NI Medicines Management Formulary (Adult)BNF Chapter 1 – Gastrointestinal System

NI Medicines Management Formulary

Gastro-intestinal System

(Adult)

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Approval Process

Date Version

Prescribing Guidance Editorial Group

- electronic correspondence

- discussed at PGEG meeting

1/2/12 1.0

30/9/14 2.0

Pending review 3.0

Dissemination to HSC

Areas Date Version

HSCB Internet and Primary Care Intranet

1/2/12 1.0

Northern Ireland Formulary website 30/1/15 2.0

Pending review 3.0

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Gastro-intestinal System

BNF Chapter 1

1.11.1.11.1.2

Dyspepsia and gastro-oesophageal reflux diseaseAntacids and simeticoneCompound alginates and proprietary indigestion preparations

1.2 Antispasmodics and other drugs altering gut motility

1.31.3.11.3.51.3.5a

Antisecretory drugs and mucosal protectantsH2-receptor antagonistsProton pump inhibitorsH.pylori eradication

1.4 Acute diarrhoea

1.51.5.11.5.2

Chronic bowel disordersAminosalicylatesCorticosteroids

1.6 Laxatives

1.71.7.11.7.21.7.4

Local preparations for anal and rectal disordersSoothing haemorrhoidal preparationsCompound haemorrhoidal preparations with corticosteroidsManagement of anal fissures

1.91.9.4

Drugs affecting intestinal secretionsPancreatic Exocrine Insufficiency

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1.1 Dyspepsia and gastro-oesophageal reflux disease (GORD)

For more information see BNF Chapter 1

1.1.1 Antacids and simeticone

1st choice Co-magaldrox 195/220 (Mucogel® suspension)

Dose: 10-20ml three times daily, 20-60 minutes after meals, and at bedtime or when required

Sugar-free, low Na+

Pack Size: 500ml

1.1.2 Compound alginates and proprietary indigestion preparations

1st choice Peptac® suspension

Dose: 10-20ml after meals and at bedtime

Sugar-free, contains sodium bicarbonate 133.5mg (3.1mmol Na+/5ml)

Pack Size: 500ml peppermint or aniseed flavour

Prescribing Notes

Multi-ingredient GI preparations such as Peptac® should not be prescribed generically

Antacids are best given when symptoms occur or are expected, usually between meals and at bedtime

Antacids should preferably not be taken at the same time as other

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drugs since they may impair absorption and can damage enteric coatings designed to prevent dissolution in the stomach

Use a low sodium content preparation for patients suffering from hypertension or heart failure, e.g. co-magaldrox

Compound alginic acid preparations are less powerful antacids than co-magaldrox but may be more effective for heartburn. They are significantly more expensive than simple antacids

Antacids may be useful to be taken as required when patients are stepping down or stopping treatment with long-term PPI/acid suppression therapy

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1.2 Antispasmodics and other drugs affecting drug motility

For more information see BNF 1.2

Antispasmodics

1st choice Mebeverine tablets 135mg

Dose: 1 tablet three times daily preferably 20 minutes before meals

2nd choice Peppermint oil capsules (Mintec® enteric coated capsules)

Dose: 1-2 capsules swallowed whole with water, three times daily before meals for up to 2-3 months if necessary

Prescribing Notes

Mebeverine and peppermint oil are less likely to cause adverse anti-cholinergic effects compared with hyoscine butylbromide and dicycloverine

Dicycloverine tablets and liquid both cost £180 per pack (June 2018) – see Drug Tariff for latest prices

Management of Irritable Bowel Syndrome (IBS)

See NICE CG 61 for the management of irritable bowel syndrome

Consider low dose amitriptyline (10-30mg daily) for abdominal pain associated with irritable bowel syndrome [unlicensed indication]

Consider linaclotide for people with IBS only if (NICE CG61):o optimal or maximum tolerated doses of previous laxatives

from different classes have not helped ando they have had constipation for at least 12 monthso follow up on people taking linaclotide after 3 months

