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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
01.01  Dyspepsia and gastro-oesophageal reflux disease
 note 

PRESCRIBING POINTS FOR DYSPEPSIA AND GASTRO-OESOPHAGEAL REFLUX DISEASE

  • Offer simple advice regarding lifestyle factors that may affect reflux
  • Liquid preparations are more effective than tablets
  • Antacids are best given when symptoms occur or are expected, usually between meals and at bedtime - four or more times daily
  • Antacids, taken at the same time as other drugs, may impair their absorption. They may also damage enteric coatings designed to prevent irritant drugs from dissolving in the stomach
01.01.01  Antacids and simeticone
01.01.01  Aluminium and magnesium containing antacids
Mucogel® (Co-magaldrox 195/220)
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First Choice
Green

Co-magaldrox (magnesium hydroxide 195mg/5mL plus aluminium hydroxide 220mg/5mL) available as Mucogel® (sugar-free suspension) is an effective antacid with a low sodium content (less than 1mmol per 10mL dose).

Restricted Item Restricted off-label use in the management of hypomagnesaemia in adults

 
01.01.01  Antacid preparations containing simeticone
01.01.01  Simeticone alone to top
 note 

See NICE CKS Colic-Infantile for information on the management of infantile colic.

Do not recommend the following (because there is insufficient evidence to support their use):

  • Simeticone (e.g Infacol®) or lactase (e.g Colief®) drops
  • Diet modification (the mother's if breastfeeding, or changing the baby's infant milk formula)
  • Probiotic or herbal supplements
  • Manipulative strategies
01.01.01  Antacid preparations containing dimeticone or local anaesthetics
01.01.02  Compound alginates and proprietary indigestion preparations
01.01.02  Compound alginate preparations
Peptac®
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First Choice
Green

Should be avoided in cardiac failure, renal and hepatic disease as it has a high sodium content (6.2mmol per 10mL dose).

 
Gaviscon Advance®
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Formulary
Green

Oral suspension and chewable tablets

 
Link  SmPC: Gaviscon Advance
   
Gaviscon® Infant
(reflux/regurgitation in infants)
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Formulary
Green

For infants aged 1 to 2 years. Not to be used in premature infants or infants under one year except under medical supervision.

 
Link  SmPC: Gaviscon Infant
Link  NICE CKS: GORD in children
   
01.02  Antispasmodics and other drugs altering gut motility
 note 

PRESCRIBING POINTS FOR ANTISPASMODICS

  • All antispasmodics should be avoided in paralytic ileus
  • Absorption of other drugs may be affected by altering gut transit time
  • The elderly are particularly susceptible to the anti-muscarinic side-effects of antispasmodics and care should be taken in their use
01.02  Antimuscarinics to top
Hyoscine Butylbromide
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Formulary
Green

Prescribe generically
Tablets and injection

 
Link  Drug Safety Update Articles: Hyoscine
Link  Scottish Palliative Care Guidelines
   
01.02  Other antispasmodics
Mebeverine
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First Choice
Green

Prescribe generically
Tablets 135mg 

 
Alverine
(60mg capsules)
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Formulary
Green

Prescribe generically
60mg capsules only
2 x 60mg capsules are more cost-effective than 1 x 120mg capsule

 
   
Peppermint Oil
(0.2mL G/R capsules)
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Formulary
Green

Prescribe generically as Peppermint oil 0.2mL gastro-resistant capsules

 
   
01.02  Motility stimulants
 note 

Domperidone and metoclopramide are no longer used as motility stimulants in conditions such as heartburn etc. For the use of domperidone and metoclopramide for the relief of the symptoms of nausea and vomiting see section 4.6.

01.03  Antisecretory drugs and mucosal protectants
01.03  Helicobacter pylori infection
 note 

PRESCRIBING POINTS FOR HELICOBACTER PYLORI AND PEPTIC ULCER

  • It is recommended that H. pylori is confirmed before starting treatment
  • Patients should be aware that compliance is essential for an effective outcome. They should be warned of potential side-effects. Symptoms do not settle immediately even after successful therapy
  • Confirmation of eradication with a carbon isotope urea breath test requires stopping treatment with PPIs two weeks prior to testing. H2-receptor antagonists are used sometimes to reduce the painful gastric symptoms experienced by patients who must stop PPIs prior to the urea breath test
  • In cases of complicated peptic ulcer, i.e. patients with haemorrhage or perforation - maintenance therapy should only be discontinued once eradication of H. pylori has been confirmed by a carbon isotope urea breath test six weeks after therapy

Table 1: Recommended regimens for Helicobacter pylori eradication for 1 week 
(Note: regimens are based on GI consultant recommendations (based on microbiological resistance and patient compliance) and may differ from BNF recommendations).

