Download Gastro-intestinal System - Eastbourne, Hailsham and Seaford CCG

CHAPTER 1
Second line drugs –
alternatives (often in
specific conditions) in
both primary and
secondary care
First line drugs
– drugs
recommended in
both primary and
secondary care
GASTRO-INTESTINAL SYSTEM
Specialist drugs –
where a specialist
input is needed
(see introduction
for definition)
Specialist only drugs – prescribing within
specialist service only
Page
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
Date
08/10
04/11
05/12
01/13
03/13
06/14
10/14
11/14
12/14
02/15
03/15
07/15
09/15
10/15
11/15
08/16
09/16
04/17
Dyspepsia and gastro-oesophageal reflux
disease
Antispasmodics and other drugs altering
gut motility
Ulcer healing drugs
Dyspepsia Management Guidelines ~
Summary
Acute diarrhoea
Chronic bowel disorders
Laxatives
Local preparations for anal and rectal
disorders
Stoma care
Drugs affecting intestinal secretions
Additional NICE Guidance
Revision
1.5 (NICE guidance), 1.6 (NICE guidance)
1.6 (NICE guidance), minor amendment
1.9.2 (drug addition), 1.5.2 (drug deletion)
1.3.5 (Updated MHRA Drug Safety)
1.5.3 (NICE guidance)
1.2, 1.5 (MHRA drug safety update)
1.6 (NICE guidance)
1.3 (NICE guidance) 1.6( Reformatting)
1.6 (Drug addition)
1.6 (NICE guidance)
1.5 (NICE guidance)
1.5 (NICE guidance), (drug amendment) 1.9 (minor
amendment)
1.5 (NICE guidance)
1.6 (NICE guidance)
1.5 (NICE guidance)
NICE Guidance
NICE Guidance
1.5 (Minor amendment)
First line drugs
Second line drugs
Specialist drugs
2
2
3
3
7
7
9
13
12
12
14
Contributor
G Ells
G Ells
G Ells
A Luck
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
G Ells
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 1 of 14
1.1 Dyspepsia and gastro-oesophageal reflux disease
1.1.1 Antacids and simeticone
 Mixture
Asilone
 MixtureSF
Magnesium
 (Contains about 6mmol of sodium in
trisilicate
Co-magaldrox
(Mucogel®)


10ml, laxative)
SuspensionSF 195/220
(Low sodium, bowel neutral)
1.1.2 Compound alginates and proprietary indigestion preparations
 Tablets (Contains about 1mmol sodium
Gastrocote
per tablet)
Infant Gaviscon®

Peptac®

Infacol®

Oral powderSF (Contains 0.92mmol of
sodium per dose)
SuspensionSF (Contains 6.2mmol of
sodium in 10ml)
LiquidSF
Notes:
1. Alginate containing products have low acid suppressant activity and should be reserved for patients
with reflux symptoms.
2. Peptac® contains sodium alginate 250mg, sodium bicarbonate 133.5mg and calcium carbonate
80mg in 5ml. Peptac® has been included as the first choice alginate.
3. Infacol® contains activated dimeticone and may be useful in gripes, colic or wind pains.
1.2 Antispasmodics and other drugs altering gut motility
Antispasmodics
N.B. modified release tablets are excluded
 Tablets 135mg
Mebeverine
from formulary see below
Peppermint oil


Liquid 50mg in 5ml
Capsules, enteric coated 0.2ml
Alverine citrate

Capsules 60mg, 120mg
Hyoscine
butylbromide


Injection 20mg in 1ml
Tablets 10mg
1.
2.
Not modified release
Mebeverine is included as a first line treatment, but it should be remembered that diet alone
should be tried before any drug therapy. Dose is given 20 minutes before food, therefore no
justification for twice daily MR tablets. Liquid preparation in swallowing difficulties only.
Hyoscine butylbromide may be useful in gastro-intestinal disorders characterised by smooth
muscle spasm and in terminal care, but its anticholinergic side effects limit its use.
Drugs Altering Gut Motility (also appear in CNS chapter)
Metoclopramide
Domperidone