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Consider eluxadoline for treating IBS with diarrhoea only if (NICE TA471):

o the condition has not responded to other pharmacological treatments (for example, antimotility agents, antispasmodics, tricyclic antidepressants) or

o pharmacological treatments are contraindicated or not tolerated, and

o it is started in secondary care

Caution

Older patients are particularly susceptible to the anticholinergic effects of the antimuscarinic antispasmodics (atropine sulphate, dicycloverine hydrochloride, hyoscine butylbromide, propantheline bromide)

Use antimuscarinic antispasmodics with caution in patients with GORD, diarrhoea, ulcerative colitis, myocardial infarction and hypertension

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Motility Stimulants

*ADD JUMP TO ANTI-EMETIC SECTION*

Prescribing Notes

Following restrictions on the use of domperidone and metoclopramide, there are no drugs on the UK market licensed as prokinetic agents

Domperidone is associated with a small risk of serious cardiac side effects. Its use is now restricted to the relief of symptoms of nausea and vomiting and the dosage and duration of use have been reduced. Treatment should generally only be given for up to one week. Domperidone is contraindicated in those with underlying cardiac conditions and other risk factors. For further information see MHRA

Metoclopramide is associated with neurological effects such as short-term extrapyramidal disorders and tardive dyskinesia. In order to minimise the risk of such side effects, metoclopramide should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease. It should only be prescribed for short-term use (up to 5 days) for prevention of postoperative nausea and vomiting; radiotherapy-induced nausea and vomiting; delayed (but not acute) chemotherapy-induced nausea and vomiting; and symptomatic treatment of nausea and vomiting, including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics). For further information see MHRA

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1.3 Antisecretory drugs and mucosal protectants

For more information see BNF Chapter 1

1.3.1 H2-receptor antagonists

1st choice Ranitidine tablets 150mg, 300mg; effervescent tablets 150mg, 300mg; oral solution 75mg/5ml

Doses:

gastric or duodenal ulcer, chronic episodic dyspepsia, NSAID-associated ulcer: 150mg twice daily or 300mg at night

in duodenal ulcer, 300mg can be given twice daily for 4 weeks to achieve a higher healing rate

prophylaxis of NSAID-associated ulcer (unlicensed indication), 300mg twice daily

GORD, 150mg twice daily or 300mg at night

Cautions

H2-receptor antagonists might mask the symptoms of gastric cancer. Particular care is required in patients presenting with 'alarm features' (add ‘Jump to’ Alarm features box). In such cases gastric malignancy should be ruled out before treatment

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Alarm Features

NICAN Northern Ireland Referral Guidance for Suspected Cancer (www.cancerni.net)

Red flag referral for endoscopy / referral to specialist, patients of any age with dyspepsia and any of the following:◦ Chronic gastrointestinal bleeding◦ Dysphagia◦ Progressive unintentional weight loss◦ Persistent vomiting◦ Iron deficiency anaemia◦ Epigastric mass◦ Suspicious barium meal results

Red flag referral for patients presenting with:◦ Dysphagia◦ Unexplained upper abdominal pain and weight loss, with or

without back pain◦ Upper abdominal mass without dyspepsia◦ Obstructive jaundice (depending on clinical state) – consider

urgent ultrasound if available

Consider red flag referral for patients presenting with:◦ Persistent vomiting and weight loss in the absence of dyspepsia◦ Unexplained weight loss or iron deficiency anaemia in the

absence of dyspepsia◦ Unexplained worsening of dyspepsia and:

▪ Barrett’s oesophagus▪ Known dysplasia, atrophic gastritis or intestinal metaplasia▪ Peptic ulcer surgery over 20 years ago

Urgent endoscopy:◦ Patients aged 55 years and older with unexplained and

persistent recent-onset dyspepsia alone

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1.3.5 Proton Pump Inhibitors

1st choice Lansoprazole capsules 15mg, 30mg

Doses (see BNF for full details):

GORD, 30mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed; maintenance 15-30mg daily

Benign gastric ulcer, 30mg daily in the morning for 8 weeks

Duodenal ulcer, 30mg daily in the morning for 4 weeks; maintenance 15mg daily

NSAID-associated duodenal or gastric ulcer, 30mg once daily for 4 weeks, continued for further 4 weeks if not fully healed; prophylaxis, 15-30mg once daily