TREATMENT (ADULTS) to continue for 7 days

First-line:

Omeprazole 
20mg twice daily
Clarithromycin 
500mg twice daily

Amoxicillin 
1g twice daily

---------

Penicillin allergy 
First-line:

Omeprazole 
20mg twice daily

Clarithromycin 
500mg twice daily

Metronidazole 
400mg twice daily

---------

Second-line:

Omeprazole 
20mg three times daily

Bismuth subsalicylate 
525mg three times daily

Metronidazole 
400mg three times daily

Tetracycline 
500mg three times daily

Third-line/refractory cases - contact Dr Phull

Due to resistance issues if a patient has been treated with clarithromycin in the previous 12 months for any indication consider using a non-clarithromycin based regimen. See NICE guidance (https://www.nice.org.uk/guidance/cg184) or seek local advice for alternatives.

01.03.01  H2-receptor antagonists to top
Ranitidine
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First Choice
Green
 
01.03.03  Chelates and complexes
Bismuth subsalicylate 262.5mg tablets
(Helicobacter pylori eradication (off-label))
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Restricted Drug Restricted
Amber 1

Restricted Item to be used off-label in Helicobacter pylori eradication following failure of standard regimens.

  • Must be prescribed generically
  • Absorption of tetracycline antibiotics can be reduced when concurrently taken with products containing bismuth, this interaction can be minimised by separating the doses of the two drugs by a couple of hours
 
Link  SmPC: Bismuth subsalicylate tablets
   
01.03.05  Proton pump inhibitors (PPIs)
Lansoprazole
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First Choice
Green

Lansoprazole is not licensed for use in children but may be considered where the formulation/presentation is advantageous.

 
Omeprazole
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First Choice
Green
 
Esomeprazole
(injection/infusion)
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Restricted Drug Restricted
Red

Restricted Item to be used:

  • as a gastric antisecretory treatment when the oral route is not possible
  • [adults] where high dose PPI is indicated for the prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers
 
Link  SmPC: Esomeprazole injection/infusion
   
Esomeprazole granules
View childrens BNF
Restricted Drug Restricted
Amber 1

Restricted Item to be used in children aged 1 to 11 years who have nasogastric/PEGgastrostomy tubes and are unable to take medicines orally.

 
Link  SmPC: Esomeprazole granules
   
01.04  Acute diarrhoea
 note 

PRESCRIBING POINTS FOR ANTIDIARRHOEAL DRUGS

  • If clostridium difficile is suspected, all antidiarrhoeals are contraindicated
  • Antibiotics should not be given for acute diarrhoea until an infected cause is diagnosed
  • Diarrhoea may require fluid and electrolyte replacement. This is particularly important in infants and in frail or elderly patients. For oral rehydration preparations, see 9.2.1
  • Patients with chronic diarrhoea need individualised treatment including dietary manipulation as well as drug treatment and maintenance of a liberal fluid intake. This will depend on underlying diagnosis
  • Antidiarrhoeal drugs should not be given to patients with acute colitis as they may cause toxic megacolon
  • Bulk-forming drugs, such as ispaghula are useful in controlling faecal consistency in ileostomy and colostomy patients, and in controlling diarrhoea associated with diverticular disease
  • Antidiarrhoeal drugs which reduce gastro-intestinal motility should not be used in children
  • Oral rehydration is the first line treatment for dehydration in children. Antidiarrhoeal drugs should not be used to treat acute diarrhoea in children under 12 years. In cases of chronic diarrhoea, infection should be excluded before antidiarrhoeal drugs are prescribed.
    Loperamide is preferable to codeine. It is not licensed for use in children under 4 years old. It should not be used for acute infectious diarrhoea. Long-term use, should be managed under close medical supervision.
01.04.02  Antimotility drugs
Loperamide
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First Choice
Green

Capsules 2mg; Oral solution 1mg/5mL
Prescribe generically
Loperamide should be the first-choice antimotility agent for diarrhoea in adults with IBS (NICE CG61)

 
Codeine
(Antidiarrhoeal)
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Formulary
Green

Tablets 15mg, 30mg, Oral solution (25mg/5mL)

Only suitable for short-term use because of the risk of CNS side-effects and dependence.