Tablets 10mg

Tablets 10mg
MHRA drug safety update May 2014
Due to cardiac side effects, domperidone is now restricted to use in the relief of nausea and vomiting and
should be used at the lowest effective dose for the shortest possible time.
Domperidone is now contraindicated in people:
o with conditions where cardiac conduction is, or could be, impaired
o with underlying cardiac diseases such as congestive heart failure
o receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors
o with severe hepatic impairment
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 2 of 14
1.3 Ulcer healing drugs
Things To Consider About Acid Suppression
1. Take a good history. “Indigestion” does not necessarily mean give acid suppression.
2. Lifestyle changes should be pursued. Patients should be advised to:
 Avoid large meals shortly before retiring to bed
 Reduce the amount of fat in their diet
 Raise the head of the bed at night
3. In the event that NSAIDs are required rather than simple analgesics, use the less GI toxic agent
(ibuprofen, naproxen). All NSAIDs, including coxibs, have the propensity to cause serious GI
events so should only be used after careful consideration. In those at risk, a PPI, ranitidine or
misoprostol may be considered for protection against NSAID associated gastric and duodenal
ulcers.
Dyspepsia Management Guidelines ~ Summary
NICE CG184: Dyspepsia and gastro‑ oesophageal reflux disease: Investigation and
management of dyspepsia, symptoms suggestive of gastro‑ oesophageal reflux disease, or
both
A. Patients with dyspepsia in whom diagnostic endoscopy is appropriate.
1. Review medications for possible causes of dyspepsia (eg. theophyllines, bisphosphonates,
corticosteroids & NSAIDs). In patients requiring referral, suspend NSAID use.
3. Pre treatment with anti-secretory drugs may mask significant diagnoses at endoscopy. For patients
having their first endoscopy, it is advised that they stop their treatment 2 weeks before.
B. Interventions for uninvestigated dyspepsia
1. Initial theraputic strategies for dyspepsia are empirical treatment with a PPI or testing for and
treating H. pylori. A 2-week washout period following PPI use is necessary before testing for H.
pylori with a breath test, therefore it is preferable to test for H Pylori first and treat if necessary
(result is available within 24 to 48 hours) to avoid a patient starting a PPI and then having to stop
prior to a test.
2. Offer empirical full-dose PPI therapy for 4 weeks to people with dyspepsia.
3. If there is an inadequate response to a PPI, offer H2 receptor antagonist (H2RA) therapy instead.
C. Interventions for gastro-oesophageal reflux disease (GORD)
1. Offer patients who have GORD a full dose PPI for 4-8 weeks.
2. If symptoms recur following initial treatment, offer a PPI at the lowest dose possible to control
symptoms, with a limited number of repeat prescriptions.
3. Discuss with people how they can manage their own symptoms by using the treatment when they
need it.
4. If there is an inadequate response to a PPI offer H2RA therapy instead.
5. Offer people a full-dose PPI for 8 weeks to heal severe oesophagitis, taking into account the
person's preference and clinical circumstances (for example, underlying health conditions and
possible interactions with other drugs).
6. If initial treatment for healing severe oesophagitis fails, consider a high dose of the initial PPI,
switching to another full-dose PPI or switching to another high-dose PPI.
7. Offer a full-dose PPI long-term as maintenance treatment for people with severe oesophagitis,
taking into account the person's preference and clinical circumstances (for example, tolerability of
the PPI, underlying health conditions and possible interactions with other drugs), and the
acquisition cost of the PPI.
8. If the person's severe oesophagitis fails to respond to maintenance treatment, carry out a clinical
review. Consider switching to another PPI at full dose or high dose and/or seeking specialist
advice.
D. Interventions for peptic ulcer disease
1. Offer H. pylori eradication therapy to H. pylori positive patients who have peptic ulcer disease.
2. For patients using NSAIDs with diagnosed peptic ulcer, stop the use of NSAIDs where possible.