Acid-related dyspepsia, 15 to 30mg daily in the morning for 2 to 4 weeks

Or

Omeprazole capsules 10mg, 20mg

GORD, 20mg once daily for 4 weeks, continued for further 4-8 weeks if not fully healed; 40mg once daily has been given for 8 weeks in GORD refractory to other treatment; maintenance 20mg once daily

Benign gastric and duodenal ulcers, 20mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration; in severe or recurrent cases increase to 40mg daily

NSAID-associated duodenal or gastric

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ulcer and gastroduodenal erosions, 20mg once daily for 4 weeks, continued for further 4 weeks if not fully healed; prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers, gastroduodenal lesions, or dyspeptic symptoms who require continued NSAID treatment, 20mg once daily

Acid-related dyspepsia, 10-20mg once daily for 2 to 4 weeks

Prescribing Notes

Refer to NICE clinical guideline on Dyspepsia and gastro-oesophageal reflux disease (2014) here

Omeprazole capsules should be prescribed rather than tablets. Tablets are a more expensive formulation with no additional benefit

When initiating a PPI, the duration of treatment should be specified where possible

With the exception of people with Barrett’s Oesophagus, PPIs should be ‘stepped down’ to the minimum dose that maintains symptom control in suitable patients. If the need for ongoing ther-apy is not reviewed, patients may continue to take unnecessarily high doses of PPIs or continue treatment beyond therapeutic need and may, therefore, be at risk of adverse effects associated with long-term use (see cautions box). Refer to stepdown SOP on primary care intranet

Orodispersible tablets should be reserved for patients with swallow-ing difficulties or who require a PPI via a naso-gastric (NG) or per-cutaneous endoscopic gastrostomy (PEG) tube. If an orodispersible tablet is required, lansoprazole orodispersible is the preferred

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choice

Lansoprazole and omeprazole suspensions are available from ‘special-order’ manufacturers. These preparations are unlicensed, very expensive and there are bioavailability differences between suspensions and other oral dose presentations. They should be re-served for patients with narrow bore feeding tubes at risk of block-age. Where a suspension is required, omeprazole 10mg/5ml oral suspension (Quzole powder and diluent for oral suspension) is available at a competitive price from Victoria Pharmaceuticals (ordered via Movianto Northern Ireland) – see ‘specials’ section for further information

Prescribing on an ‘as required’ basis should be considered for patients with intermittent symptoms. Neither lansoprazole or omeprazole are licensed for ‘as required’ use but are frequently used for this indication and there is emerging evidence on the efficacy of on-demand therapy

PPIs should be taken 30 to 60 minutes before food as there is better acid suppression when taken before a meal than without a meal

An interaction between PPIs and clopidogrel leading to reduction of antiplatelet effect has been reported, but the clinical significance is uncertain. If co-prescribing a PPI with clopidogrel is thought necessary, lansoprazole is currently preferred to omeprazole or esomeprazole – see MHRA

Cautions

PPIs might mask the symptoms of gastric cancer. Particular care is required in patients presenting with “alarm features” (add jump to Alarm Features box). In such cases gastric malignancy should be ruled out before treatment

PPIs should be used with caution in the elderly as they are more

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susceptible to adverse effects

There are concerns about the long term treatment with PPIs. The MHRA has issued safety advice on the long term use of PPIs and the following adverse effects:◦ Clostridium difficile infection (see also C. difficile section in

antimicrobial chapter)◦ Hypomagnesaemia (MHRA link)◦ bone fracture (MHRA link)

Subacute cutaneous lupus erythematosus has been reported with PPIs (MHRA link)

Both lansoprazole and omeprazole interact with warfarin. Caution is required with concomitant use

1.3.5a H.pylori eradication

1st choice

for 7 days

No penicillin allergy:

Omeprazole 20mg twice daily or lansoprazole 30mg twice daily + amoxicillin 1g twice daily + clarithromycin 500mg twice daily