 
Link  Drug Safety Update Articles: Codeine
   
01.04.03  Enkephalinase Inhibitors to top
01.05  Chronic bowel disorders
 note 

PRESCRIBING POINTS FOR DRUGS USED IN CHRONIC BOWEL DISORDERS

  • Treatment should only be commenced in patients with proven disease
  • Aminosalicylates should be avoided in patients with salicylate hypersensitivity
  • 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 suspicion of a blood dyscrasia
  • Patients with irritable bowel syndrome may benefit from adopting a high fibre diet or taking agents which increase stool bulk (see 1.6)
  • Antispasmodics (see 1.2) may be useful as adjunctive treatment
  • Long-term use of rectal corticosteroids can lead to systemic side-effects

PAEDIATRIC NOTES - CHRONIC BOWEL DISORDERS

  • Recommended drugs may be used in children but should not be used without prior specialist investigation
  • Rectal administration of drugs is suitable only for older children
  • IBD in children is treated according to the BSPGHAN IBD Standards, available at http://www.ibdstandards.org.uk/uploaded_files/IBDstandards.pdf
01.05  Short bowel syndrome
TeduglutideBlack Triangle (Revestive®)
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Restricted Drug Restricted
Red
High Cost Medicine

Restricted Item Treatment should be initiated under the supervision of a medical professional with experience in the treatment of Short Bowel Syndrome (SBS).

 
Link  SMC 1139/16: Teduglutide for the treatment of paediatric patients (aged 1 to 17 years) with short bowel syndrome (SBS) who are stable following a period of intestinal adaptation after surgery (April 2018)
Link  SMC 2225: Teduglutide for the treatment of adult patients with short bowel syndrome (SBS) who are stable following a period of intestinal adaptation after surgery (Feb 2020)
   
01.05.01  Aminosalicylates
Mesalazine (Salofalk®)
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First Choice
Amber 1
  • Salofalk® is the first-line agent for new patients (at doses of 1.5g maintenance and 1.5 - 3g acute episodes)
  • where Salofalk® is not suitable, alternative formulary choices for new patients are Pentasa® and Octasa®
  • Octasa® and Asacol® are bioequivalent
 
Sulfasalazine
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Formulary
Amber 1
 
   
Balsalazide Sodium (Colazide®)
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Restricted Drug Restricted
Amber 2

Restricted Item to be used as a second-line treatment in patients with distal colitis.

 
   
01.05.02  Corticosteroids
Prednisolone
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Formulary
Amber 1
 
   
Budesonide (Budenofalk®)
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Formulary
Amber 1
 
   
Budesonide (Entocort®)
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Formulary
Amber 1
 
   
01.05.02  Oral to top
01.05.02  Topical
01.05.02  Parenteral
01.05.03  Drugs affecting the immune response
Cytotoxic Drug Azathioprine
(Gastroenterology)
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Formulary
Amber 2
 
   
Cytotoxic Drug Mercaptopurine
(Gastroenterology)
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Formulary
Amber 2
 
Link  Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
   
Cytotoxic Drug Methotrexate
(Gastroenterology (off-label))
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Restricted Drug Restricted
Amber 2
 
   
Tofacitinib citrateBlack Triangle (Xeljanz® 5mg and 10mg tablets)
(ulcerative colitis)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

RMM Risk Minimisation Materials

31/10/2019: EMA’s safety committee (PRAC) is recommending that:

  1. tofacitinib should be used with caution in patients at high risk of blood clots
  2. the maintenance doses of 10mg twice daily should not be used in patients with ulcerative colitis who are at high risk unless there is no suitable alternative treatment
  3. patients older than 65 years of age should be treated with tofacitinib only when there is no alternative treatment., see PRAC press release.

Restricted Item Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of ulcerative colitis.

 
Link  Risk Minimisation Materials
Link  31/10/2019 EMA - Xeljanz (Tofacitinib) to be used with caution for all patients at high risk of blood clots
Link  Drug Safety Update Articles: Tofacitinib
Link  SMC 2122: Tofacitinib for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (Feb 2019)
   
Ciclosporin
(Gastroenterology)
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Restricted Drug Restricted
Red

Restricted Item continuous intravenous infusion to be used only

 
   
01.05.03  Biologics
 note 

Biological medicines, including biosimilar medicines, should be prescribed by both generic and brand name and the brand name and batch number should be recorded on the patient’s prescription, case record or other appropriate clinical system.

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the condition.

Where one or more option is available treatment should routinely be started with the least expensive option.

Amgevita® (Adalimumab)
(50mg/mL subcutaneous injection; Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

SMC Risk Minimisation Materials

Amgevita® 50mg/mL is the preferred biosimilar of adalimumab.

  • Amgevita 20mg solution for injection in pre-filled syringe
  • Amgevita 40mg solution for injection in pre-filled syringe and pre-filled pen
 
Link  Risk Minimisation Materials
Link  NICE TA329: Adalimumab for the treatment of moderately to severely active ulcerative colitis after the failure of conventional therapy (Feb 2015)
Link  SMC 880/13: Adalimumab for the treatment of severe active Crohn’s disease in paediatric patients (6 to 17 years of age) (July 2013)
Link  NICE TA187: Adalimumab for the treatment of severe active Crohn’s disease (May 2010)
   
Remsima® (Infliximab)
(100mg concentrate for infusion; Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

RMM Risk Minimisation Materials

Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated. Patients treated with Remsima should be given the package leaflet and the patient reminder card.