Offer full-dose PPI for 2 months to these patients and if H. pylori is present, subsequently offer
eradication therapy.
3. Offer people with gastric ulcer and H pylori repeat endoscopy 6 to 8 weeks after beginning
treatment, depending on the size of the lesion.
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 3 of 14
4. Offer people with peptic ulcer (gastric or duodenal) and H pylori retesting for H pylori 6 to 8 weeks
after beginning treatment, depending on the size of the lesion.
5. If symptoms recur after initial treatment, offer a PPI to be taken at the lowest dose possible to
control symptoms. Discuss using the treatment on an 'as needed' basis with people to manage
their own symptoms.
E. Interventions for functional dyspepsia
1. Management of endoscopically determined non-ulcer dyspepsia involves initial treatment for H.
pylori if present, followed by symptomatic management and periodic monitoring.
2. Re-testing after eradication should not be offered routinely, although the information it provides
may be valued by individual patients.
3. If H. pylori has been excluded and symptoms persist, offer either a low-dose PPI or an H2RA for 4
weeks.
4. If symptoms continue or recur after initial treatment, offer a PPI or H2RA to be taken at the lowest
dose possible to control symptoms.
5. Discuss using PPI treatment on an 'as-needed' basis with people to manage their own symptoms.
F. Reviewing patient care
1. Offer patients requiring long-term management of symptoms for dyspepsia an annual review of
their condition, encouraging them to try stepping down or stopping treatment (unless there is an
underlying condition or co-medication that needs continuing treatment).
2. A return to self-treatment with antacid and/or alginate therapy (either prescribed or purchased
over- the-counter and taken as required) may be appropriate.
G. H. pylori testing and eradication
Pylobactell®
1. H. pylori can be initially detected using carbon urea breath test or laboratory-based serology where
its performance has been locally validated. The C urea breath test has a high sensitivity and
specificity (>98%) and is non-invasive and is therefore the investigation of choice in primary care.
2. Surgery/office-based serological tests for H. pylori cannot be recommended because of their
inadequate performance. In secondary care a stool antigen test may be used.
3. For patients who test positive provide eradication therapy as below taking into consideration:
a. Antibiotic allergies
b. Previous exposure to clarithromycin and metronidazole
c. Acquisition cost
Suggested regime for the eradication of Helicobacter pylori
PPI
Lansoprazole caps 30mg bd or
Omeprazole caps 20mg bd
+ amoxicillin
1g BD
+ Clarithromycin
OR
metronidazole
500mg BD
all for 7 days
400mg bd
OR
For penicillin allergic patients
PPI
Lansoprazole caps 30mg bd or
Omeprazole caps 20mg bd
+ clarithromycin
500mg BD
+ metronidazole
400mg BD
all for 7 days
OR
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 4 of 14
For penicillin allergic patients with previous exposure to clarithromycin
PPI
Lansoprazole caps 30mg bd or
Omeprazole caps 20mg bd
+ bismuth
240mg BD
+metronidazole
400mg BD
+ tetracycline
1g BD
all for 7 days
Second-line treatment
1. Offer people who still have symptoms after first-line eradication treatment a 7-day, twice-daily course of
treatment with PPI, amoxicillin and the alternative antibiotic they did not receive as first line treatment.
2. Offer people who have had previous exposure to clarithromycin and metronidazole a 7-day, twice-daily
course of treatment with a PPI, amoxicillin and a quinolone or tetracycline (whichever has the lowest
acquisition cost).
3. Offer people who are allergic to penicillin (and who have not had previous exposure to a quinolone) a 7day, twice-daily course of treatment with a PPI, metronidazole and levofloxacin.
4. Offer people who are allergic to penicillin and who have had previous exposure to a quinolone a PPI,
bismuth, metronidazole and tetracycline.
5. Seek advice from a gastroenterologist if eradication of H pylori is not successful with second-line
treatment.
1.3.1 H2-receptor antagonists
Ranitidine
Cimetidine






