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1.1 Chronic bowel disorders

First line drugs Second line drugs Specialist drugs Secondary care drugs

Traffic light status (TLS) explained:

  • Green: Routine prescribing within licensed indication
  • Amber 1: specialist recommendation followed by GP initiation and continuation
  • Amber 2: specialist or GP initiation in line with local guideline after 1st line failure followed by GP continuation
  • Amber 3: specialist initiation and stabilisation followed by GP continuation
  • Amber SCG: specialist initiation and stabilisation followed by GP continuation in line with an agreed shared care guideline
  • Red: Hospital or specialist prescribing only
  • Double Red: These medicines have been evaluated and rejected by MKPAG and are NOT approved for use within MK. They are not recommended for use because of lack of clinical effectiveness, cost effectiveness or safety 

 

 

 

1.1 Diverticular disease and diverticulitis 

Prescribers must seek prior approval from the Individual Funding Request (IFR) panel to use probiotics in the prevention or treatment of diverticulitis. This is due to insufficient evidence to justify the role of probiotics in this condition.

 

 

1.2 Inflammatory bowel disease 

 

Aminosalicylates

 

Mesalazine (Amber 2)

Tablets

  • Octasa® Modified release tablets 400mg, 800mg

Note:

  • Octasa is our preferred brand of mesalazine tablet; the 800mg tablets are large and relatively more expensive than the 400mg tablets; consider using 2 x 400mg when a dose of 800mg is required if appropriate.

 

 

  • Pentasa® Modified release tablets 500mg, 1g

Note: 

  • For new patients only after specialist recommendation for patients unable to take or have failed on Octasa.

 

 

  • Mezavant® XL Tablets 1.2g

 Note:

  • For those patients that Octasa is unsuitable where a once daily regimen is required for compliance purposes

 

 

Granules in sachets

  • Salofalk® gastro-resistant prolonged-release granules 500mg, 1g, 1.5g, 3g

Note: 

  • Only for patients who are unable to take tablets 

 

 

Foam enema and Enema

  • Foam enema 1g

 

 

Suppositories

  • Salofalk® suppositories 500mg, 1g

Note: 

  • Mesalazine suppositories are a useful alternative to steroid enemas in maintenance therapy.

 

  

Sulfasalazine (Amber 2)

  • Tablets e/c 500mg
  • Tablets 500mg

 

 

Corticosteroids

Position statement for Steroid Foam Enemas

  • All New Patients should be started on Budenoside enema 2mg/dose rectal foam (and not prednisolone rectal foam (previously known as predfoam))
  • Primary and Secondary Care prescribers should consider switching existing patients at the next review to Budenoside foam enema.
  • Prednisolone foam enema is not recommended as a treatment option for new patients with active Ulcerative Colitis or Crohn's Disease
  • Patients who are currently receiving prednisolone foam enemas and are stable and comfortable with their therapy should have the opportunity to continue therapy from their usual prescriber until they and their clinician consider it appropriate to stop or agree to switch to an equivalent product. 

 

 

Budesonide

  • Budenofalk® Rectal foam 2mg per actuation 

Notes:

  • £57.00 - 14 dose container with 14 applicators

 

Budesonide (Amber 2)

  • Capsules - Enteric coated granules 3mg
  • Capsules - Modified release 3mg

 

Hydrocortisone (Amber 2)

  • Foam enema 10%

Notes

  • Steroid foam enema of choice
  • £9.33 - 14 dose container with one applicator

 

Prednisolone

  • Tablets (non-enteric coated) 1mg, 5mg, 25mg
  • Retention enema 20mg
  • Suppositories 5mg

 

Prednisolone (Amber 2)

  • Rectal foam 20mg

Notes:

  • Expensive: £187.00 - 14 dose container with 14 applicators
  • Budenofalk is our cost-effective foam of choice
  • Patient shouldn't be on Predfoam longterm - usually for 6-8 weeks

 

 

Drugs affecting the immune response 

 

Azathioprine  (Amber SCG)

  • Tablets 25mg, 50mg
  • Tablets 10mg - available on named-patient basis only 

Notes:

  • Avoid concomitant use of azathioprine with allopurinol, unless supervised by an appropriate specialist.

