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Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Chapter 1 Gastro-intestinal System 1.1 Dyspepsia and gastro-oesophageal reflux disease 1.1.1 Antacids and Simeticone Indications: dyspepsia. Magnesium trisilicate mixture – First Choice - GREEN Co-magaldrox suspension (“Mucogel”) - Second Choice – LOW SODIUM - GREEN Altacite Plus/ Maalox Plus – Palliative Care use AMBER 0 Antacid containing Simeticone Additional prescribing advice: Administer between meals and at bedtime, when symptoms occur; additional doses may be taken up to once an hour. Antacids should preferably be given at least 1 hour before or after other drugs, as they may interfere with absorption. Do not give at the same time as enteric-coated tablets, as premature rupture of the coating may occur. Use antacids, which are low in sodium (co-magaldrox) in patients with cardiac, renal or hepatic disease, and use with caution in renal failure as accumulation of aluminium and magnesium may occur. Aluminium-containing antacids may cause constipation and those containing magnesium may cause diarrhoea - antacids containing both (co-magaldrox) are preferred. If reflux is predominant an alginate-containing antacid may be preferred however antacid content is relatively low and it should not be used for general dyspepsia. Antacid & oxetacaine oral suspension – for radiotherapy patients. RED 1.1.2 Compound alginates and proprietary indigestion preparations Alginate in combination with an antacid increases the viscosity of stomach contents and can protect the oesophageal mucosa and should be reserved for use in patients with symptoms of acid reflux. Peptac suspension – First choice - GREEN Gastrocote Tablets – Second choice – GREEN 1 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Paediatric: Gaviscon Infant Sachets – for reflux - GREEN 1.2 Antispasmodics and other drugs altering gut motility Indications: adjunct in gastro-intestinal disorders characterised by smooth muscle spasm. Mebeverine and peppermint oil may relieve pain in irritable bowel syndrome and diverticular disease. Hyoscine butylbromide injection is useful in reducing spasm in endoscopic or radiological procedures – Hospital Use Only. ANTISPASMODICS Mebeverine – First choice - GREEN Second choices: Peppermint Oil - GREEN N.B. Capsules should not be broken or chewed; irritation of mouth or oesophagus may result Alverine citrate AMBER 0 Hyoscine butylbromide AMBER 0 Injection 20mg in 1ml Tablets 10mg - For symptomatic relief of gastro-intestinal or genito-urinary disorders characterised by smooth muscle spasm and bowel colic only. Glucagon – RED Indications: motility inhibitor in examinations of the gastro-intestinal tract by radiography or endoscopy. 1.3 Antisecretory Drugs and mucosal protectants General Guidelines Urgent specialist referral for endoscopic investigation1 is indicated for patients of any age with dyspepsia when presenting with any of the following: chronic gastrointestinal bleeding, progressive unintentional weight loss, progressive difficulty swallowing, persistent vomiting, iron deficiency anaemia, epigastric mass or suspicious barium meal. The Guideline Development Group considered that ‘urgent’ meant being seen within 2 weeks. 1 2 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Patients >55 years old with new symptoms not responding to simple measures (lifestyle advice, antacids) require endoscopy before further treatment to exclude cancer. Lifestyle Advice Lose weight if overweight Avoid lying down after meals Avoid irritant food (spicy, fatty) Reduce alcohol consumption Eat smaller quantities at meals Avoid late-night eating Stop smoking H.Pylori Eradication Patients with peptic ulceration shown to have infection with H. pylori should be treated with an eradication regime. There are many regimes available, but currently the recommended regime based on eradication rate achieved and patient tolerability is:Lansoprazole 30mg twice daily (or Omeprazole 20mg twice daily) + Amoxicillin 1g twice daily + Clarithromycin 500mg twice daily ALL FOR 1 WEEK NB. If allergic to penicillin: Use Clarithromycin 250mg bd and Metronidazole 400mg bd. H. Pylori eradication is