1.0 Gastrointestinal

Useful as adjunctive treatment in non-ulcer dyspepsia, irritable bowel syndrome and diverticular disease, to reduce intestinal motility.

Metoclopramide and domperidone stimulate gastric emptying, small intestinal transit and enhance strength of oesophageal sphincter contraction. Avoid metoclopramide in children and those under 20 years of age because of the risk of dystonic reactions.

GREEN     Domperidone - see section 4.6

GREEN     Metoclopramide- see section 4.6

Helicobacter pylori eradication regimen (see MicroGuide for further information on eradication therapy)

Total duration of therapy 7 days 

Total duration of therapy 7 days

Total duration of therapy 7 days

1.3.1 H2 receptor antagonists

All heal gastric and duodenal ulcers by reducing gastric acid output by H2 receptor blockade, and relieve peptic oesophagitis.

1.3.3 Chelates and Complexes

1.3.5 Proton pump inhibitors

Esomeprazole 

Esomeprazole should only be initiated by a consultant gastroenterologist in patients with treatment resistant severe GORD confirmed by endoscopy, who have failed to respond to the use of high doses of generic omeprazole and/or generic lansoprazole.

Esomeprazole should not be initiated by prescribers within primary care, nor should it be used in the treatment of dyspepsia or in H.pylori eradication regimes or for any other indication.

After 8 weeks therapy with esomeprazole patients should be reviewed and stepped down to a generic PPI where possible. 

AMBER    Esomeprazole capsules 20mg

First line treatment in acute diarrhoea and gastro-enteritis is prevention or treatment of fluid and electrolyte depletion. For details of oral rehydration preparations see section 9.2.1.2.  In babies and infants it is unusual for this fluid to be required for more than about two feeds.

1.4.2 Antimotility drugs

These drugs for chronic bowel disorders are recommended for initiation only on specialist advice.

1.5.1 Aminosalicylates

Mesalazine

Mesalazine is an aminosalicylate that is used routinely to induce and maintain remission in chronic inflammatory bowel disease – ulcerative colitis (UC) and Crohn’s disease.  Mesalazine is commonly given as a modified release (MR) preparation to target delivery of the drug to the diseased area of the bowel to provide topical anti-inflammatory therapy. 

Available formulations have differences in licensed indications, tablet strengths, pharmaceutical, pharmacological and pharmacokinetic properties. As the delivery characteristics of the different mesalazine preparations may vary: mesalazine preparations must be prescribed by brand name.

Octasa® is the first line choice across the ELMMB healthcare economy, and where possible 800mg strength tablets should be prescribed and supplied. Patients currently taking generic mesalazine or Asacol® can be switched to Octasa®. Switching to Octasa® in patients currently taking other brands of mesalazine can be considered, but response needs to be monitored as brands are not directly interchangeable.

AMBER     Octasa®  MR e/c 400mg & 800mg tablets (Mesalazine)  - (specify brand when prescribing)                  

In circumstances when a switch to Octasa® is not clinically appropriate, Asacol® or Mezavant® may be continued. New patients are not to be initiated on Asacol® or Mezavant®.

AMBER      Asacol® MR 400mg e/c tablets (Mesalazine) - (specify brand when prescribing)                                   

AMBER      Mezavant®  XL 1200mg tablets (once daily) (Mesalazine) - (specify brand when prescribing)              

Pentasa® is available for administration via large bore enteral feeding tubes or in swallowing difficulty. The 500mg tablet will dissolve in water, leaving small beads (0.7mm-1mm diameter) that can be swallowed or administered whole (beads must not be crushed)

AMBER     Pentasa®  e/c 500mg tablets (Mesalazine) -  (specify brand when prescribing)                                               

Rectal mesalazine preparations

Asacol® foam enemas are licensed for mild to moderate acute exacerbations of ulcerative colitis affecting the distal colon, and Asacol® suppositories are also licensed for maintenance of remission of distal ulcerative colitis.