Tablets 150mg, 300mg
Effervescent tablets 150mg
Injection 50mg in 2ml
Oral solution 75mg in 5ml
Tablets 200mg, 400mg, 800mg
Oral solution 200mg in 5ml
Start dose 150mg bd. If symptoms not
controlled with 300mg bd use PPI.
Cimetidine is recommended second-line due to its interactions with anticoagulants, anti-epileptics,
ciclosporin, theophylline and anti-arrhythmics.
Effervescent tablets and liquid formulations should only be used in children where dosing requires it
and in adults with swallowing difficulties
1.3.3 Chelates and complexes
Sucralfate


Tripotassium Dicitratobismuthate
De-noltab®

Tablets 1g
Oral Suspension 1g in 5ml
Tablets 120mg
Sucralfate®: Following reports of bezoar formation associated with sucralfate, the CSM has advised
caution in seriously ill patients, especially those receiving concomitant enteral feeds or those with
predisposing conditions such as delayed gastric emptying. De-Noltab® requires counselling on correct
administration. Can blacken faeces and darken tongue.
De-Noltab® is only to be used as part of quadruple eradication therapy.
1.3.4 Prostaglandin analogues
Misoprostol

Tablets 200 micrograms
Misoprostol is included as one option for NSAID prophylaxis. However, NSAIDs should be avoided in
patients with dyspepsia wherever possible and a PPI is the preferred agent for gastroprotection. Refer
also to NSAID section in BNF chapter 10. Effective contraception must be used in women of
childbearing age. Contraindicated in pregnancy.
The dose of misoprostol required to treat benign gastric and duodenal ulceration or NSAID-associated
ulceration is 800micrograms per day in divided doses. However, colic and diarrhoea may limit the dose.
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 5 of 14
1.3.5 Proton Pump Inhibitors (PPIs)
CAUTION: Proton Pump Inhibitors may relieve or mask the symptoms from a malignant gastric ulcer and
may even induce the healing of a lesion and therefore delay diagnosis.
Where a PPI is indicated the LOWEST EFFECTIVE DOSE should be prescribed.
Indication
Omeprazole (O) / Lansoprazole (L) (capsules)
Treatment of Gastro-oesophageal
reflux disease
O: 20mg daily for 4-8 weeks,
L: 30mg daily for 4-8 weeks,
If symptoms recur step down to lowest dose needed to control
symptoms. Discuss use on an as-needed basis
O: 40mg daily for 8 weeks,
L: 30mg daily for 8 weeks,
Long term maintenance as above
Failure of treatment:
Treatment of Gastro-oesophageal
reflux disease - severe
oesophagitis
Try a different PPI as above or:
O: 40mg twice a day,
L: 30mg twice a day
Maintenance:
O: 40mg daily
L: 30mg daily
O: 20mg daily for 4 weeks
L: 30mg daily for 4 weeks
If symptoms recur step down to lowest dose needed to control
symptoms. Discuss use on an as-needed basis
O: 20mg daily for 4 weeks
Maintenance of recurrent ulcers 20mg daily
L: 30mg daily for 4 weeks; maintenance 15mg daily
O: 20mg daily for 8 weeks
L: 30mg daily for 8 weeks
Zollinger-Ellison Syndrome
O: 20-120mg daily
L: 60 – 120mg daily
O: 20mg daily for 4 weeks, continue for further 4 weeks if not fully
healed.
L: 30mg daily for 4 weeks, continued for further 4 weeks if not fully
healed. Prophylaxis 15-30mg daily.
O: 20mg daily
L: 15-30mg daily
Uninvestigated dyspepsia
Duodenal Ulcer
Gastric Ulcer
NSAID associated ulcers
NSAID Protection
PPIs are not indicated for use in:
 Non-specific abdominal symptoms such as bloating or flatulence
 Right or left quadrant abdominal discomfort / pain
 Lower abdominal discomfort / pain
MHRA Drug Safety Update – Interaction between the use of clopidogrel and PPI’s – April 2010
In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton
pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be
discouraged. The current evidence does not support extending this advice to other PPIs.
Lansoprazole
Omeprazole
Pantoprazole
First line drugs






Capsules 15mg, 30mg
Orodispersible tablets 15mg, 30mg
Capsules 20mg, 40mg
Dispersible tablets 10mg, 20mg
Injection 40mg
Tablets 20mg, 40mg
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 6 of 14
Omeprazole injection indicated in acute GI bleed (confirmed by endoscopy or frank haematemesis, life
threatening GI bleed, bleeding varices). NBM is not an indication for use of the injection.
Orodispersible and dispersible tablets should only be used in children where dosing requires it and in adults
with swallowing difficulties
1.4 Acute diarrhoea
1.4.2 Antimotility drugs
 Capsules 2mg
Loperamide
Codeine phosphate


Oral syrup in swallowing difficulties only
SyrupSF
Oral
1mg / 5ml
Tablets 15mg, 30mg, 60mg
Notes:
1. A diagnosis of the cause of diarrhoea should be made before starting symptomatic treatment and acute
prescriptions should be restricted to 12 loperamide capsules or 20 codeine tablets.
2. Diarrhoea should normally be managed with electrolyte replacement only. Anti-motility drugs should be
restricted to short term use only.
3. The maximum dosage for loperamide is 16mg daily (8 capsules).
4.
Codeine has addictive properties and should be reserved for short courses unless specialist
involvement.
1.5 Chronic bowel disorders
Treatment of ulcerative colitis and Crohn’s disease
Subcutaneous injection
 Humira® 40mg pre-filled syringe
Adalimumab
Golimumab
Infliximab
Vedolizumab▼






40mg pre-filled pen
40mg vial
Simponi® 50mg, 100mg pre-filled
pen
Inflectra®▼ 100mg vial
Remicade® 100mg vial
Remsima▼ 100mg vial

