Chapter 1 page number 1 Chapter 1 Gastro-Intestinal System First line drugs Drugs recommended in both primary and secondary care Second line drugs Alternatives (often in specific conditions) in both primary and secondary care Specialist initiated drugs Secondary care,authorised independent prescribers or GPs with special interest initiation. Suitable for continuation by primary care. Shared care agreements may be applicable. Secondary care only drugs Drugs only suitable for secondary care use and initiated by appropriate team or specialist. Primary care prescribers should not be asked to prescribe. Primary & Secondary Notes Care 1.1 Dyspepsia and gastro-oesophageal reflux disease Consider use of simple OTC products initially. Subject to NICE guidance (1). 1.1.1 Antacids and simeticone Magnesium trisilicate 1.1.2 Compound alginates and proprietary indigestion preparations Consider initial use of single OTC products, eg. Rennies. Peptac Secondary care only Simethicone Liquid 40mg/ml (Infacol ) For use ONLY during endoscopic procedures as a defoaming agent. Gastrocote If low sodium preparation required. Gaviscon Infant Prescribe as doses 1 dose = Half a dual sachet. 1.2 Antispasmodics and other drugs altering gut motility Antispasmodics listed all have similar efficacy, but patient response may vary. Atropine and Hyoscine Hydrobromide are not routinely used for gastrointestinal problems. See CNS Chapter 4, and Palliative Care section. Mebeverine MR preparation available. Peppermint Water hydrochloride - For Gynaecology use only. Peppermint oil (Mintec ) Alverine Citrate (Spasmonal ) Sodium Citrate - For use in gynaecology for prophylaxis of acid aspiration. Hyoscine butylbromide Please see MHRA Drug Safety Update Feb 17 for further information and advice on risk of serious adverse effects in patients with cardiac disease.
Chapter 1 page number 2 Motility stimulants Metoclopramide Metoclopramide Domperidone Domperidone For short-term use. Avoid use in patients under 20 years. For long term use (off-label). For short term use. See MHRA Drug Safety Update for information on the risk of serious cardiac side-effects. See Wiltshire Domperidone Guidance for further information and advice. For long term use (off-label). See MHRA Drug Safety Update for information on the risk of serious cardiac side-effects. See Wiltshire Domperidone Guidance for further information and advice. 1.3 Ulcer-healing drugs Helicobacter pylori eradication Patients with proven ulcers should continue treatment with Omeprazole until H pylori eradication is confirmed. Combination products are no longer available. For duration of 1 2 weeks: Omeprazole 20mg twice a day. + Amoxicillin 500mg three times a day. + Metronidazole 400mg three times a day. Omeprazole + Ttripotassium dicitratobismuthate + Tetracycline + Metronidazole For duration of 2 weeks: 20mg twice a day. 120mg four times a day. 500mg four times a day. 400mg three times a day. Penicillin allergic patients Omeprazole + Clarithromycin + Metronidazole For duration of 1 2 weeks: 20mg twice daily. 250mg twice daily. 400mg twice daily. 1.3.1 H 2 receptor antagonists Ranitidine 1 st line Ranitidine IV Cimetidine 2 nd Line 1.3.3 Chelates and Complexes These preparations are rarely indicated and therefore not included within the formulary. 1.3.4 Prostaglandin analogues Misoprostol is not routinely used for gastrointestinal problems. See Obstetrics and Gynaecology Chapter 7.
Chapter 1 page number 3 1.3.5 Proton pump inhibitors (PPIs) The use of PPIs and the treatment of dyspepsia and acid suppression is covered by NICE guidance (1). Treatment of GORD should follow a step up or step down approach with maintenance being at the lowest step in the pathway which controls symptoms. Regular review is essential, length of treatment required must be clearly stated on hospital prescriptions. PPI choices have been made on grounds of cost effectiveness as per NICE guidance (1). It is reasonable to switch patients to Omeprazole therapy if considered appropriate after review. Where formulary PPIs prove unsuitable, in specific circumstances or on the advice of the consultant gastroenterologists alternative PPIs may be considered. Injectable PPIs should be used for patients with frank haematemesis and/or brisk melaena who are haemodynamically unstable. See hospital guidelines on use of IV PPI s and prescription for high dose IV omeprazole. See Acute Trust Guidelines for Immediate management of major GI bleeding. For patients on oral PPIs who are nil by mouth consider IV Ranitidine, Lansoprazole oro-dispersible tablets or Esomeprazole via NG/PEG tube. Clopidogrel and PPI's drug interaction - see MHRA Drug Safety Update Vol2 Issue12 July 2009. Prolonged use of proton pump inhibitors (PPIs) has been associated with hypomagnesaemia. Consider checking magnesium levels before starting PPI treatment and repeat Mg2+ levels periodically during prolonged treatment, especially