1: Gastro-intestinal system Please select a topic: 1.1 Antacids and other drugs for dyspepsia 1.3 Ulcer-healing drugs 1.5 Treatment of chronic diarrhoeas 1.7 Local preparations for anal and rectal disorders 1.2 Antispasmodics and other drugs altering gut motility 1.4 Antidiarrhoel drugs 1.6 Laxatives 1.9 Drugs affecting intestinal secretions Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 1 of 14 Date: 10.1.2013 1.1 Antacids and other drugs for dyspepsia Co-magaldrox 195/220 suspension (Maalox®) Peptac suspension (Compound alginic acid preparation) Gaviscon Dual-Infant Sachets (Compound alginic acid preparation) Infacol (Activated dimethicone) Low sodium Dose - Maaloxl® suspension (magnesium hydroxide 195mg, dried aluminium hydroxide 220mg/5mL): 10-20mL, 20 minutes-1 hour after meals, and at bedtime or when required. - Gaviscon Infant Sachets: see Children’s BNF - Peptac® suspension: 10-20mL after meals and at bedtime. - Infacol®: 0.5-1ml before feeds Prescribing notes Liquid formulations of antacids are more effective than tablets or capsules. Compound alginic preparations are less powerful antacids than co-magaldrox but may be more effective for heartburn. Peptac® is the most cost-effective liquid compound alginic acid preparation. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 2 of 14 Date: 10.1.2013 1.2 Antispasmodics and other drugs altering gut motility Antimuscarinics Hyoscine butylbromide 20mg/ml injection (Buscopan®) Hyoscine butylbromide 10mg tablets (Buscopan®) Other antispasmodics Mebeverine 135mg tablets Mebeverine 50mg/5ml SF liquid Peppermint oil 0.2ml capsules (Mintec®) Peppermint water 100ml Dose - Mebeverine tablets 135mg: 1 tablet 3 times daily preferably 20 minutes before meals. - Hyoscine butylbromide tablets 10mg: see BNF - Peppermint Oil capsules: 1-2 capsules 3 times daily for up to 2-3 months if necessary. Prescribing notes Antispasmodics are of limited benefit but are occasionally used for abdominal cramps. Older Patients - Antispasmodics Older patients are particularly susceptible to the antimuscarinic effects of antispasmodics. Gut motility Domperidone Metoclopramide Erythromycin Dose - Metoclopramide tablets 10mg; oral solution 5mg/5mL: 10mg 3 times daily. - Metoclopramide injection 5mg/mL: by intramuscular or intravenous injection, 10mg 3 times daily. - Domperidone tablets 10mg; suspension 5mg/5mL: for symptoms of functional dyspepsia, 1020mg 3 times daily before meals and at night, for up to 12 weeks. Prescribing notes Metoclopramide can cause extrapyramidal side-effects; it is best avoided if possible in patients under 20 years old. Domperidone does not cross the blood brain barrier and is less likely to cause extrapyramidal side-effects than metoclopramide. Initial treatment should be for 4 weeks, then patients should be re-evaluated and the need for continued treatment re-assessed. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 3 of 14 Date: 10.1.2013 1.3 Ulcer-healing drugs H2-receptor antagonists 1st Choice Ranitidine 150mg tablets Ranitidine 75mg/5ml syrup Ranitidine 50mg/2ml injection 2nd Choice Cimetidine 400mg tablets Cimetidine 200mg/5ml syrup Chelates and complexes Sucralfate 1g tablets Sucralfate 1g/5ml suspension 250ml Tri-potassium dictratobismuthate 120mg tablets (Bismuth subcitrate) Prostaglandin analogues Misoprostol 200 microgram tablets Proton pump inhibitors Omeprazole 10mg and 20mg capsules Omeprazole 40mg injection Lansoprazole 15mg, 30mg fast-tabs, Lansoprazole 15mg, 30mg capsules Restricted Alternatives Omeprazole 10mg and 20mg MUPS tablets (Paediatrics only) Esomeprazole 20mg and 40mg tablets (Restricted to gastroenterologists) Dose - Cimetidine tablets 400mg, syrup 200mg/5ml: usually up to 400mg 4 times daily. - Ranitidine tablets 150mg, syriup 75mg/5ml: usually up to 150mg 4 times daily or 300mg twice daily. - Ranitidine injection: see BNF - Esomeprazole tablets 20mg and 40mg: For gastro-oesophageal reflux disease, usually 40mg daily for 6 weeks then reducing to the minimum dose which controls symptoms. - Omeprazole capsules, MUPS tablets 10mg, 20mg: for H. pylori eradication, 