Remsima® is the preferred biosimilar of infliximab intravenous infusion.

 
Link  Risk Minimisation Materials
Link  SmPC: Remsima concentrate for infusion
Link  NICE TA187: Infliximab for the treatment of active Crohn’s disease [6 years and over] (May 2010)
Link  NICE TA329: Infliximab for the treatment of moderately to severely active ulcerative colitis after the failure of conventional therapy [6 years and over] (Feb 2015)
   
Remsima® (Infliximab)
(120mg subcutaneous injection; Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

RMM Risk Minimisation Materials

Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated. Patients treated with Remsima should be given the package leaflet and the patient reminder card.

Remsima® is the preferred biosimilar of infliximab subcutaneous injection.

Restricted Item Only for the maintenance treatment of:

  • severe active Crohn's disease or active fistulising Crohn's disease in adults whose disease has not responded to conventional therapy, or who are intolerant of or have contraindications to conventional therapy, in line with SMC and Healthcare Improvement Scotland advice for the reference intravenous infliximab product (TA187)
  • ulcerative colitis in adults whose disease has responded inadequately to, is intolerant of or has contraindications to conventional therapy, in line with SMC and Healthcare Improvement Scotland advice for the reference infliximab intravenous infusion product (TA329)
 
Link  Risk Minimisation Materials
Link  SmPC: Remsima solution for injection in pre-filled pen/syringe
Link  NICE TA187: Infliximab for the treatment of active Crohn’s disease (May 2010)
Link  NICE TA329: Infliximab for the treatment of moderately to severely active ulcerative colitis after the failure of conventional therapy (Feb 2015)
   
Golimumab (Simponi®)
(100mg/mL subcutaneous injection; Ulcerative colitis)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

RMM Risk Minimisation Materials

 
Link  Risk Minimisation Materials
Link  NICE TA329: Golimumab for the treatment of moderately to severely active ulcerative colitis after the failure of conventional therapy (Feb 2015)
   
Ustekinumab (Stelara®)
(90mg/mL subcutaneous injection; Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

Ustekinumab is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which ustekinumab is indicated.

 
Link  SmPC: Ustekinumab solution for injection
Link  Drug Safety Update Articles: Ustekinumab
Link  SMC 1250/17: Ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease after the failure of conventional therapy (July 2017)
Link  SMC 2250: ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis who have failed to respond to, are intolerant to, or have a contraindication to conventional or biologic therapies (April 2020)
   
Ustekinumab (Stelara®)
(130mg concentrate for infusion; Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine

Ustekinumab concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.

Restricted Item Ustekinumab concentrate for solution for infusion should only be used for the intravenous induction dose.

 
Link  SmPC: Ustekinumab concentrate for solution for infusion
Link  Drug Safety Update Articles: Ustekinumab
Link  SMC 1250/17: Ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease (July 2017)
Link  SMC 2250: ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis who have failed to respond to, are intolerant to, or have a contraindication to conventional or biologic therapies (April 2020)
   
Vedolizumab (Entyvio®)
(300mg concentrate for infusion; Gastroenterology)
View adult BNF
Restricted Drug Restricted
Red
High Cost Medicine

RMM Risk Minimisation Materials

Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease.

Restricted Item Adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

For the induction and maintenance treatment of adults with moderately to severely active:

  • ulcerative colitis as per SMC 1045/15; adults who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.
  • Crohn's disease as per SMC 1064/15; adults who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.
 
Link  Risk Minimisation Materials
Link  SmPC: Vedolizumab powder for concentrate for solution for infusion
   
Vedolizumab (Entyvio®)
(108mg subcutaneous injection; Gastroenterology)
View adult BNF
Restricted Drug Restricted
Red
High Cost Medicine
Homecare

RMM Risk Minimisation Materials

Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease.

Restricted Item Adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Only for the maintenance treatment of adults with moderately to severely active:

  • ulcerative colitis in line with SMC 1045/15; adults who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.
  • Crohn's disease in line with SMC 1064/15; adults who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.
 