Entyvio® 300mg vial
Subcutaneous injection
Biosimilar - 1st choice
Prescribe by brand
Biosimilar - 1st choice
IV infusion
Two biosimilar versions of infliximab are now available. They originate from the same manufacturer
hence either can be used when a biosimilar version of infliximab has been prescribed.
NICE Guidance TA 187: Crohn’s disease – Infliximab (review) and adalimumab (review of TA
40) May 2010
Infliximab and adalimumab are recommended as treatment options for adults

with severe active Crohn’s disease (Crohn’s Disease Activity Index score of 300 or more and a
Harvey-Bradshaw Index of 8/9 or above).
and
 whose disease has not responded to conventional therapy (including immunosuppressive and/or
corticosteroid treatments), or who are intolerant of or have contraindications to conventional
therapy.
Infliximab is also recommended as a treatment option in the flowing circumstances:
 For active fistulating Crohn’s disease where the condition has not responded to conventional
treatments or where patients are intolerant of or have contraindications to conventional
treatments.
 In patients aged 6-17 years with severe active Crohn’s disease whose disease has not
responded to conventional therapy or where there is intolerance or contraindications to
conventional therapy.
Infliximab or adalimumab should be given as a planned course of treatment until treatment failure
(including the need for surgery), or until 12 months after the start of treatment, whichever is shorter.
A gastroenterologist experienced in the management of Crohn’s disease should prescribe and
monitor these treatments.
NICE Guidance TA 329: Infliximab, adalimumab and golimumab for treating moderately to
severely active ulcerative colitis (including a review of TA140 and TA262) Feb 2015
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 7 of 14
Infliximab, adalimumab and golimumab are recommended, within their marketing authorisations, as
options for treating moderately to severely active ulcerative colitis in adults whose disease has
responded inadequately to conventional therapy including corticosteroids and mercaptopurine or
azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.
Infliximab is recommended, within its marketing authorisation, as an option for treating severely
active ulcerative colitis in children and young people aged 6–17 years whose disease has responded
inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or
who cannot tolerate, or have medical contraindications for, such therapies.
They should be given as a planned course of treatment until treatment fails (including the need for
surgery) or until 12 months after starting treatment, whichever is shorter.
Treatment should continue only if there is clear evidence of response as determined by clinical
symptoms, biological markers and investigation, including endoscopy if necessary. People who
continue treatment should be reassessed at least every 12 months to determine whether ongoing
treatment is still clinically appropriate.
A trial withdrawal from treatment should be considered for all patients who are in stable clinical
remission. People whose disease relapses after treatment is stopped should have the option to start
treatment again.
NICE Guidance TA342: Vedolizumab for treating moderately to severely active ulcerative
colitis (June 2015) recommends vedolizumab as an additional treatment option under the same
conditions as laid out in TA 329 (Feb 2015)
NICE Guidance TA352: Vedolizumab for treating moderately to severely active Crohn's
disease after prior therapy recommends vedolizumab as an option for treating moderately to
severely active Crohn's disease only if:
 a tumour necrosis factor‑ alpha inhibitor has failed (that is, the disease has responded
inadequately or has lost response to treatment) or
 a tumour necrosis factor‑ alpha inhibitor cannot be tolerated or is contraindicated.
Notes:
MHRA drug safety update (April 2014): There is an increased risk of tuberculosis, or reactivation of
latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. TNFalpha inhibitors are contraindicated in patients with active tuberculosis or other severe infections.
Patients should be screened patients for active and latent tuberculosis before starting treatment with
a TNF-alpha inhibitor and monitored closely for infectious diseases including tuberculosis before,
during, and after treatment.
1.5.1 Aminosalicylates
Balsalazide

Capsules 750mg
Mesalazine

Olsalazine


Octasa MR - tablets 400mg,
800mg
Pentasa - tablets 500mg,
granules 1g sachet, 2g sachet
Retention enema 1g,
suppositories 1g
Capsules 250mg
Tablets 500mg
Sulfasalazine



