at bedtime.
Suppositories, 1g daily, preferably at bedtime.
Enema, 2g once daily, dose to be administered at bedtime (alternatively 2g daily in 2 divided doses).
Enema, 2g once daily, dose to be administered at bedtime.
2.4g once daily, increased if necessary to 4.8g once daily, review treatment at 8 weeks.
Up to 4g once daily or 4g divided into 2-4 divided doses
Up to 4g once daily or 4g divided into 2-4 divided doses
Up to 4g once daily or 4g divided into 2-4 divided doses
Up to 4g once daily or 4g divided into 2-4 divided doses
For inducing remission in patients with mild to moderate ulcerative colitis where 5-ASA treatment is not sufficient.
30-40mg daily for 2-4 weeks, reducing by 5mg weekly thereafter according to patient response.
9mg once daily for up to 8 weeks, dose to be taken in the morning.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear.
- A combination of a local and an oral aminosalicylate can be used in disease above the rectosigmoid if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
History Notes
13/06/2024
Pentasa updates and Salofalk added. ERWG Jan 2024.
27/10/2022
Oral prednisolone added to 3rd line. Prescribing notes updated ERWG July 22.
15/12/2021
East Region Formulary content agreed.
30mg-40mg daily for 2-4 weeks, reducing by 5mg weekly thereafter according to patient response.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear.
- Severe exacerbations of ulcerative colitis require systemic corticosteroids. Patients passing 6 or more bloody stools a day with systemic disturbance should be referred to secondary care urgently.
- If there are two or more inflammatory exacerbations in a 12-month period that require treatment with oral corticosteroids, or if remission cannot be maintained by aminosalicylates, patients should be considered for second line medical therapy. Azathioprine and mercaptopurine may be used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid sparing agent. Specialist can advise on other treatment options.
History Notes
28/09/2022
Pathway renamed. Rectal prednisolone preparations removed. Prescribing notes updated, ERWG July 2022.
15/12/2021
East Region Formulary content agreed.
1.2-2.4g once daily, alternatively daily in divided doses.
1.2-2.4g once daily, alternatively daily in divided doses.
1.2-2.4g once daily, alternatively daily in divided doses.
Orally, 500mg three times a day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3g mesalazine given as a single daily dose preferably in the morning.
Orally, 500mg three times a day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3g mesalazine given as a single daily dose preferably in the morning.
Orally, 500mg three times a day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3g mesalazine given as a single daily dose preferably in the morning.
Orally, 500mg three times a day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3g mesalazine given as a single daily dose preferably in the morning.
500mg 3 times a day
2.4 g should be taken once daily.
2g once daily.
2g once daily.
2g once daily.
Prescribing Notes:
- If it is necessary to switch a patient to a different brand of mesalazine, the patient should be advised to report any change in symptom.
- Aminosalicylates can cause blood disorders; patients should report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise occurring during therapy. A blood count should be performed and the drug stopped immediately if a blood dyscrasia is suspected.
- Interstitial nephritis is a rare side effect of mesalazine. Renal function should be measured at start of treatment, at three months of treatment and then annually thereafter.
- Patients previously maintained and stable on other aminosalicylates need not be changed to a different brand.
- Patients previously being prescribed Asacol may be switched to Octasa as they are bioequivalent.
- Avoid aminosalicylates (mesalazine, olsalazine, sulfasalazine) in patients allergic to aspirin, and those with renal failure (eGFR < 20ml/minute/1.73m2).
- Mild disease extending beyond the rectum can be treated with an oral aminosalicylate alone; a combination of a local and an oral aminosalicylate can be used in proctitis or distal colitis.
- The brand should be maintained as per instructions from initiating consultant.
History Notes
13/06/2024
Pentasa, Salofalk, Mezavant XL updates. ERWG Jan 2024.
27/10/2022
Mezavant removed and prescribing notes updated, ERWG July 22.
15/12/2021
East Region Formulary content agreed.
Adalimumab should be prescribed by brand name. First choice is decided at a health board level.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
By subcutaneous injection, initially 80mg, then 40mg after 2 weeks; maintenance 40mg every 2 weeks, increased if necessary to 40mg once weekly, alternatively 80mg every 2 weeks, review treatment if no response within 12 weeks.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Infliximab should be prescribed by brand name.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Consult product literature.