Link  Risk Minimisation Materials
Link  SmPC: Vedolizumab solution for injection in pre-filled pen/syringe
   
01.06  Laxatives to top
 note 

PRESCRIBING POINTS FOR LAXATIVES

  • Increasing the intake of dietary fibre and fluids with and between meals is more beneficial in the long term than the use of laxatives
  • Laxatives should generally be avoided except where straining will exacerbate a condition or increase the risk of rectal bleeding
  • All stimulant laxatives are unsuitable for long-term use. They can precipitate the onset of an atonic non-functioning colon and significant electrolyte imbalance
  • Bulk laxatives may take several days to have an effect
  • Lactulose may take up to 48 hours to act. It is therefore unsuitable for relief of acute symptoms. It should not be used routinely in the elderly and should be avoided if the stool is already soft.
  • Stimulant laxatives should be avoided in pregnancy
  • Stimulant laxatives increase gut motility and may cause cramps
  • Senna preparations should not be used by breast-feeding mothers as they cause diarrhoea in the baby
  • Rectal administration is unpleasant for children and should be avoided wherever possible
  • Constipation in frail immobile patients is most often due to lack of push and stimulant laxatives are then most useful
01.06.01  Bulk-forming laxatives
Ispaghula Husk
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Formulary
Green
 
   
01.06.02  Stimulant laxatives
Senna
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First Choice
Green
 
Docusate
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Formulary
Green
 
   
Glycerol (Glycerin)
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Formulary
Green
 
   
Bisacodyl
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Formulary
Green
 
   
Sodium Picosulfate
Formulary
Green
 
   
Co-danthramer
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Restricted Drug Restricted
Amber 1

Restricted Item use is restricted to prophylaxis and treatment of analgesic-induced constipation in terminally ill patients.

 
   
Co-danthrusate
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Restricted Drug Restricted
Amber 1

Restricted Item use is restricted to prophylaxis and treatment of analgesic-induced constipation in terminally ill patients.

 
   
01.06.02  Other Stimulant laxatives
01.06.03  Faecal softeners
01.06.04  Osmotic laxatives to top
Macrogol oral powder
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Formulary
Green
 
   
Lactulose
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Formulary
Green
 
   
01.06.05  Bowel cleansing preparations
Sodium picosulfate
(bowel cleansing agents)
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Restricted Drug Restricted
Amber 1

Sodium picosulfate bowel cleansing agents, e.g. Picolax®

Restricted Item to be used prior to radiological examination, endoscopy or surgery of the bowel.

Note: It is NOT to be used as a treatment for constipation.

 
Link  SmPC: Sodium picosulfate bowel cleansing agents (Picolax)
   
Macrogol (Klean-Prep®)
(bowel cleansing agents)
View adult BNF
Restricted Drug Restricted
Amber 1

Restricted Item to be used before colonic surgery, colonoscopy or radiological examination.

Note: It is NOT to be used as a treatment for constipation.

 
Link  SmPC: Macrogol bowel cleansing agents (Klean-Prep)
   
Macrogol (Moviprep®)
(bowel cleansing agents)
View adult BNF
Restricted Drug Restricted
Red

Restricted Item to be used in combination with preoperative oral antibiotics prior to elective colorectal surgery in adults.

Note: It is NOT to be used as a treatment for constipation.

 
Link  SmPC: Macrogol bowel cleansing agents (Moviprep, moviprep orange)
   
01.06.06  Peripheral opioid-receptor antagonist
Methylnaltrexone (Relistor®)
View adult BNF View SPC online
Restricted Drug Restricted
Red

Restricted Item It is restricted to use by physicians with expertise in palliative care.

 
Link  SMC 518/08: Relistor for treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient (Dec 2008)
   
01.06.07  Other drugs used in constipation
Linaclotide (Constella®)
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Restricted Drug Restricted
Amber 1

Restricted Item Recommended by Consultant Gastroenterologist only, for patients with moderate to severe irritable bowel syndrome with constipation (IBS-C) who have not responded adequately to or cannot tolerate all other suitable treatment options

 
Link  SMC 869/13: Moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults, June 2013
   
Prucalopride
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Restricted Drug Restricted
Amber 1

For the treatment of chronic constipation only in adults 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.

Restricted Item Treatment should only be initiated in Primary Care following prescribing recommendation by the Departments of Digestive Disorders or General Surgery.

If treatment with prucalopride is not effective after 4 weeks, the patient should be re-examined and the benefit of continuing treatment reconsidered.