not always successful. If symptoms recur, seek specialist advice. It is not necessary to routinely confirm successful eradication in patients who are no longer symptomatic. However, if confirmation is thought necessary for certain patients who are at high risk in which further ulceration may be life threatening - seek specialist advice. Patients with non-ulcer dyspepsia but who have H. pylori infection there is little evidence that eradication will produce relief of dyspepsia, but the patient may still reasonably want to have the infection eliminated. Duodenal ulcer (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline Erosive duodenitis should be treated as for duodenal ulcer. Gastric ulcer (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline 3 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG All patients with a GASTRIC ULCER should be referred for repeat endoscopy after completion of treatment to ensure complete epithelialisation. H.Pylori - Negative Peptic Ulcer (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline All patients with gastric ulcer need to be sent for a repeat endoscopy. Prevention Of Gastro-Intestinal Complications In Those Taking NSAIDs Prophylaxis with low dose PPI should be considered in patients who are in at least one of the following high risk groups, if they are taking regular NSAID therapy: Age 65 years Previous history of peptic ulcer when taking NSAID Previous history of gastro-intestinal bleeding Taking other medicines that could increase the risk of gastro-intestinal side effects Patients on systemic corticosteroid therapy Co-morbidity Treatment Of Peptic Ulceration Occuring During NSAID Therapy (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline Gastro-Oesophageal Reflux Disease (GORD) (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline Non-Ulcer (Functional) Dyspepsia- dyspepsia with no identifiable cause on investigation. (refer to NICE guidance for treatment algorithm) - http://www.nice.org.uk/nicemedia/pdf/CG017fullguideline Treatment is aimed at symptom relief. Step 1 - Consider alternative diagnosis e.g. gallstones, irritable bowel syndrome Step 2 Lifestyle modification + antacid/alginate (Reserve for patients with symptoms of reflux.) 4 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Step 3 - change to lowest effective dose of PPI. Non-Erosive Duodenitis Treat as for non-ulcer dyspepsia. 1.3.1 H2-RECEPTOR ANTAGONISTS Ranitidine - GREEN 1.3.3 CHELATES AND COMPLEXES Sucralfate – Consultant Initiation AMBER 0 Indications: Stress ulcer prophylaxis in critically ill patients and difficult dyspepsia/bile reflux patients. 1.3.5 PROTON PUMP INHIBITORS All prescriptions for proton pump inhibitors should state the intended duration of treatment to avoid indefinite and unnecessary treatment. Discharge letters should also state intended duration of treatment. Lansoprazole -GREEN Fastabs – for swallowing difficulties Only - green NB. Fastabs can be dispersed in a small amount of water and administered by oral syringe or nasogastric tube. Omeprazole - GREEN Mups – Paediatrics Only - green Injection 40mg – Hospital only RED Major peptic ulcer bleeding (following endoscopic treatment) initial intravenous infusion of omeprazole 80mg over 40-60 minutes then by continuous IV infusion, omeprazole 8mg/hour for 72 hours. See FAQ – intranet – pharmacy, medicines information Esomeprazole - Consultant Initiation AMBER 0 Second line after treatment failure with another PPI 5 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.4 Acute diarrhoea. 1.4.2 Antimotility drugs Indications: adjunct to fluid and electrolyte replacement in acute diarrhoea; adjunct to other therapy in chronic diarrhoea. Loperamide – First choice -GREEN Codeine phosphate – Second choice - GREEN Co-phenotrope – Consultant Initiation AMBER 0 For short bowel syndrome and high output stoma patients. Additional prescribing advice: Mild infective diarrhoea lasting < 24 hours should not be treated with antimotility drugs. Oral rehydration preparations may be given, especially to frail and elderly patients. In other cases, investigate cause (history of travel, antibiotics, other drugs, inflammatory bowel disease; stool microscopy and culture). If there are no contra-indications, antimotility drugs may be used to control symptoms. Refer to Antibiotic Guidelines for treatment of enteric infection and antibiotic-associated Clostridium difficile infection. For high output ileostomy and short bowel syndromes control of water and electrolyte losses requires special attention - seek expert help. Do not use anti-motility drugs where impairment of peristalsis should be avoided e.g. hepatic encephalopathy and severe colitis (risk of dilatation). 