Tablets 500mg
EC tablets 500mg
Suspension 250mg/5ml

First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 8 of 14
Notes:
1. Mesalazine tablets are modified release and different brands may have different release
characteristics and, therefore, are not interchangeable. Thus, prescribing should be by brand
name.
2. Mesalazine suppositories are a useful alternative to steroid enemas in maintenance therapy.
3. Sulfasalazine is useful for patients with concomitant arthritis.
4. None of the newer aminosalicylates are any more effective than sulfasalazine, but may cause
fewer side effects.
5. CSM Warning: It is recommended that patients receiving aminosalicylates should be advised to
report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs
during treatment. A blood count should be performed and the drug stopped immediately if there
is a suspicion of a blood dyscrasia.
6. Olsalazine is minimally absorbed in the small bowel and may offer advantages over mesalazine
for distal colitis.
7.
Balsalazide should only be prescribed for patients not responding to other aminosalicylates.
1.5.2 Corticosteroids
 Modified release capsules 3mg
Budesonide
 Foam enema
Hydrocortisone
 Tablets 5mg, 25mg (Non-enteric
Prednisolone


coated)
Enema 20mg
Foam enema 20mg
Notes:
1. Steroids are the most appropriate treatment for acute disease but do not prevent relapse.
2. Hydrocortisone enema is appropriate initial treatment for relapse, but if the symptoms have not
resolved within two weeks, then specialist advice should be sought.
3. Budesonide MR is licensed for the induction of remission in patients with mild to moderate
Crohn’s disease affecting the ileum and / or ascending colon for up to 8 weeks. Refer to BNF or
SPC for full details.
4. Please refer to BNF chapter 6 for other indications of corticosteroids.
1.5.3 Drugs affecting the immune response
 Tablets 25mg, 50mg
Azathioprine
Ciclosporin
 IV infusion 50mg in 1ml, 1ml amp,
Unlicensed use
5ml amp
Methotrexate
Mercaptopurine

Tablets 2.5mg
Unlicensed use


Puri-Nethol® Tablets 50mg
Xaluprine® suspension 20mg in
1ml
Unlicensed use
NB: Tablets and suspension are NOT
bioequivalent
5. Azathioprine and mercaptopurine have a role in maintenance of remission in people with
Crohn’s disease. Methotrexate is also indicated where patients cannot tolerate or have
contraindications to azathioprine and mercaptopurine or where these drugs are ineffective. See
NICE CG152 (October 2012)
6. If switching formulation of mercaptopurine, full haematological monitoring is advised as the
products are not bioequivalent.
7. Ciclosporin has a role in the hospital setting for severe acute ulcerative colitis under specialist
supervision. – see NICE CG166 (June 2013)
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 9 of 14
1.6 Laxatives







It should be remembered that a change in bowel habit might indicate the need for investigation rather
than an automatic prescription.
A digital rectal examination (DRE) may be required to establish if there is faecal matter in the rectum,
the amount and consistency and the need for enemas. Ref RCN guidelines “Digital Rectal examination
and manual removal of faeces” April 2004.
There is little evidence on which to judge the relative effectiveness and tolerability of individual
laxatives. Therefore choice should be based on symptoms, patient preferences, side effects and cost
of medicines.
Care should be taken with bulk forming laxatives. Patients should be advised to take them
immediately with adequate fluid, (ensuring at least 1.5 litres per day).
Lactulose takes up to 48 hours to work but is often inappropriately used “when required”. It is
unpleasant to take and compliance may be a problem. Its main clinical benefit is in the management of
hepatic encephalopathy. It is important to ensure a minimum fluid intake of 1.5 litres per day.
Laxido® should be reserved only for patients where other treatments have been ineffective. Caution:
may cause electrolyte disturbances. (Idrolax® is a polyethylene glycol preparation without
electrolytes if a salt free preparation is required).
Ongoing reassessment of the patient’s bowel habit is essential.
Oral Preparations
 Sachets 3.5g (Fybogel®)
Ispaghula husk
Time of onset
1 – 2 days
Docusate sodium


Lactulose

Capsules 100mg
Paediatric oral solution
12.5mg/5ml, 50mg/5ml
Solution
Bisacodyl

Tablets 5mg
10 – 12 hours
Senna


Tablets 7.5mg sennosides
Syrup 7.5mg sennosides in 5ml
8 – 12 hours
Macrogols (polyethylene
glycols)

Laxido® and Idrolax® Sachets
6 – 12 hours
Sodium picosulfate


Capsules 2.5mg
Elixir 5mg/5ml (paediatrics)
Rectal preparations
Rectal preparations should be used only after careful assessment, (including DRE if appropriate) and
diagnosis of the underlying cause of the constipation.
20 – 60 minutes
 Suppositories 5mg (paediatric), 10mg
Bisacodyl
Glycerol