 
   
01.06.08  Other preparations for bowel obstruction
01.07  Local preparations for anal and rectal disorders to top
 note 

PRESCRIBING POINTS FOR ANO-RECTAL PREPARATIONS

  • Local anaesthetics should be used for short periods only (no longer than a few days) as they may produce skin sensitisation
  • Rectal ointments, creams and suppositories are usually used night and morning, and after a bowel movement
  • When used for fissures, these products are best applied with a dilator to ensure contact with the base of the fissure
  • Diltiazem 2% cream or glyceryl trinitrate ointment are applied twice daily
  • Excessive application of glyceryl trinitrate olintment will cause side-effects (headache, flushing, dizziness, postural hypotension)
  • Rectal preparations are rarely used in children and are unlicensed for paediatric use
01.07.01  Soothing haemorrhoidal preparations
Anusol®
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Formulary
Green
 
   
01.07.02  Compound haemorrhoidal preparations with corticosteroids
Proctosedyl® suppository
View adult BNF View SPC online
Formulary
Green
 
   
Xyloproct® ointment
View adult BNF View SPC online
Formulary
Green
 
   
01.07.03  Rectal sclerosants
Oily phenol injection BP
(haemorrhoids)
View adult BNF View SPC online
Restricted Drug Restricted
Red
 
   
01.07.04  Management of anal fissures
Diltiazem Cream 2%
(Anal fissures)
Restricted Drug Restricted
Green

unlicensed Unlicensed product

 
   
Glyceryl trinitrate Ointment 0.2%
(Anal fissures)
Restricted Drug Restricted
Amber 1

unlicensed Unlicensed product

 
   
Botulinum toxin type A
(Anal fissures (off-label))
View adult BNF View SPC online
Restricted Drug Restricted
Red

Restricted Item to be used for internal anal sphincter injection and may only be administered by physicians with appropriate qualifications, and expertise in the use of botulinum toxin and in the use of the required equipment.

 
   
01.09  Drugs affecting intestinal secretions to top
01.09.01  Drugs affecting biliary composition and flow
Ursodeoxycholic acid
(250mg capsules)
View adult BNF View SPC online
First Choice
Amber 1

Adults: primary biliary cirrhosis and for the dissolution of radiolucent gallstones

  • Prescribe generically
  • 250mg capsules are the preferred choice of formulation
  • 2 x 250mg capsules are more cost effective than 1 x 500mg capsule
 
Obeticholic acidBlack Triangle (Ocaliva®)
(primary biliary cirrhosis)
View adult BNF View SPC online
Restricted Drug Restricted
Red
High Cost Medicine
Homecare

Restricted Item In combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid

 
Link  Drug Safety Update Articles: Obeticholic acid
Link  SMC 1232/17: Obeticholic acid as monotherapy or in combination with ursodeoxycholic acid, for the treatment of primary biliary cholangitis in adults (June 2017)
   
Ursodeoxycholic acid
View SPC online View childrens BNF
Restricted Drug Restricted
Amber 1

Restricted Item to be used in paediatric patients with chronic liver disease, e.g. cystic fibrosis or neonatal cholestasis

 
   
Ursodeoxycholic acid 250mg/5mL
(Oral suspension)
View adult BNF View SPC online View childrens BNF
Restricted Drug Restricted
Amber 1

Restricted Item Oral solution is restricted to use in adults, children and adolescents who are unable to swallow capsules.

 
   
01.09.01  Other preparations for biliary disorders
01.09.02  Bile acid sequestrants
Colestyramine
View adult BNF View SPC online View childrens BNF
Formulary
Amber 1
 
   
Colesevelam 625mg capsules (Cholestagel®)
((off-label) bile acid induced diarrhoea)
View adult BNF View SPC online
Restricted Drug Restricted
Blue

Amber 1
Restricted Item Restricted to initiation by a Gastroenterologist for the off-label treatment of bile acid induced diarrhoea as an alternative to cholestyramine.

Black colesevelam (Cholestagel®) is not recommended for use in NHS Scotland for the treatment of primary hypercholesterolaemia as per SMC 451/08 and SMC 690/11

 
Link  NICE Evidence Summary: Bile acid malabsorption: colesevelam
   
01.09.03  Aprotinin
01.09.04  Pancreatin to top
 note 

PRESCRIBING POINTS FOR DRUGS AFFECTING INTESTINAL SECRETIONS

  • With the exception of Creon® 25 000, high-strength pancreatin preparations have been associated with reports of colonic strictures in children aged between 2 and 13 years. The CSM has recommended that;
    • Pancrease HL®, Nutrizym 22® should not be used in children with cystic fibrosis aged 15 years or less
    • 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
    • If a patient on any pancreatin preparation develops new abdominal symptoms (or any change in existing abdominal symptoms) the patient should be reviewed to exclude the possibility of colonic damage
  • Ensure adequate hydration at all times in patients taking higher-strength pancreatin preparations
  • The aim of treatment with pancreatic supplements is to control steatorrhoea and promote growth or weight gain. Treatment is adjusted to suit individual need
  • As well as being used to treat malabsorption in patients with pancreatic exocrine deficiency, supplements are also used in an attempt to treat the pain of chronic pancreatitis, whether or not it is associated with steatorrhoea. Their efficacy in this is not well proven. [Unlicensed indication]
  • Pancreatin is inactivated by gastric acid and so high doses are required. Adding an antisecretory drug, such as an H2-receptor antagonist, may help patients unresponsive to high doses of pancreatin
  • Pancreatin is inactivated by heat and so care is needed if preparations are mixed with food or drink
Pancreatin (Creon® )
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Formulary
Amber 1
 