AMBER     Asacol®  foam enema 1gram/metered application (Mesalazine)          

                  (specify brand when prescribing)

AMBER     Asacol®  suppositories 250mg, 500mg (Mesalazine)                               

                  (specify brand when prescribing)

Pentasa® liquid enemas are licensed for the treatment of ulcerative colitis affecting the distal colon and rectum

AMBER     Pentasa®  liquid retention enema 1gram/100mL (Mesalazine) - (specify brand when prescribing)              

Ipocol® is not a recommended brand of mesalazine for new patients as it is not interchangeable with Asacol® due to differences in its site of delivery, even though it is the same strength of mesalazine. 

AMBER     Balsalazide capsules 750mg

AMBER     Sulfasalazine tablets 500mg (not recommended for new patients)

1.5.2 Corticosteroids

Treatment of acute attacks of ulcerative colitis and Crohn's disease:

AMBER       Budenofalk capsules 3mg

1.5.3 Drugs affecting the immune response

Ciclosporin is occasionally used in the management of severe inflammatory bowel disease (unlicensed). It requires regular monitoring and should only be prescribed under the direction of a specialist. Azathioprine is used in the maintenance of remission of acute ulcerative colitis and Chron's disease, and also requires regular monitoring (unlicensed).

Maintenance and symptomatic treatment of ulcerative colitis and Crohn's disease:

Cytokine modulators

NICE guidance for Ulcerative Colitis updated Feb 2015 (TA329)

Infliximab ( Remicade®, Inflectra® or Remsima®), adalimumab (Humira®) and golimumab (Simponi®) are recommended as possible treatments for adults with moderate to severe ulcerative colitis if conventional therapy hasn’t worked or isn’t suitable.

Infliximab is also recommended as a possible treatment for children or young people aged 6–17 years with severe ulcerative colitis, if conventional therapy hasn’t worked or isn’t suitable.

Infliximab is a treatment option for acute exacerbation of severely active ulcerative colitis where the patient meets the NICE criteria to start a biologic (TA163). 

NICE guidance for treating moderately to severely active ulcerative colitis (TAG342) 

Vedolizumab is recommended as a possible treatment for adults with moderate to severe ulcerative colitis

NICE guidance for treating for moderately to severely active Crohn's disease after prior therapy (TA352)

NICE guidance for Crohn's disease (TAG187)   

• Adalimumab, within its licensed indications, is recommended as a treatment option for adults with severe active non-fistulising Crohn's disease as induction treatment followed by maintenance treatment. Maintenance treatment with adalimumab should continue until treatment failure (which includes the need for surgery), or until 12 months after the start of treatment, whichever is the shorter. The patient's disease should then be reassessed. Maintenance should only then be continued if there is clear evidence of ongoing disease, as determined by clinical symptoms and investigation, including endoscopy if necessary. People whose disease relapses after maintenace treatment is stopped should have the option to resume treatment for a further 12 months. They should then be reassessed to determine whether ongoing treatment is still clinically appropriate.  
• Infliximab is a treatment option for severe Crohn's disease when there is clear evidence of primary intolerance to adalimumab, or if Crohn's disease is fistulising, or if the patient is either a child or adolescent.     

Please see the full guidance for further information.

RED           Adalimumab pre-filled pen/syringe 40mg

RED           Infliximab vial for infusion 100mg

Dietary advice is important. Before prescribing laxatives it is also important to be sure the patient is constipated and that it is not secondary to an underlying undiagnosed complaint. Use only if really necessary - not for long term use.

1.6.1 Bulk-forming laxatives

May be required when fibre cannot be increased in the diet. Of value in those with small hard stools, need an adequate fluid intake and may take a few days for full effect to develop.

1.6.2 Stimulant laxatives

Increase intestinal motility, often cause abdominal cramp, should not be used in intestinal obstruction.

                    syrup 12.5mg/5mL, 50mg/5mL   

Co-danthramer and co-danthrusate are licensed for use in palliative care only

Rectal stimulant

GREEN      Glycerol suppositories 1g, 2g, 4g

1.6.3 Faecal softeners

Lubricate and soften impacted faeces and promote a bowel movement.