Or

Omeprazole 20mg twice daily or lansoprazole 30mg twice daily + amoxicillin 1g twice daily + metronidazole 400mg twice daily

Penicillin allergy:

Omeprazole 20mg twice daily or lansoprazole 30mg twice daily +metronidazole 400mg twice daily+ clarithromycin 250mg twice daily

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2nd choice Refer to Public Health England guidance:

Test and treat for Helicobacter pylori in dyspepsia

Prescribing Notes:

Eradication of H. pylori reduces recurrence of gastric and duodenal ulcers and the risk of re-bleeding. The presence of H. pylori should be confirmed before starting eradication treatment

Refer to Public Health England guidance: Test and treat for Helicobacter pylori in dyspepsia. Updated 2017 https://www.gov.uk/government/publications/helicobacter-pylori-diagnosis-and-treatment

Stop PPIs 2 weeks before and antibiotics and bismuth 4 weeks before H. pylori breath test or stool antigen test

Eradication rates with one-week regimens that include a PPI and amoxicillin with either metronidazole or clarithromycin have fallen to less than 80% due to increased resistance. Treatment failure may reflect poor compliance or resistance to metronidazole or clarithromycin

Seek advice from a gastroenterologist if eradication of H. pylori is not successful with second line treatment

Symptoms may persist for some weeks. In this event, continue PPI therapy for up to 4 weeks

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1.4 Acute Diarrhoea

1st choice Oral rehydration therapy (Dioralyte®)

Doses:

According to fluid loss, usually 200–400 ml solution after every loose motion. Reconstitute 1 sachet with 200 ml of water

Or

Loperamide capsules 2mg; syrup 1mg/5ml

Acute diarrhoea, 4mg then 2mg after each loose stool for up to five days. Maximum 16mg daily

Chronic diarrhoea, 4-8mg daily in divided doses adjusted to response. Maximum 16mg daily

Prescribing Notes

The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion and resulting dehydration. This is particularly important in infants and in frail and elderly patients

The cause of diarrhoea should be identified before starting symptomatic treatment

Loperamide is preferred to codeine phosphate because it is less likely to produce central side-effects and addiction

There have been reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse (see MHRA for further details). However, specialist GI centres may sometimes recommend doses higher than the licensed maximum to control high output stoma

Antidiarrhoeal drugs should not be given in acute inflammatory bowel disease or pseudomembranous colitis, as they may increase

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the risk of developing toxic megacolon, nor in acute infective diarrhoea with bloody stools

Caution

Faecal impaction can give rise to 'overflow diarrhoea' and must be excluded before antidiarrhoeals are started

Review medicines that can precipitate kidney failure in acute dehydration, e.g. ACE inhibitors, NSAIDs. Considering withholding these medicines in patients who become ill and are unable to maintain adequate fluid intake. See Sick Day rules for further information

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1.5 Chronic Bowel Disorders

Chronic bowel diseases include ulcerative colitis and Crohn’s disease. Aminosalicylates, corticosteroids and drugs that affect the immune response form the basis of drug treatment.

The following guidelines apply:

NICE CG 152 covers Crohn’s disease

NICE CG 166 covers Ulcerative Colitis

Northern Ireland IBD Pathway (add link when available)

Fistulating Crohn's disease

Managing flare-ups in patients who have been diagnosed by a specialist as part of a care plan

1st choice Metronidazole, 400mg tablets, 500mg tablets, metronidazole (as benzoate) 200mg/5 ml suspension

Dose: 10-20mg/kg daily orally in divided doses (usual dose 400-500mg three times daily); usually for 1 month but no longer than 3 months because of concerns about peripheral neuropathy

Or

Ciprofloxacin 500mg tablets, 250mg/5 ml suspension

Dose: 500mg twice daily orally

Prescribing Notes

Patients with flare-ups should generally be referred back to

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secondary care for assessment

Patients who have been diagnosed with fistulating Crohn’s disease by a specialist may sometimes be managed in primary care when they present with flare-ups, provided they have previously responded and this is part of the care plan for the patient

Azathioprine is used as a second-line treatment for fistulating Crohn’s disease and continued for maintenance