1.5 Chronic Bowel Disorders INFLAMMATORY BOWEL DISEASE ALL PATIENTS SHOULD BE ASSESSED BY A CONSULTANT WITH AN INTEREST IN GASTROENTEROLOGY (if diagnosis unclear). 1.5.1 Aminosalicylates Mesalazine – amber 0 Indications: treatment of mild to moderate inflammatory bowel disease and maintenance of remission. Additional prescribing advice: Preparations are suitable for various sites of disease. Octasa or Asacol releases mesalazine in the distal ileum and proximal colon and is therefore best suited to ileo-colonic Crohn’s disease and ulcerative colitis. 6 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Pentasa is licensed for ulcerative colitis Different formulations of mesalazine have different release characteristics and should not be regarded as interchangeable; the proprietary name should be specified. If Mesalazine tablets are prescribed – Octasa brand will be dispensed. For Asacol this will need to be prescribed by brand. Mesalazine enema, foam enemas and suppositories may be used for distal colitis or rectal disease resistant to prednisolone enema or suppositories either instead of or in addition to topical prednisolone. Patients should be told 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. Avoid in renal impairment (nephrotoxic). Balsalazide – Consultant initiation AMBER 0 Sulphasalazine (Sulfasalazine) AMBER 2 Indications: induction and maintenance of remission in ulcerative colitis; active Crohn’s disease. 1.5.2 Corticosteroids Prednisolone – For these indications use Plain tablets - NOT E.C. GREEN Indications: Orally - treatment of severe Crohn’s disease and ulcerative colitis Rectally - treatment of proctitis, distal Crohn’s disease and ulcerative colitis; adjunct to systemic steroids in severe distal disease. NB. enteric-coated form not suitable for use in inflammatory bowel conditions characterised by diarrhoea or a rapid transit time as it could cause symptoms to recur. Budesonide (CR) – Consultant initiation AMBER 0 Hydrocortisone (Colifoam) – AMBER 0 7 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.5.3 Drugs affecting the immune response Should only be used under expert supervision. Azathioprine - AMBER 2 Ciclosporin – unlicensed indication - AMBER 2 Mercaptopurine – unlicensed indication - AMBER 2 Methotrexate – unlicensed indication - AMBER 2 Infliximab - NICE TA187, NICE TA163 – RED, NICE TA 329 RED Adalimumab – NICE TA187 – RED, NICE TA329 RED Golimumab NICETA329 - RED 8 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.6 Laxatives GUIDELINES ON TREATMENT OF CONSTIPATION ACUTE CONSTIPATION Identify and treat cause: Mechanical obstruction (if suspected organise X-ray and surgical referral) Underlying disease Dehydration Immobility Drug therapy (if possible, avoid or reduce dose) Pregnancy Low fibre intake CHRONIC CONSTIPATION Assessment: Treat any underlying cause - underlying disease, dehydration, immobility or drug therapy (if possible, avoid or reduce dose). Increase Dietary fibre intake Add bulk forming agent Add faecal softener Add stimulant laxative Movicol (Specialist advice) PREGNANCY Fybogel, lactulose and glycerin suppositories may be used. ELDERLY Bulking agents are unsuitable for frail or immobile elderly patients. A stimulant laxative (e.g. senna) with or without a faecal softener (e.g. docusate) is most appropriate PATIENTS TAKING OPIOID ANALGESICS Patients prescribed regular opiates for any longer than a few days may become constipated e.g. post-operatively. This can be minimised by attention to diet, mobility and fluid intake, but patients prescribed regular opiates for longer than a few days should be prescribed regular laxatives for the duration of opiate treatment if constipation occurs, providing there are no contra-indications (e.g. intestinal obstruction). This is mandatory in terminally ill patients as soon as they are prescribed continuous, regular opiate therapy (see Palliative Care Guidelines). PALLIATIVE CARE See Palliative Care Guidelines. 