   
Pancreatin (Creon® Micro)
View SPC online View childrens BNF
Formulary
Amber 1

Alternative formulation suitable for young infants who are unable to swallow capsules, see SPC for information. The granules should not be added to the baby's bottle.

 
   
Pancreatin (Pancrex® V)
View adult BNF View SPC online View childrens BNF
Formulary
Amber 1
 
   
 ....
 Non Formulary Items
Alverine
(Spasmonal®, Spasmonal Forte®, Audmonal®, Audmonal Forte®)

Non Formulary
Black

Prescribe generically as alverine 60mg capsules
2 x 60mg capsules are more cost-effective than 1 x 120mg capsule

 
Budesonide  (Jorveza®)
(eosinophilic esophagitis)

View adult BNF
Non Formulary
Grey

The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.

Link  SmPC: Jorveza
Link  SMC 2158: budesonide for the treatment of eosinophilic oesophagitis (EoE) in adults (older than 18 years of age) who have been unsuccessfully treated with proton pump inhibitors (Oct 2020)
 
Chenodeoxycholic acid Black Triangle  (Chenodeoxycholic acid Leadiant®)
(cerebrotendinous xanthomatosis)

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Non Formulary
Black
High Cost Medicine

Chenodeoxycholic acid Lediant® is not recommended for use within NHS Scotland as per SMC 2190

Treatment must be initiated and monitored by physicians experienced in the management of CTX or inborn errors of primary bile acid synthesis.

 
Co-Phenotrope  (Lomotil®)

Non Formulary
Black

Each tablet contains 2.5mg of diphenoxylate hydrochloride (opioid, synthetic derivative of pethidine) and 0.025mg of atropine sulphate

The combination of diphenoxylate hydrochloride and atropine is not recommended, it frequently causes side-effects. Overdosage is particularly dangerous in children.

 
Darvadstrocel Black Triangle  (Alofisel®)

View adult BNF View SPC online
Non Formulary
Black

RMM Risk Minimisation Materials

Darvadstrocel (Alofisel®) is not recommended for use within NHS Scotland as per SMC 2115

Link  Risk Minimisation Materials
Link  SMC 2115: Darvadstrocel for the treatment of complex perianal fistulas in adult patients with non-active / mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy (July 2019)
 
Dicycloverine

View adult BNF View SPC online View childrens BNF
Non Formulary
Black
High Cost Medicine

Cost-effective alternatives preferred (dicyloverine 10mg three time day costs: tablets >£2,000 per annum; liquid ~£9,000 per annum (Dec 2017)).

Not recommended in NICE CG37 for the treatment of colic in infants due to side effects such as breathing difficulties and coma (see section 1.4.38).

 
Eluxadoline Black Triangle  (Truberzi®)

View adult BNF View SPC online
Non Formulary
Black

Eluxadoline (Truberzi®) is not recommended for use within NHS Scotland as per SMC 1292/18

Link  SMC 1292/18: Eluxadoline in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) (Jan 2018)
 
Fybogel® Mebeverine

Non Formulary
Black

Prescribe generically as individual components (3.5g ispaghula husk BP and mebeverine HCl 135mg)

 
Hydrocortisone acetate 10% w/w rectal foam  (Colifoam®)

Non Formulary
Black

The Marketing Authorisation holder has discontinued this product.

 
Kaolin and Morphine Mixture

Non Formulary
Black

Blackandwhite Kaolin and Morphine Mixture BP is considered less suitable for prescribing

 
Loperamide  (Imodium®)

Non Formulary
Black

Prescribe generically, loperamide 2mg capsule is the most cost-effective formulation

 
Loperamide  (Imodium® Plus)

Non Formulary
Black

Each tablet/caplet contains loperamide hydrochloride 2mg and simeticone equivalent to 125mg dimeticone

 
Lubiprostone  (Amitiza®)

Non Formulary
Black

The Marketing Authorisation holder has discontinued this product.

 
Maalox Plus

Non Formulary
Black
 
Maalox®
(Co-magaldrox 200/175 )

Non Formulary
Black

Maalox® is not the preferred choice simple antacid, prescribe as Mucogel® (Co-magaldrox 195/220).