Cautions

Tendon damage (including rupture) has been reported rarely in patients receiving quinolones. See BNF for further details

1.5.1 Aminosalicylates

Acute Exacerbation of distal ulcerative colitis (proctitis / proctosigmoiditis)

Rectal Treatment

1st choice Mesalazine enema - 1st choice for distal (rectosigmoid) colitis

Available as:

Doses:

Salofalk® mesalazine rectal foam (14 doses)

or

Mild ulcerative colitis affecting sigmoid colon and rectum, 2 metered applications (mesalazine 2g) into the rectum at bedtime or in 2 divided doses

Pentasa® Mesalazine Enema (1g/100ml)

Pentasa® Mesalazine Enema: One enema (1g/100ml) administered at bedtime

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Or

Mesalazine suppositories 1g

Available as:

Salofalk® 1g suppositories (cost-effective choice)

Dose: Acute mild to moderate ulcerative proctitis, one Salofalk 1g suppository once daily inserted into the rectum

Or

Pentasa® 1g suppositories

Dose: acute attack of proctitis, 1g daily for 2-4 weeks

Oral Treatment

1st choice Oral mesalazine

Available as:

Octasa® M/R tablets 400mg, 800mg

Pentasa® M/R tablets 500mg, 1g; sachets 1g, 2g, 4g

Or

Salofalk (mesalazine m/r) granules, 1.5g, 3g

Doses:

Octasa® M/R tablets 400mg, 800mg: ulcerative colitis, acute attack, 2.4-4.8g once daily or in divided doses (doses over 2.4g daily in divided doses only)

Pentasa® M/R tablets: acute treatment, up to 4g daily once daily or in divided doses

Salofalk m/r granules 1.5-3g once daily, dose preferably taken

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sachets in the morning

2nd choice

Prednisolone tablets 1mg, 5mg

Dose: 30-40mg daily (up to 1mg/kg) for 1 week, reducing by 5mg weekly thereafter according to patient response

Prescribing Notes

Refer to CKS and ECCO for further information on the prescribing of aminosalicylates in ulcerative colitis and Crohn’s disease

Drugs used to maintain or induce remission in inflammatory bowel disease should always be started by a specialist, but they may be continued and monitored by a GP in primary care as per shared care arrangements

For acute attacks, GPs may consider titrating doses according to response whilst awaiting specialist admission

Maintenance rectal therapy is an appropriate treatment strategy for rectal disease. Suppositories are the treatment of choice for patients with inflammation confined to the rectum; enemas should be used for more extensive inflammation

Foam and liquid appear to be equally effective in treating patients with distal ulcerative colitis. Foam enemas are generally preferred because they are easier to administer and retention is more comfortable. However, liquid enemas are more effective for proximal disease as they travel further. Suppositories are usually better tolerated than enemas

Mesalazine enemas are likely to be more effective than steroid enemas. Steroid enemas should be reserved for those patients who do not respond to mesalazine. Please note prednisolone

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foam enemas are very high cost. Predsol® retention enema 20mg/100ml rectal solution is a cost effective option. If a steroid foam is required, Budenofalk® (budesonide) rectal foam is less expensive than prednisolone foam

There is no evidence to show that any one oral preparation of mesalazine is more effective than another; however, the delivery characteristics of oral mesalazine preparations may vary. If it is necessary to switch a patient to a different brand of mesalazine, the patient should be advised to report any changes in symptoms

Patient tolerability can vary between mesalazine products. Therefore it is worth trying a few different products before moving on to prednisolone tablets. See BNF for full range of products

Acute exacerbation of extensive disease requires systemic corticosteroid

Maintenance of remission of ulcerative colitis

Oral Treatment

1st choice Octasa® (mesalazine M/R) tablets 400mg, 800mg

Dose: maintenance of remission of ulcerative colitis and Crohn’s ileo-colitis, 1.2-2.4g once daily or in divided doses

Doses of up to 4.8g Octasa® M/R daily may be required for some patients [unlicensed]