9 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.6.1 Bulk-forming laxatives Indications: Chronic constipation where dietary measures are insufficient; management of patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel disease and ulcerative colitis. Ispaghula - GREEN N.B. Preparations that swell on contact with water should be swallowed carefully and should not to be taken immediately before going to bed. Additional prescribing advice: Adequate fluid intake must be maintained to avoid intestinal obstruction Avoid use in intestinal obstruction, colonic atony and faecal impaction as they may compound the condition; use with caution in the elderly. Avoid in patients who have difficulty swallowing. Use with caution in patients with opiate-induced constipation (risk of obstruction). May take several days for full effect (patients should be told this) and are therefore more suitable in patients with normal gut motility and uncomplicated constipation. 1.6.2 Stimulant laxatives Indications: Acute constipation Senna - GREEN Bisacodyl - GREEN N.B Acts in 20-60 minutes Docusate (Dioctyl sodium sulphosuccinate) - GREEN N.B. Acts within 1-2 days. Glycerol suppositories (Glycerin) - GREEN Danthron (Dantron) – Palliative Care Only - GREEN N.B. Rodent studies have indicated a potential carcinogenic risk with danthron. It should only be used for opiate-induced constipation in terminally ill patients. Co-Danthrusate Additional prescribing advice: Avoid in intestinal obstruction Avoid prolonged use, except in elderly and terminally ill patients Acts in 8-12 hours when given orally 10 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.6.3 Faecal softeners Indications: to soften impacted faeces Arachis oil Enema - GREEN 1.6.4 Osmotic laxatives Lactulose – First Choice - GREEN Indications: Chronic constipation, hepatic encephalopathy. N.B. Acts in 48 hours; not suitable for acute constipation Constipation – 10ml bd Hepatic encephalopathy Lactulose - 30-50ml 3 times daily, subsequently adjusted to produce 2-3 soft stools daily. Rifaximin NICE TA 337 – Consultant initiation – AMBER 0 Use only when lactulose NOT working Macrogols (movicol) – Second Choice - GREEN Indications: Chronic constipation. Acute Constipation: Phosphates (rectal) Enema - GREEN Sodium citrate (rectal) micro-enema - GREEN 1.6.5 Bowel cleansing preparations Indications: Bowel preparation before elective colonic surgery, colonoscopy or radiological examination. Oral Powder - Klean-prep, Moviprep, Picolax - GREEN See Hospital Guidelines 11 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.6.7 Other Drugs Used in Constipation Indications: chronic constipation in women when other laxatives fail to provide an adequate response. Prucalopride AMBER 0 Approved in line with NICE guidance TA211. After 4 weeks the patient is reassessed and only continued if there was clear benefit. Prescribing will pass to primary care after evidence of benefit to the patient. Lubiprostone AMBER 0 Approved in line with NICE guidance TA318. If treatment with lubiprostone is not effective after 2 weeks, the person should be re-examined and the benefit of continuing treatment reconsidered. Prescribing will pass to primary care after evidence of benefit to the patient. Indications: Moderate to severe irritable bowel syndrome with constipation Linaclotide AMBER 0 Review treatment if no response after 4 weeks Drug treatment of constipation in children General principles Attention to diet & fluid intake may avoid the need for drugs. Whatever drug regime is employed diet & fluids are still the most important factor in determining long term outcome. The general approach to drug treatment is: Step 1: Soften retained faeces with softener Step 2: Add in stimulant to evacuate softened faeces Step 3: Maintain bowel habit with a combination of softener & stimulant Wherever possible, a licensed medicine should be prescribed. However the informed use of unlicensed medicines or of