Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
NI Medicines Management Formulary (Adult)BNF Chapter 1 – Gastrointestinal System
NI Medicines Management Formulary
Gastro-intestinal System
(Adult)
1
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
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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
21
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
22
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
23
treatment (more frequently in renal impairment)
24
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
25
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
26
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
27
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
28
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
29
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
30
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
31
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
32
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
33
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
34
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
35