Or

Pentasa® (mesalazine M/R) Tablets 500mg, 1g; Sachets 1g, 2g, 4g

Dose:maintenance, 2g once daily;Doses of up to 4g Pentasa® daily may be required for some patients [unlicensed]

Or Standard dose: 500mg three

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Salofalk (mesalazine m/r) granules 500mg,1g, 1.5g, 3g sachets

times a day

Patients at increased risk of relapse*: 3g given as a single daily dose preferably in the morning

* increased risk of relapse for medical reasons or due to difficulties with adherence to three daily doses

Prescribing Notes

There is no evidence to show that any one oral preparation of mesalazine is more effective than another; however, the delivery characteristics of oral mesalazine preparations may vary. If it is necessary to switch a patient to a different brand of mesalazine, the patient should be advised to report any changes in symptoms

Pentasa® tablets may be dispersed in water without losing the M/R effect. They should not be chewed

Mesalazine has very little benefit in maintaining remission in Crohn’s disease and therefore is not recommended for use in Crohn’s, except for perhaps Crohn’s colitis

Cautions

Aminosalicylates can cause blood disorders; patients should report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise occurring during therapy. A blood count should be performed and the drug stopped immediately if a blood dyscrasia is suspected

Avoid aminosalicylates (mesalazine, olsalazine, sulfasalazine) in patients allergic to aspirin, and those with renal disease

Renal function should be monitored before starting an oral aminosalicylate, at 3 months of treatment, and then annually during

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treatment (more frequently in renal impairment)

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1.5.2 Corticosteroids

1st choice Prednisolone tablets Dose: initially 40mg daily, preferably taken in the morning after breakfast for 1 week, reducing by 5mg every week till stopped. Total course 8 weeks duration

OrBudesonide

Choice of budesonide preparation will depend on where in the GI tract the drug is released / licensed indications. Therefore products should be prescribed by brand

Budesonide 3mg capsules enclosing e/c granules (Budenofalk®)

Dose: mild to moderate Crohn’s disease affecting ileum or ascending colon, 9mg once daily in the morning for up to 8 weeks

Budesonide 3mg capsules enclosing e/c, m/r granules (Entocort®)

Dose: mild to moderate Crohn’s disease affecting ileum or ascending colon, 9mg once daily in the morning for up to 8 weeks

Budesonide 9mg m/r tablet (Cortiment®)

Dose: mild to moderate ulcerative colitis, 9mg once daily in the morning for up to 8 weeks

Prescribing Notes

Refractory or moderate inflammatory bowel disease usually requires adjunctive use of an oral corticosteroid for 8 weeks

Ensure that risk of osteoporosis and fragility fractures is managed appropriately

o Calcium and vitamin D supplementation should be

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recommended for patients taking oral steroids

Patients should be risk assessed and considered for a bisphosphonate. NICE considers current or recent use of high dose oral or high dose systemic glucocorticoids (more than 7.5mg prednisolone or equivalent per day for 3 months or longer) to be a major risk factor for fracture http://www.nice.org.uk/guidance/CG146

Patients with inflammatory bowel disease may have increased gastric transit times and resulting difficulty with absorption. Standard release prednisolone rather than enteric coated prednisolone is preferred in these patients

Modified-release budesonide is associated with fewer adverse effects in patients with Crohn’s disease than prednisolone. However, it appears to be significantly less effective at inducing remission in patients with severe disease and with more extensive colonic involvement

Steroid enemas should be reserved for those patients who do not respond to mesalazine. Please note prednisolone foam enemas are very high cost. Predsol retention enema 20mg/100ml rectal solution is a cost effective option. If a steroid foam is required, Budenofalk® (budesonide) rectal foam is less expensive than prednisolone foam

Steroid-sparing treatment for inflammatory bowel disease

1st choice Azathioprine tablets 25mg, 50mg

Or

Mercaptopurine 50mg tablets, 20mg/ml oral suspension

Dose: 2-2.5mg/kg daily

Dose: 1-1.5mg/kg daily

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Prescribing Notes

Azathioprine or mercaptopurine can be used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid-sparing agent. These drugs require blood monitoring in line with shared care protocols. See Shared Care Guideline on Interface Pharmacy website for further information