Prescribing Notes:
- Biologic and targeted synthetic DMARDs are reserved for specialist use only for patients with ulcerative colitis in line with national guidance and East Region Formulary Decisions i.e. locally approved health technology assessment approvals and restrictions in line with national guidance.
- Refer to local board prescribing guidelines and MHRA guidance on Janus Kinase (JAK) Inhibitors.
- All biological medicines, including biosimilars, should be prescribed by brand name.
- Further information for patients regarding condition and treatments can be found at Crohn's & Colitis UK
- In NHS Fife, refer to IBD: use of Biological Agents and Small molecules in adult patients
History Notes
27/02/2025
Addition of ustekinumab and adalimumab formulations and etrasimod (SMC2655). Removal of ozanimod (SMC2478), tofacitinib (SMC2122) and golimumab NICE TA329 (SMC946/13), ERFC December 24.
20/11/2023
Addition of Ozanimod SMC2478 ERFC August 2023.
31/08/2023
Removed 'Remsima 120mg/1ml solution for injection pre-filled syringes' as product discontinued.
04/04/2023
Addition of Upadacitinib SMC2510, ERFC Feb23. Update to prescribing notes and pathway title, ERWG March 23.
27/10/2022
Filgotinib (Jyseleca) added, ERFC May 22.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Prescribing Notes:
- Specialist advice should be sought for acute exacerbations or if diagnosis is unclear. Children presenting with a possible flare of inflammatory bowel disease should be discussed with GI team.
- Local therapies using topical treatment will resolve symptoms in most patients who have bloody diarrhoea from ulcerative proctitis, without side effects.
- Acute mild to moderate disease affecting the rectum (proctitis) is treated initially with local application of aminosalicylate. Alternatively, if this is not tolerated or not effective, a local corticosteroid can be considered.
- Some systemic absorption of steroid occurs from rectal steroids; prolonged use may lead to adrenal suppression and steroid side effects and should be avoided.
- A combination of a local and an oral aminosalicylate can be used in proctitis if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
- Maintenance rectal therapy is an appropriate treatment strategy for rectal disease. Suppositories are the treatment of choice for patients with inflammation confined to the rectum, enemas should be used for more extensive inflammation. Maintenance rectal therapy does not need to be given every day and twice weekly treatments will be sufficient for some patients.
- For further information on the treatment of Ulcerative Colitis see NICE guideline NG130 Ulcerative Colitis management.
History Notes
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Prescribing Notes:
- Specialist advice should be sought if diagnosis is unclear. Children presenting with a possible flare of inflammatory bowel disease should be discussed with GI team.
- Local therapies using topical treatment will resolve symptoms in most patients who have bloody diarrhoea from rectosigmoid disease, without side effects.
- Acute mild to moderate disease affecting the rectosigmoid is treated initially with local application of aminosalicylate. Alternatively, if this is not tolerated or not effective, a local corticosteroid can be considered.
- Some systemic absorption of steroid occurs from rectal steroids; prolonged use may lead to adrenal suppression and steroid side effects and should be avoided.
- A combination of a local and an oral aminosalicylate can be used in distal colitis if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
- Maintenance rectal therapy is an appropriate treatment strategy for rectal disease. Suppositories are the treatment of choice for patients with inflammation confined to the rectum, enemas should be used for more extensive inflammation. Maintenance rectal therapy does not need to be given every day and twice weekly treatments will be sufficient for some patients.
History Notes
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
Oral mesalazine.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Oral AND rectal mesalazine in combination.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For inducing remission in patients with mild to moderate ulcerative colitis where 5-ASA treatment is not sufficient.
Prednisolone oral solution and soluble tablets are restricted to use in patients who are unable to swallow tablets.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
As per specialist.
Prescribing Notes:
- Specialist advice should be sought for acute exacerbations and if diagnosis is unclear. Children presenting with a possible flare of inflammatory bowel disease should be discussed with GI team.
- A combination of a local and an oral aminosalicylate can be used in disease above the rectosigmoid if topical treatment fails to adequately control symptoms.