in patients taking digoxin or drugs that may cause hypomagnesaemia (eg, diuretics) concomitantly. See MHRA Drug Safety Update for further information. See also 3Ts Chapter 9.5.1.3 Magnesium for information and advice on treatment of hypomagnesaemia. Recent epidemiological evidence suggests an increased risk of fracture with long-term use of PPIs. Patients at risk of osteoporosis should be treated in line with current clinical guidelines to ensure they have an adequate intake of calcium and vitamin D. See MHRA Drug Safety Update for further information. See MHRA Drug Safety Update (Sept 2015) for further information on risk of sub-acute cutaneous lupus erythematous with PPIs. For further information, please see Wiltshire Proton Pump Inhibitor (PPI) Guidance. Omeprazole capsules Lansoprazole capsules Omeprazole Injection Use only in line with hospital IV PPI guidelines. Lansoprazole orodispersible tablets Esomeprazole gastroresistant tablets For use in patients with swallowing difficulties. ONLY for use in patients with swallowing difficulties or NG/PEG tube in-situ. Tablet may be dispersed in non-carbonated water and the resultant suspension swallowed or flushed down a gastric tube immendiately (licensed indication). Please note esomeprazole is considerably more expensive than other formulary PPIs. 1.4 Acute diarrhoea 1.4.2 Antimotility drugs
Chapter 1 page number 4 Loperamide See MHRA Drug Safety Update Sept 17 for further information & advice on risk of serious cardiac adverse reactions with high doses seen in abuse / misuse. Codeine Phosphate Eluxadoline For the treamtent of patients with irritable bowel syndrome with diarrhoea in line with NICE TA471. See 3Ts IBS-D Pathway for Adults for further information on place in therapy. See MHRA Drug Safety Update Dec 17 for further information and advice on risk of pancreatitis. 1.5 Chronic bowel disorders For the management of antibiotic associated colitis, see Chapter 5 Infections. Preparations should be prescribed by brand as they vary in bioavailability and release profiles. The choice of drug should be determined by the distribution of the patient s inflammatory bowel disease, in consultation with the specialist if required. Aminosalicylates Patients should be advised to report any unexplained signs of bleeding or infection e.g. sore throats or fever. If these occur, the drug should be stopped and a full blood count performed see BNF section 1.5 (3). Oral preparations Mesalazine (Salofalk ) First-line Mesalazine (Octasa ) Mesalazine (Asacol ) Mesalazine (Pentasa ) Second-line ONLY for existing patients and ONLY where switching to Octasa has not been possible. Third-line Sulfasalazine (Salazopyrin EN ) Balsalazide Rectal Preparations Mesalazine (Asacol ) Mesalazine (Pentasa ) Mesalazine (Salofalk ) Treatment of acute ulcerative colitis and Crohn s disease
Chapter 1 page number 5 Ciclosporin Azathioprine (Imuran ) Methotrexate Mercaptopurine Unlicensed use in ulcerative colitis. Unlicensed use in ulcerative colitis, Crohns Disease and inflammatory bowel disease. Please refer to Azathioprine & Mercaptopurine SCA. For Crohns Disease. Unlicensed use in inflammatory bowel disease. Unlicensed use in inflammatory bowel disease. Please refer to Azathioprine & Mercaptopurine SCA. Infliximab See NICE TA187 and NICE TA163. See MHRA Drug Safety Update for information on risk of TB or reactivation of latent TB. Adalimumab (Humira ) See NICE TA187. See MHRA Drug Safety Update for information on risk of TB or reactivation of latent TB. Vedolizumab (Entyvio ) For treatment of moderate to severely active ulcerative colitis in accordance with NICE TA342. For treatment of moderate to severely active Crohn s Disease in accordance with NICE TA352. Ustekinumab For treatment of moderate to severely active Crohn s Disease in accordance with NICE TA 456. Corticosteroids Please see MHRA Drug Safety Update Aug 2017 for information and advice on the rare risk of central serous chorioretinopathy with local and systemic administration of corticosteroids. Prednisolone tablets 1mg, 5mg & 25mg Non EC tablets should be prescribed. Please note plain prednisolone tablets 5mg may be crushed and dispersed in water and administered orally or via NG/PEG tube (off-label). For chronic use, prescribe minimum effective dose. Monitor for osteoporosis. Hydrocortisone injection Available within 24 hours in the Acute Trust. Prednisolone oral solution 1mg/ml Prednisolone soluble tablets 5mg Budesonide capsules ONLY for use in patients unable to tolerate plain prednisolone tablets 5mg. Please note oral solution 1mg/ml is more expensive than plain tablets 5mg. ONLY for use in patients unable to tolerate prednisolone oral solution 1mg/ml. Please note soluble tablets 5mg are considerably more expensive than both plain tablets 5mg and oral solution 1mg/ml. Management of terminal Crohn s disease affecting the ileum. Use as per license - up to 8 weeks.