Methotrexate may be an option for such patients who cannot tolerate azathioprine or mercaptopurine

Cautions

‘Mercaptopurine’ has a similar name to ‘mercaptamine’. Practices and community pharmacists are encouraged to take steps to minimise the risks associated with this, e.g. when selecting these medicines for prescribing from GP clinical system ‘pick lists’. See Medicines Safety bulletin for further information

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1.6 Laxatives

1st choice Ispaghula husk (Fybogel® sachets)

Dose: 1 sachet in water twice daily preferably after meals

Pack size 30

Multi-flavours

Sugar and gluten free

2nd choice Macrogol Oral Powder, Compound (Laxido®)

1-3 sachets daily in divided doses usually for up to 2 weeks; contents of each sachet dissolved in half a glass (approx. 125ml) of water; maintenance, 1-2 sachets daily

After reconstitution the solution can be kept in a refrigerator but discarded if unused after 6 hours

3rd choice Oral Senna tablets 7.5mg, syrup 7.5mg/5ml

Dose: 2-4 tablets or 10-20ml syrup at night

Faecal Loading / Impaction of Rectum

1st choice Macrogol Oral Powder, Compound (Laxido®)

4 sachets on first days, then increased in steps of 2 sachets daily to max. 8 sachets daily; total daily dose to be drunk within a 6 hour period. After disimpaction, switch to maintenance

After reconstitution the solution can be kept in a refrigerator but discarded if unused after 6 hours.

Contains sodium bicarbonate, sodium chloride

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laxative therapy if required

and potassium chloride

2nd choice Glycerol (glycerin) suppositories 4g

Or

Bisacodyl suppositories 10mg

Or

Sodium citrate enema (Micralax® micro-enema)

Dose: 4g suppository, moistened with water before use, as required

Dose: 10mg suppository in the morning

Dose: one enema (5ml) when required

3rd choice Phosphate enema (Fleet® Ready-to-use Enema)

Dose: one enema (118ml) as required

Prescribing Notes

For further details on the management of constipation see CKS See NICE CG 61 for the management of irritable bowel syndrome

Palliative care patients should be managed differently – refer to Palliative Care section

For uncomplicated constipation, first-line therapy should be dietary modification with increased fibre and fluid intake. Constipating medication should be adjusted

Oral laxatives should be offered if dietary measures are ineffective, or while waiting for them to take effect:

o Initial treatment should be with a bulk forming laxative

o If stools remain hard, an osmotic laxative should be added or switched to

o If stools are soft but the person still finds them difficult to pass or

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complains of inadequate emptying, a stimulant laxative should be added

Ispaghula husk may take several days to act

Preparations that swell in contact with liquid, e.g. ispaghula husk, should always be swallowed with plenty of water to avoid intestinal obstruction. They should not be taken immediately before going to bed

Bulk-forming laxatives are not recommended in opioid-induced constipation

If bulk forming, macrogol and stimulant laxatives are unsuitable, consider at least 30ml daily of lactulose; this may take 48 hours to act. Lactulose should not be prescribed on an ‘as required’ basis

Lactulose is not recommended for patients with Irritable Bowel Syndrome – constipation predominant (IBS-C) as it can exacerbate symptoms such as bloating

For people with IBS-C, see also section 1.2 (add jump)

Prucalopride (Resolor®) is recommended for the treatment of chronic constipation in women for whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months has failed. It should be prescribed only by clinicians experienced in the treatment of chronic constipation. Treatment should be reviewed after 4 weeks and discontinuation considered if no benefit (NICE TA211).

Lubiprostone is 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. Lubiprostone should only be prescribed by a clinician with experience of treating chronic idiopathic constipation. See NICE TA318

In chronic constipation, referral should be arranged if red flags are

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present, treatment is unsuccessful, or if there is faecal incontinence

Caution

Lactulose is not recommended for long-term use in older patients due to the potential for fluid and electrolyte imbalance

Patients with cardiovascular impairment should not take more than 2 sachets of oral macrogol powder, compound in any 1 hour

Phosphate enemas should be administered with caution to patients with renal impairment

In refractory constipation, other causes should be considered, e.g. obstruction of bowel

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1.7 Local Preparations for Anal and Rectal Disorders

Anal and perianal pruritus, soreness and excoriation are best treated by application of bland ointments and suppositories (section 1.7.1). When necessary, topical preparations containing local anaesthetics (section 1.7.1) or corticosteroids (section 1.7.2) are used.