Note: the formulation of Maalox® has changed it now has a marginally lower aluminium content and higher magnesium content (magnesium hydroxide 200mg/5mL plus aluminium hydroxide 175mg/5mL).
The dose has not changed but the pack size has halved with only a marginal drop in price (was £3.35 for 500mL, now £2.33 for 250mLs*)
The shelf-life once opened has changed from 28 days to 6 months.

Taking account of the new price and smaller pack size, the price per dose of Maalox® has increased by about 40%. The new Maalox® formulation is now approximately 1.6 times more expensive than Mucogel®.

*Costs correct January 2020.

 
Mebeverine  (Colofac®)

Non Formulary
Black

Prescribe generically as Mebeverine 135mg tablets, more expensive if prescribed as Colofac 135mg or Colofac IBS. 

 
Mebeverine modified-release  (Colofac® MR 200mg capsules)

Non Formulary
Black

Mebeverine HCl 135mg tablets preferred

 
Naldemedine Black Triangle  (Rizmoic®)

View adult BNF View SPC online
Non Formulary
Grey
Link  SMC 2242: naldemedine for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative (April 2020)
 
Peppermint Oil
(0.2mL G/R modified-release capsules)

View adult BNF View SPC online View childrens BNF
Non Formulary
Black

Prescribe generically see formulary choice above; more expensive if prescribed as Colpermin®, Colpermin® IBS relief, or peppermint oil 0.2mL gastro-resistant modified-release capsules.
Colpermin® contains arachis oil (peanut oil) BP.

 
Racecadotril  (Hidrasec®)

View adult BNF View SPC online View childrens BNF
Non Formulary
Black

Racecadotril (Hidrasec) is not recommended for use within NHS Scotland as per SMC 818/12 and SMC 832/12

Link  SMC 818/12: Racecadotril as complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children (Aug 2014)
Link  SMC 832/12: Racecadotril for the symptomatic treatment of acute diarrhoea in adults when causal treatment is not possible (Dec 2012)
 
Rectogesic® Rectal Ointment  (Glyceryl Trinitrate 0.4%)

View adult BNF View SPC online
Non Formulary
Black

Glyceryl trinitrate 0.4% ointment (Rectogesic®) is not recommended for use within NHS Scotland for relief of pain associated with chronic anal fissure as per SMC 200/05

Link  SMC 200/05: Rectogesic is not recommended for use in NHS Scotland for the relief of pain associated with chronic anal fissure
 
Rowachol®

Non Formulary
Black

Blackandwhite Rowachol® is considered less suitable for prescribing

 
Simeticone
(Dentinox® Infant Colic Drops, Infacol®)

Non Formulary
Black

Blackandwhite Simeticone (Dentinox® Infant Colic Drops, Infacol®) is considered less suitable for prescribing due to insufficient evidence to support use in infantile colic.

 
Tripotassium Dicitratobismuthate  (De-Noltab®)

Non Formulary

Astellas discontinued De-Noltab (tri-potassium di-citrato bismuthate) tablets from 31 December 2015.

 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Homecare
Homecare

Traffic Light Status Information

Status Description

Green

General use.
Treatment may be initiated in either Primary or Secondary Care.  

Amber 1

Available for restricted use under specialist supervision.
Treatment may be initiated in Primary Care on the recommendation of a consultant/specialist.  

Amber 2

Available for restricted use under specialist supervision.
Treatment to be initiated in hospital prior to handover.  

Red

Hospital use only.
Treatment should be supplied by the hospital for the duration of the treatment course.  

Blue

Products shown as blue have multiple indications with varying formulary classifications. For further information see text next to the product.  

Grey

Work is ongoing and will be reviewed at a future meeting  

Non Formulary

Not routinely available in NHS Grampian however if local need is identified:
  • Contact the Pharmacist Team Leader/Principal Pharmacist – Supply (ARI)
  • Treatment is available:
    • From a Specialist Centre in another health board
    • From the National Specialist Service for pulmonary arterial hypertension (Scottish Pulmonary Vascular Unit or similar specialists)
    • Through the National Services Scotland:
      • Ultra-Orphan Medicines Risk Share Scheme
      • Inherited Metabolic Disorders Risk Share Scheme
    • For SMC recommended medicines/indications where local clinical experts do not wish to add to the formulary at this time
  

Black

Not routinely available in NHS Grampian.
Includes medicines/indications that:
  • Are not recommended for use within NHS Grampian
  • Are not recommended for use within NHS Scotland
  • Have not been considered by SMC or NHSG Formulary Group
  • Are not recommended for use at present due to limited clinical and/or cost effective data
  • There is a local preference for alternative medicines
  

netFormulary