Chapter 1 page number 6 Rectal Preparations Hydrocortisone acetate 10% rectal foam (Colifoam ) Prednisolone (Predenema ) Prednisolone (Predsol ) Miscellaneous Modulen IBD Only on the advice of a specialist and ONLY in children. 1.6 Laxatives Non- drug interventions should be tried first, including dietary measures. See 3Ts Guidance on Management of Constipation in Adults. Please review all laxative prescriptions prior to discharge from hospital. Use lowest effective dose and avoid long-term use where possible. 1.6.1 Bulk-forming laxatives Drink adequate amounts to avoid intestinal obstruction. Ispaghula husk 1.6.2 Stimulant laxatives Consider use with opioids to avoid faecal overload and obstruction that may occur with other laxatives. Usually taken at bedtime to produce an effect next morning. Senna Usually taken at bedtime. Bisacodyl Docusate sodium Glycerol Co-danthrusate 1.6.3 Faecal softeners Docusate sodium Rapid evacuation. Only licensed for use in palliative care. Arachis oil enemas 1.6.4 Osmotic laxatives Encourage good fluid intake. Lactulose takes at least 48 hours to have an effect and is not suitable for rapid relief.
Chapter 1 page number 7 Magnesium Hydroxide Mixture Macrogols (Laxidol /Movicol ) Macrogols (Movicol Paediatric Plain) Lactulose Liquid paraffin and Magnesium hydroxide oral emulsion. Use with caution in the elderly. For adults only. For paediatrics only. For use in adults, pregnancy (short term use only) and paediatrics. Alsofor use in treatment of hepatic encephalopathy. Post- gastrointestinal surgery (short term use only). Phosphates Sodium Citrate Short term use only. (Rectal) 1.6.5 Bowel cleansing solutions Sodium Picosulfate with Magnesium Citrate Citramag Fleet Phospho-soda Moviprep 1.6.7 5HT 4 receptor agonists Klean-Prep
Chapter 1 page number 8 Linaclotide Lubiprostone ONLY for treatment of constipated IBS in line with the Wiltshire Pathway for the Management of Irritable Bowel Syndrome with Constipation in Adults. May be considered as an option for patients with chronic idiopathic constipation who have tried at least 2 different types of laxatives at the highest possible doses for at least 6 months without relief, and for whom invasive treatment is being considered. See NICE TA 318 but please note the MHRA advises lubiprostone is ONLY licensed for use as a 2-week course i.e. prolonged use after 2 weeks is off-label. See 3Ts Guidance on Management of Constipation in Adults. Prucalopride May be considered as an option for women with chronic constipation, who have tried at least 2 different types of laxatives at the highest possible doses for at least 6 months, without relief and in whom clinicians are considering invasive treatment. See 3Ts Guidance on Management of Constipation in Adults. Naloxegol May be considered as an option for treatment of opioidinduced constipation in adults, whose constipation has failed to adequately respond to laxatives appropriately escalated in accordance with 3Ts Guidance on the Management of Constipation in Adults, and in whom stopping opiates would be clinically inappropriate. See NICE TA 345. 1.7 Local preparations for anal and rectal disorders 1.7.1 Soothing haemorrhoidal preparations Anusol 1.7.2 Compound haemorrhoidal preparations with corticosteroids Anusol-HC Scheriproct 1.7.3 Rectal sclerosants 1.7.4 Management of anal fissures Glyceryl trinitrate May prevent need for surgical intervention. ointment 0.4% (Rectogesic ) Oily phenol injection 5% Diltiazem cream/ointment Unlicensed preparation. For prescribing bygwh General Surgeons on hospital outpatient prescription (yellow script) only. 1.8 Stoma care Contact GWH Stoma Nurses via the Switchboard at Great Western Hospital for information on preparations available. See also guidance in the BNF Section 1.8 (3). 1.9 Drugs affecting intestinal secretions 1.9.1 Drugs affecting biliary composition and flow Ursodeoxycholic acid 1.9.2 Bile acid sequestrants Colestyramine sachets For use in treatment of itching associate with bilary obstruction and cirrhosis.
Chapter 1 page number 9 1.9.4 Pancreatin Creon Always specify capsule strength on prescription. 8.3.4.3 Somatostatin analogues Also see Chapter 6 Endocrine. Octreotide See Swindon CCG Somatostatin policy statement. Lanreotide (Somatuline Autogel ) Treatment of acromegaly and Neuroendocrine tumours and carcinoid syndrome. NHS Swindon, NHS Wiltshire and Great Western Hospitals NHS FoundationTrust in collaboration with Avon & Wilts Mental Healthcare Partnership Trust. References 1. Nice Guideline CG17: Managing dyspepsia in adults in primary care. http://www.nice.org.uk/guidance/cg17 2. Nice Guideline TA40: The use of infliximab for Crohn's disease. http://www.nice.org.uk/guidance/ta40 3. BNF http://www.bnf.org/bnf/