1.7.1 Soothing haemorrhoidal preparations

Encourage self-care with OTC products as appropriate

1st choice Anusol® cream, ointment or suppositories

Doses: Anusol® cream or ointment: apply to the affected area at night, in the morning and after defaecation until the condition is controlled. For internal conditions, use rectal nozzle provided

Anusol® suppositories: insert one suppository at night, in the morning and after defaecation

2nd choice Xyloproct® ointment (contains lidocaine 5%)

Dose: Apply several times daily when necessary; short-term use only (up to 3 weeks treatment)

Prescribing Notes

Topical haemorrhoidal products are widely used and people report some benefits with their use. However, the evidence for their use is lacking but general opinion is that they may provide short-term symptomatic relief

Local anaesthetic ointments can be absorbed through the rectal

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mucosa therefore excessive application should be avoided

Preparations containing local anaesthetics should be used for short periods only (no longer than a few days) since they may cause sensitisation of the anal skin

Patients with pruritus ani (itching around the anal canal)/excoriation should avoid applying creams and ointments where possible (as well as avoiding soaps/baby wipes/excessive scrubbing with toilet paper) as this often causes additional irritation. They should be advised to reduce their caffeine intake, avoid soaps/wipes and clean with water. If this fails they can be prescribed Perinal® spray on a when required basis

1.7.2 Compound haemorrhoidal preparations with corticosteroid

1st choice Anusol-HC® ointment or suppositories

Dose: Apply (or insert one suppository) at night, morning and after defaecation, for up to 7 days

Ointment: 30g tube with rectal nozzle

Suppositories: pack size 12

2nd choice Uniroid HC® ointment or suppositories

Dose: Apply (or insert one suppository) at night, morning and after defaecation, for up to 7 days

Ointment: 30g tube with rectal nozzle

Suppositories: pack size 12

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Prescribing Notes

Anusol HC® or Uniroid HC® can be used to provide symptomatic relief of haemorrhoids, pruritus ani and anal fissures

Compound haemorrhoidal preparations containing corticosteroids are suitable for occasional short-term use after exclusion of infections, such as herpes simplex; prolonged use can cause atrophy of the anal skin

1.7.4 Management of Anal Fissures

1st choice Glyceryl trinitrate 0.4% rectal ointment (Rectogesic®)

Dose: Apply 2.5cm of ointment to anal canal every 12 hours until pain stops. Maximum duration of use 8 weeks

Prescribing Notes

Management of anal fissures requires stool softening by increasing dietary fibre in the form of bran or by using a bulk-forming laxative. However, stool softening is probably of no benefit for chronic anal fissures

Short-term use of local anaesthetic preparations may also help. If these measures are inadequate, the patient should be referred for specialist treatment in hospital. The use of a topical nitrate may be considered

In patients treated with Rectogesic® rectal ointment, the most common treatment-related adverse reaction was dose-related headache which occurred with an incidence of 57%

Before considering surgery, topical diltiazem 2% may be used twice daily [unlicensed product] in patients with chronic anal fissures unresponsive to topical nitrates

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1.9 Drugs Affecting Intestinal Secretions

1.9.4 Pancreatic Exocrine Insufficiency

1st choice Creon® 40000 (providing protease (total) 1600 units, lipase 40000 units, amylase 25000 units)

Dose: Creon® 40000: Initially 1-2 capsules with meals

Prescribing Notes

Creon® should be initiated on specialist advice

Creon® should be taken with food. It can be taken whole or contents mixed with fluid or soft food (then swallowed immediately without chewing). Food should not be excessively hot as this may inactivate the drugs

Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology

High doses of pancreatin can cause perianal irritation

Pancreatin can cause perioral and buccal irritation if retained in the mouth

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