- If the patient presents with severe disease (6 or more bloody stools a day and systemic symptoms) urgent admission should be considered and discussion with secondary care is recommended.
- Acute exacerbation of extensive disease requires systemic corticosteroids.
- Patients receiving prolonged courses of steroids should be given a steroid card.
History Notes
28/11/2024
Updating 'Prednisolone 5mg soluble tablets' to sugar free preparation - ERFC Dec 2024.
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
Prednisolone oral solution and soluble tablets are restricted to use in patients who are unable to swallow tablets.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
Prescribing Notes:
- Specialist advice should be sought for acute exacerbations and if diagnosis is unclear. Children presenting with a possible flare of inflammatory bowel disease should be discussed with GI team.
- Severe exacerbations of ulcerative colitis require systemic corticosteroids. Patients passing 6 or more bloody stools a day with systemic disturbance should be referred to secondary care urgently.
- Prednisolone oral solution and soluble tablets are restricted to use in patients who are unable to swallow tablets. These preparations are considerably more expensive than the standard tablets.
History Notes
28/11/2024
Updating 'Prednisolone 5mg soluble tablets' to sugar free preparation - ERFC Dec 2024.
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Oral azathioprine or mercaptopurine may be considered if remission is not maintained by aminosalicylates, or to maintain remission after a single episode of acute severe ulcerative colitis.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Prescribing Notes:
Aminosalicylates
- The aminosalicylate brand should be maintained as per instructions from initiating consultant.
- Different formulations of mesalazine have different release characteristics and should not be regarded as interchangeable; the proprietary name should be specified.
- If it is necessary to switch a patient to a different brand of mesalazine, the patient should be advised to report any change in symptoms.
- Aminosalicylates can cause blood disorders; patients should report any unexplained bleeding, bruising, purpura, sore throat, fever, or malaise occurring during therapy. A blood count should be performed, and the drug stopped immediately if a blood dyscrasia is suspected.
- There are case reports of interstitial nephritis and pneumonitis with mesalazine and sulfasalazine.
- Renal function should be measured at start of treatment, at three months of treatment and then annually thereafter.
- Use with caution in mild to moderate impairment (risk of toxicity including crystalluria); avoid in severe impairment.
- Avoid aminosalicylates (mesalazine, sulfasalazine) in patients allergic to aspirin.
- Disease in the left colon can be treated with an oral aminosalicylate alone, topical treatment (suppository for proctitis) and enema for disease extending beyond rectum into left colon or with a combination of both as directed by the GI specialist plus taking into account patient choice and treatment response.
- Pentasa may cause watery diarrhoea and occasionally headaches. Sulfasalazine produces more side-effects, particularly blood dyscrasias, nausea, headaches and liver dysfunction.
Azathioprine and Mercaptopurine
- Azathioprine and mercaptopurine are used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid sparing agent. These medicines are appropriate for shared care, refer to local board policies.
- For further information on the treatment of Ulcerative colitis see NICE guideline NG130 Ulcerative colitis: management.
- Bone marrow suppression is generally dose related and reversible. If the patient develops malaise, fever, bruising, bleeding, rash or a sore throat, check the white cell count and discuss with the hospital team.
- Specialist advice should be sought if patients receiving immunosuppressants come into contact with infectious diseases such as chicken pox, if immunity status is unknown.
- Severely immunosuppressed patients should not receive live vaccines. Live vaccines should be postponed until at least 6 months after stopping immunopsuppresive drugs.
- Do not crush or half azathioprine or mercaptopurine tablets.
History Notes
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.
Infliximab should be prescribed by brand name.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
Adalimumab should be prescribed by brand name. First choice is decided at a health board level.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
For dose, refer to BNF for Children.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
As per specialist.
Prescribing Notes:
- Adalimumab, infliximab, vedolizumab and tofacitinib are approved for Specialist use only in ulcerative colitis. They should only be used in patients who have not responded to conventional therapy or who are intolerant of or have contraindications to conventional therapy. Use is in line with national and local guidelines.
- The brand of adalimumab prescribed depends on health board and choice is dictated at a local level.
History Notes
06/02/2025
Addition of new amgevita formulations, ERWG Jan 24.
30/08/2023
East Region Formulary content agreed - ERFC 09/08/2023.