 

 

Ciclosporin (Amber SCG in development)

  • capsules 10mg, 25mg, 50mg, 100mg
  • Oral solution 100mg/mL  

 

Mercaptopurine  (Amber SCG)

  • Tablets 50mg

 

Methotrexate  (Amber SCG)

  • Tablets 2.5mg

Notes: 

Methotrexate dose is weekly.

To avoid errors it is recommended that:

  • The patient is carefully advised of the dose and frequency and the reason for taking methotrexate and any other prescribed medicine (e.g. folic acid) 
  • The prescription and the dispensing label clearly show the dose and frequency of administration 
  • The patient is warned to report immediately the onset of any feature of blood disorders (eg. sore throat, bruising and mouth ulcers), liver toxicity (eg. nausea, vomiting, abdominal discomfort and dark urine), and respiratory effects (eg. shortness of breath) 

 

 

Monoclonal Antibodies 

 

 

Adalimumab 

  • Imraldi, Injection, 40mg/0.8mL prefilled pen or prefilled syringe
  • Amgevita, Injection, 20mg/0.4mL; 40mg/0.8mL prefilled pen or prefilled syringe
  • Humira, Injection, 40mg/0.4mL; 80mg/0.8mL prefilled pen or prefilled syringe
  • Humira, Injection, 20mg/0.2mL pre-filled syringe, 40mg/0.8mL solution in vial for first line use in paediatrics

Notes:

  • To be prescribed by brand.
  1. First line brand in adults = Imraldi®
  2. Second line brand in adults = Amgevita®
  3. Third line brand in adults = Humira®

 

  • Hulio and Hyrimoz are non-formulary within Milton Keynes Healthcare 

 

 

 

Infliximab (Specify brand when prescribing) 

  • Intravenous infusion, powder for reconstitution, 100mg vial  

Notes:

 

 

Golimumab 

  • Injection 50mg pre-filled pen or pre-filled syringe; 100mg pre-filled pen

Note:

 

 

Tofacitinib citrate

  • Xeljanz® Tablets film-coated 5mg, 10mg

Note:

 

 

 

Ustekinumab

  • Stelara® Injection, 130mg concentrate for solution for infusion in vial.

Note:

 

 

Vedolizumab 

  • Entyvio® Concentrate for intravenous infusion, powder for reconstitution, 300mg vial

Notes: 

 

 

 

 

1.3 Irritable bowel syndrome

 

Local guidance:

Management of irritable bowel syndrome with constipation (June 2019)

 

National guidance:

NICE CG61: Irritable bowel syndrome in adults - diagnosis and management (February 2015)

 

 

 

 Use of Probiotics

Prescribers must seek prior approval from the Individual Funding Request (IFR) panel to use probiotics for IBS. This is due to insufficient evidence to justify the role of probiotics in this condition. However, if the patient is self funding probiotic use, the patient should continue for at least 4 weeks while monitoring the effect.

 

Antispasmodics 

Peppermint oil 

  • Capsules 0.2mL, Gastro-resistant  

 

Guanylate cyclase-C receptor agonists 

 

Linaclotide 

  • Capsules 290 micrograms

Notes: 

Consider linaclotide for people with IBS only if:

  • optimal or maximum tolerated doses of previous laxatives from different classes have not helped and
  • they have had constipation for at least 12 months

 

 

 

 

Traffic light status (TLS) explained:

 

  • Green: Routine prescribing within licensed indication
  • Amber 1: specialist recommendation followed by GP initiation and continuation
  • Amber 2: specialist or GP initiation in line with local guideline after 1st line failure followed by GP continuation
  • Amber 3: specialist initiation and stabilisation followed by GP continuation
  • Amber SCG: specialist initiation and stabilisation followed by GP continuation in line with an agreed shared care guideline
  • Red: Hospital or specialist prescribing only
  • Double Red: These medicines have been evaluated and rejected by MKPAG and are NOT approved for use within MK. They are not recommended for use because of lack of clinical effectiveness, cost effectiveness or safety.

 

 

 

 

Return to Chapter: 1. Gastro-Intestinal System

Last updated by: Dupe Fagbenro on 27-03-2019 15:09