Suppositories 1g, 2g, 4g
15 – 30 minutes
Sodium citrate

Micro-enema 450mg
5 – 15 minutes
Co-danthramer


Terminally ill patients
Capsules 25/200, 37.5/500
Suspension 25/200 in 5ml, 75/1000 in
5ml
Co-danthrusate


Capsules 50/60
Suspension 50/60 in 5ml
Methylnaltrexone▼

12mg in 0.6ml SC injection
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 10 of 14
1. The CSM (Current Problems in Pharmacovigilance volume 26, May 2000) have advised that the
indications for danthron containing products has been restricted to constipation in terminally ill
patients of all ages. Therefore, co-danthramer and co-danthrusate are included as Specialist
Initiated Drugs.
2. Most terminally ill patients require both a softening agent and a stimulant laxative, for example, codanthrusate (or a cheaper alternative, such as lactulose, may suffice) + senna.
3. Phosphate enemas and arachis oil enemas have not been included as their use has declined with the
availability of polyethylene glycols which are also licensed for the treatment of faecal impaction. Advice
should be sought from the continence service. N.B. arachis oil should not be used in patients with
a nut allergy.
4. Methylnaltrexone is an opioid antagonist licensed for the treatment of opioid induced constipation in
advanced illness patients who are receiving palliative care when response to usual laxative therapy
has not been sufficient.
5. Use of methylnaltrexone is currently restricted to hospices or on the advice of a palliative care
physician.
Guidelines for the Management of Constipation
For guidance on the management of constipation in children and young people see NICE CG 99 Constipation
in children and young people
Where possible stop any drugs likely to cause constipation
Ensure patient is properly positioned when sitting on the toilet as correct posture can make defecation
easier and more comfortable.
Constipation
Dietary advice – high fibre content diets in association with adequate fluid intake (minimum 1.5 litres
per day) are effective in increasing stool weight and bowel movement frequency. It should be tried for
at least a month before its effects are determined. It should be used with caution in patients who have
obstructive symptoms or faecal impaction. Caution: a high fibre diet may increase bloating.
Soft Stool
1. Senna 2 –4 tablets at night PRN
2. Glycerol suppository PRN
3. Sodium Citrate micro-enema PRN
Hard Stool
1. Docusate 100mg TDS
2. Sodium Citrate micro-enema PRN
3. Laxido® sachets. Use 1 to 3 sachets daily in divided
doses in water as per manufacturer’s instructions.
Chronic Constipation
Dietary advice – high fibre content diets in association with adequate fluid intake (minimum 1.5 litres
per day) are effective in increasing stool weight and bowel movement frequency. It should be tried for
at least a month before its effects are determined. It should be used with caution in patients who have
obstructive symptoms or faecal impaction. Caution: a high fibre diet may increase bloating.
The use of laxatives is not always necessary.
However laxative use may be appropriate if:
 No response to dietary changes.
 There is faecal impaction.
 Constipation or painful defecation is associated with illness, surgery or during pregnancy.
 The patient is elderly or has a poor diet.
 Constipation is drug induced.
 Patient has a medical condition in which bowel strain is undesirable.
Also in preparation for investigations or procedures.
Laxatives – The choice of laxative should be based on symptoms, patient preferences, side effects
and the cost. (See table above for formulary choices).
Laxido
®
Faecal impaction
8 sachets in 1000ml water & consumed over 6 hours. Used for 3 days then re-assess.
1.6.5 Bowel cleansing solutions
Klean-Prep®
First line drugs

Oral Powder
Second line drugs
Macrogol based
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 11 of 14
Citramag

Powder, effervescent
Magnesium based
Fleet Phospho-soda®

Oral solution
Phosphate based
Picolax®

Oral Powder
Sodium picosulphate + magnesium
citrate
Note:
With bowel cleaning agents used as preparation for colonoscopy, CT or surgery, fluid intake is
important.
NPSA Rapid Response Report (RRR012) February 2009
The NPSA has issued guidance on procedures for the supply of bowel cleansing agents in order to
reduce the risk of harm to patients from electrolyte imbalance and dehydration. They advise that:
 RRR012/1. A clinical assessment is undertaken by the clinician authorising the surgery or
investigative procedure (including GPs using the direct access route) to ensure that there is no
contraindication (e.g. clinical condition such as diverticulitis) or risks (e.g. concurrent medication
such as diuretics) from the use of a bowel cleansing solution.

RRR012/2. Use of a bowel cleansing solution is authorised by the clinician at the same time as
the surgery or investigative procedure. This may be done by using the same form.