licensed medicines for unlicensed applications is necessary in paediatric practice. The approach should always be flexible to suit the individual child/family and these guidelines are not rigid. Laxatives generally have a low incidence of side effects and with careful supervision doses can be increased above those given in the BNF. There is no convincing evidence of laxative dependence or diminution of effect with continuing use. Various laxatives in multiple combinations may be used - there is little evidence-based data to support any one laxative combination over the others. Support & frequent and prolonged follow up is essential in the treatment of constipation in childhood & it is important that the family realises that long term drug treatment is very often needed. 25% patients off laxatives within 6m of starting Rx 50% patients off laxatives within 1yr of starting Rx 75% patients off laxatives within 2yr of starting Rx 12 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Disimpaction: First choice: Movicol paediatric plain - GREEN Add a stimulant laxative: Senna, Docusate sodium, Bisacodyl or Sodium picosulfate Substitute a stimulant laxative or add an Osmotic laxative: Lactulose Additional Prescribing Advice Lactulose takes 48hrs for full effect. Teeth should be brushed afterwards. Senna may cause gripes. Onset of action 8-12 hours, initial dose should be low and the recommended dose only to be exceeded on specialist advice. Movicol can be used as single daily doses regularly in severe chronic constipation. It may also be used as an alternative to enema/manual removal for faecal impaction. 1.7 Local preparations for anal and rectal disorders. 1.7.2 Compound haemorrhoidal preparations with corticosteroids Indications: local relief of haemorrhoids. “Anusol” - GREEN Scheriproct - GREEN cinchocaine 5mg and hydrocortisone 5mg Scheriproct is suitable for occasional short-term use after exclusion of infection. NB. Radiotherapy patients may use for 14 days. “Anusol HC” - GREEN Suppositories (with hydrocortisone acetate 10mg) NB. Alternative for patients not benefiting from Scheriproct. Radiotherapy patients may use for 14 days. 1.7.3 Rectal sclerosants Indications: haemorrhoids Oily Phenol injection - RED Oily Phenol injection 5% 5ml 13 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.7.4 Management of Anal Fissures First choice: Glyceryl Trinitrate ointment 0.4% (Rectogesic) – AMBER 0 Second choice: Unlicensed - Diltiazem Cream 2% - RED 1.8 Stoma care. Contact stoma care nurse – Kim Moxham (Extension and bleep 2371) Caution when prescribing enteric coated and slow release preparations, laxatives, antidiarrhoeals, antibiotics, antacids, diuretics, digoxin, analgesics, iron preparations and oral contraceptives. 1.9 Drugs affecting intestinal secretions 1.9.1 Drugs affecting biliary composition and flow Indications: gall stone disease in patients in whom laparoscopic or endoscopic treatment is unsuitable, primary biliary cirrhosis. Ursodeoxycholic acid – Consultant initiation AMBER 0 Additional prescribing advice: Gallstone dissolution therapy should only be initiated on expert advice. Therapy is effective only for cholesterol gallstones and treatment may be required for two years or more. 1.9.2 Bile acid sequestrants Indications: pruritis in liver disease. Colestyramine (“Questran light”) – Consultant initiation AMBER 0 Other drugs should be taken at least 1 hour before or 4 - 6 hours after colestyramine to reduce possible interference with absorption. Sachets 4g (sugar free) Dosage: To relieve pruritis 1-2 sachets daily are usually sufficient. N.B. Administration as a single daily dose makes giving other tablets at a different time easier; however patient tolerance may mean administration in divided doses is preferable. Menthol 1% in aqueous cream AMBER 0 14 Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG 1.9.4 Pancreatin Indications: replacement in cystic fibrosis and following pancreatectomy, total gastrectomy or chronic pancreatitis. Pancreatin AMBER 0 Capsules “Creon” 10,000 and 25,000 N.B. capsules may be swallowed whole, or the contents may be mixed with fluid or soft food and swallowed immediately without chewing Granules “Pancrex” 15