GREEN      Arachis oil enema

1.6.4 Osmotic laxatives

Retain fluid in the bowel and change the pattern of water distribution in the faeces. They commonly cause bloating, flatulence and cramping and are unpalatable for some patients. They must be taken regularly for up to three days before an effect is seen, making them unsuitable for rapid relief of constipation or for ‘as required’ dosing.

First Line

GREEN      Lactulose solution 3.35g/5mL                                              

Second line

1.6.5 Bowel cleansing solutions

Bowel cleansing solutions are for use only before colonic surgery, colonoscopy, or radiological examination to ensure the bowel is free of solid contents. They are not treatments for constipation.

1.6.7 5HT4 receptor agonists and guanylate cyclase-C receptor agonists

Prucalopride (Resolor®) for the treatment of chronic constipation in women (NICE TA211)

1. Prucalopride is recommended as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and in whom invasive treatment for constipation is being considered.
2. If treatment with prucalopride is not effective after 4 weeks, the woman should be re-examined and the benefit of continuing treatment reconsidered.
3. Prucalopride should only be prescribed by a clinician with experience of treating chronic constipation, who has carefully reviewed the woman’s previous courses of laxative treatments specified in point 1.

AMBER     Prucalopride  tablets f/c 1mg, 2mg                                           

Linaclotide (Constella®) treatment of moderate to severe irritable bowel syndrome with constipation in adults who have not responded to conventional treatment. Linaclotide can be considered as an option (specialist initiation only) for the treatment of persistent constipation in adults with IBS who have not responded to conventional treatment based on suggested treatment pathway:

1. Follow irritable bowel syndrome in adults NICE CG61 (2008) and manage constipation with a range of osmotic and stimulant laxatives with the long-term use of soluble fibre

2. Where antispasmodics and laxatives are ineffective for pain relief, NICE suggests the use of tricyclic antidepressants (unlicensed use)

3. Assess patient at 4 weeks (in secondary care) and if no improvement discontinue use

4. If continued beyond 4 weeks, re-assess at 6 months for contniued benefit

AMBER     Linaclotide capsules 290 micrograms

Lubiprostone (Amitiza®) is recommended as an option for treating chronic idiopathic constipation, that is, for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered. 

If treatment with lubiprostone is not effective after 2 weeks, the person should be re-examined and the benefit of continuing treatment reconsidered.  Treatment should only be prescribed by a clinician with experience of treating chronic idiopathic constipation. As per NICE TAG 318 guidance.

AMBER            Lubiprostone  (Amitiza®) capsules 24mcg

Naloxegol (Moventig®) is recommended, within its marketing authorisation, as an option for treating opioid induced constipation in adults whose constipation has not adequately responded to laxatives

• An inadequate response is defined as opioid‑induced constipation symptoms of at least moderate severity in at least 1 of the 4 stool symptom domains (that is, incomplete bowel movement, hard stools, straining or false alarms) while taking at least 1 laxative class for at least 4 days during the prior 2 weeks. NICE TAG345.

1.7.1 Soothing haemorrhoidal preparations

GREEN       Anusol® cream & suppositories

1.7.2 Compound haemorrhoidal preparations with corticosteroids    

GREEN       Anusol® HC ointment (do not use for longer than 7 days)            

1.7.3 Rectal sclerosants

RED           Oily phenol injection 5%

1.7.4. Management of anal fissures

The management of anal fissure requires stool softening by increasing dietary fibre or by the use of a bulk-forming laxative. Short term use of local anaesthetic preparations may help. If these measures are inadequate the patient should be referred for specialist treatment in hospital – here the local use of glyceryl trinitrate or diltiazem may be appropriate.

AMBER     Diltiazem (Anoheal®) cream 2%

AMBER     Glyceryl trinitrate (Rectogesic®) ointment 0.4%