RRR012/3. The clinician requesting the surgery or procedure and authorising the use of a bowel
cleansing solution is responsible for ensuring that an explanation on the safe use of the product is
provided to the patient or carer.

RRR012/4. A safe system exists that involves an authorised clinical professional in the supply of
the medicine and written information (including named contact) for each patient. See
implementation checklist in supporting information for more details on this.
1.6.6 Peripheral opioid receptor antagonists

Relistor® 12mg in 0.6ml SC Only for initiation by a physician with
expertise in palliative care
injection
 Moventig® tablets 12.5mg,
Naloxegol▼
25mg
NICE TA 345 (July 2015) recommends naloxegol 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. If only 1 laxative class has been taken, this should be the stimulant type.
Methylnaltrexone
1.6.7. Other drugs used in Constipation
Linaclotide▼

Lubiprostone

Prucalopride

Constella® Capsules 290
micrograms
Amitiza® Capsules 24
micrograms
Resolor® Tablets 1mg,
2mg
Linaclotide is licensed for use in moderate to severe IBS with constipation. It can be used where
optimal or maximum tolerated doses of previous laxatives from different classes have not helped and
where constipation has been present for at least 12 months. The effectiveness of linaclotide should
be reviewed after 3 months. See NICE Clinical Guideline 61: Irritable Bowel Syndrome in Adults (Feb
2015) for other treatment options.
Lubiprostone and Prucalopride are newer treatments licensed for use in chronic constipation.
Lubiprostone is an option for treating chronic idiopathic constipation, in 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 NICE TA 318 (July 2014)
Prucalopride is licensed for use in women only and 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 invasive treatment for constipation is being considered. NICE TA 211 (Dec 2010)
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 12 of 14
1.7 Local preparations for anal and rectal disorders
1.7.1 Soothing haemorrhoidal preparations
 Cream, 23g
Anusol®
(Soothing preparation)
Anusol HC®
(soothing plus steroid)
Proctosedyl®
(Local anaesthetic plus
steroid)
Xyloproct®






Ointment, 25g
Suppositories
Ointment, 30g
Suppositories
Suppositories
Ointment 30g

Ointment, 30g
(local anaesthetic plus
steroid)
Note:
These preparations are of limited clinical value and should only be used for short periods (not more
than a few days) as they cause sensitisation of the skin. Excessive application of preparations
containing local anaesthetics should be avoided.
1.7.3 Rectal sclerosants
Phenol, Oily

Injection 5% in 5 ml
1.7.4 Management of anal fissures
Glyceryl trinitrate
 rectal ointment 0.4%
1.8 Stoma care
Stoma advice is available from the Stoma Care Clinical Nurse Specialists
1.9 Drugs affecting intestinal secretions
1.9.1 Drugs acting on the gall bladder
 Capsules 250 mg
Ursodeoxy-cholic acid
(Ursofalk®)

Suspension 250mg in 5ml
Note:
Ursofalk® is included as it is licensed for primary biliary cirrhosis.
1.9.2 Bile acid sequestrants
 Questran® sachets 4g
Colestyramine powder
 Questran Light® sachets 4g SF
Note:
Cholestyramine is indicated for pruritis associated with partial biliary obstruction and primary biliary
cirrhosis.
1.9.4 Pancreatin
Pancreatin
First line drugs





Creon® 10,000 capsules
Creon® 25,000 capsules
Creon® 40,000 capsules
Pancrex V® capsules
Pancrex V® Forte Tablets
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 13 of 14
Note:
The CSM has advised of data associating the high-strength pancreatin preparations with the
development of large bowel strictures in children with cystic fibrosis aged between 2 and 13 years and
recommended that the total dose of pancreatic enzyme supplements used in patients with cystic
fibrosis should not usually exceed 10,000 units of lipase per kg body-weight daily.
It is important to ensure adequate hydration at all times in patients receiving higher strength
pancreatin preparations.
Additional NICE Guidance
NG49 (Jul 2016): Non-alcoholic fatty liver disease (NAFLD): assessment and management
NG50 (Jul 2016): Cirrhosis in over 16s: assessment and management
CG141 (Aug 2016): Acute upper gastrointestinal bleeding in over 16s: management
First line drugs
Second line drugs
Specialist drugs
Specialist only drugs
Adapted from Plymouth Area Joint Formulary and East Surrey Joint Formulary
Chapter 1 Gastrointestinal System Page 14 of 14