20mg twice daily (with appropriate antibiotic regimen) for 7 days. For gastro-oesophageal reflux disease, usually 20mg daily for 4-6 weeks then reducing to the minimum dose which controls symptoms. - Lansoprazole Fastab® 15mg, 30mg; capsules 15mg, 30mg: for H. pylori eradication, 30mg twice daily (with appropriate antibiotic regimen) for 7 days. For gastro-oesophageal reflux symptoms, usually 30mg daily for 4-6 weeks then reducing to minimum dose which controls symptoms. This may include intermittent courses of 2-4 weeks. - Sucralfate tablets 1g, suspension 1g/5ml: see BNF Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 4 of 14 Date: 10.1.2013 - Tripotassium dicitratobismuthate tablets 120mg: see BNF Prescribing notes Dyspepsia is defined as pain or discomfort centred in the upper abdomen (i.e. in or around the midline). Dyspepsia denotes a symptom and not a disease. It is a short-term problem in the majority of patients. One week’s treatment may be sufficient to determine if dyspepsia will respond and whether it is self-limiting. A diagnosis of gastro-oesophageal reflux disease may be made for patients who describe retrosternal heartburn and/or acid regurgitation. In most patients with gastro-oesophageal reflux disease, adequate symptom control is the principal aim of treatment. A 'step down' approach is encouraged starting with 20mg omeprazole daily for severe symptoms. The dose is then adjusted to maintain symptom control using the lowest dose of the most cost-effective agent (antacid, H2-receptor antagonist or proton pump inhibitor). An 'on demand' regimen is acceptable providing it is effective. Patients with endoscopically proven severe oesophagitis or with reflux-related oesophageal strictures are likely to require long-term therapy using a proton pump inhibitor. Those with endoscopically proven severe oesophagitis may require a minimum dose of omeprazole 20mg daily. Stop proton pump inhibitors and antibiotics 2 weeks before Helicobacter pylori breath test or endoscopy. Symptoms may persist for several weeks. In this event continue H2-receptor antagonist or proton pump inhibitor therapy for a total of 2-4 weeks. For current recommended H.pylori eradication regimens consult BNF. Lansoprazole orodispersible tablets (Zoton FasTab®) should be reserved for patients with swallowing difficulties or who require a proton pump inhibitor via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tube. Omeprazole capsules should be prescribed rather than tablets. Tablets are more expensive formulation with no additional benefits. NSAID-associated ulcers and dyspepsia Dose - Omeprazole capsules, 10mg, 20mg: NSAID-associated ulcers and gastroduodenal erosions, 20mg daily for 4-8 weeks; prophylaxis in patients with history of NSAID-associated ulcers, gastroduodenal lesions, or dyspeptic symptoms who need continued NSAID therapy, 20mg daily. - Lansoprazole orthdispersible tablets 15mg, 30mg, capsules 15mg, 30mg: NSAID-associated benign gastric and duodenal ulcers and relief of symptoms, 15-30mg daily for 4-8 weeks (or for gastric ulcers, until healed); prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and symptoms, 15-30mg daily. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 5 of 14 Date: 10.1.2013 Prescribing notes If NSAID-induced gastro-intestinal bleeding or ulceration occur, the NSAID should ideally be stopped, and omeprazole or lansoprazole prescribed. Patients receiving low dose aspirin who are at risk of NSAID-associated ulcers, should be prescribed a proton pump inhibitor concomitantly instead of replacing aspirin with clopidogrel. Lansoprazole orodispersible tablets (Zoton FasTab®) should be reserved for patients with swallowing difficulties or who require a proton pump inhibitor via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tube. Older Patients - Antidiarrhoeal drugs Proton pump inhibitors should be used with caution in the elderly. There may be an association between PPI use & Clostridium difficile infection and osteoporosis. Careful consideration should be made to the risk benefit ratio. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 6 of 14 Date: 10.1.2013 1.4 Antidiarrhoeal drugs Oral rehydration therapy Dioralyte® sachets Electrolade® sachets Antimotility drugs Codeine phosphate 15mg, 30mg tablets Loperamide 2mg capsules Loperamide 1mg/5ml syrup Dose - Dioralyte® oral powder containing sodium chloride 470mg, potassium chloride 300mg,disodium hydrate citrate 530mg, glucose 3.56g/sachet (natural flavoured): reconstitute one sachet with 200mL of water (freshly boiled and cooled for infants). - Codeine phosphate tablets 15mg, 30mg: 15-60mg 3-4 times daily. - Loperamide capsules 2mg; syrup 1mg/5mL: acute diarrhoea, 4mg then 2mg after each loose stool for up to 5 days. Chronic diarrhoea, 4-8mg daily in divided doses adjusted to response. Max 16mg daily. Prescribing notes First-line treatment for acute diarrhoea is rehydration therapy. Loperamide is preferred to codeine phosphate because it is likely to produce central sideeffects. Antidiarrhoeal drugs should not be given in acute inflammatory bowel disease or pseudomembranous colitis, as they may increase the risk of developing toxic megacolon, nor in acute infective diarrhoea with bloody stools Older Patients - Antidiarrhoeal drugs Older patients with acute or prolonged diarrhoea are particularly likely to require fluid replacement. Faecal impaction can give rise to "overflow diarrhoea" and must be excluded before antidiarrhoeals are started. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 7 of 14 Date: 10.1.2013 1.5 Treatment of chronic diarrhoeas Aminosalicylates Balsalazide 750mg capsules Mesalazine 400mg, 800mg tablets (Asacol®) Mesalazine 250mg, 500mg suppositories(Asacol®) Mesalazine 1g foam enema (Asacol®) Mesalazine 500mg MR tablets (Pentasa®) Mesalazine 1g suppositories (Pentasa®) Mesalazine 1g and 2g M/R sachets (Pentasa®) Mesalazine 1g/100ml retention enema (Pentasa®) Mesalazine 500mg sachets (Salofalk®) Mesalazine 1200mg tablets (Mezavant XL®) Olsalazine 250mg capsules Sulphasalazine 500mg tablets, 500mg EN tablets Sulphasalazine 250mg/5ml suspension Corticosteroids Budesonide 3mg C.R. capsules (Entocort®) Prednisolone rectal foam 20mg/dose (Predfoam®) Prednisolone retention enema 20mg/100ml (Predsol®) Prednisolone tablets – see chapter 6 Prednisolone 5mg suppositories (Predsol®) Cytokine modulators Infliximab (Restricted) Adalimumab (Restricted) Dose - see BNF for doses to use for acute attacks and maintenance. Prescribing notes Specialist advice should be sought if diagnosis is unclear. Steroid enemas may be an option in those patients who have failed on or not tolerated mesalazine suppositories or enemas. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 8 of 14 Date: 10.1.2013 Local therapies using retention enemas will resolve symptoms in most patients who have bloody diarrhoea from ulcerative proctitis, without side-effects. Some systemic absorption of steroid occurs from steroid foam enemas; prolonged use may lead to adrenal suppression and steroid side-effects. If the patient does not respond to local enema therapy, or presents with severe disease, systemic corticosteroids and specialist advice should be considered. Oral aminosalicylates (mesalazine or sulfasalazine) are valuable in maintaining remission and also have a role in the treatment of mild active disease. Acute exacerbation of extensive disease requires systemic corticosteroids. Different formulations of mesalazine have different release characteristics and should not be regarded as interchangeable; the proprietary name should be specified. Pentasa® and Asacol® MR release 5-aminosalicylic acid in the colon and have comparable efficacy. 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. There are case reports of interstitial nephritis with mesalazine Patients previously maintained and stable on sulfasalazine, or another aminosalicylate, should not be changed to Pentasa®. Avoid aminosalicylates (mesalazine, olsalazine, sulfasalazine) in patients allergic to aspirin, and those with renal failure. Pentasa® and Asacol® MR may cause watery diarrhoea and occasionally headaches. Sulfasalazine produces more side-effects, particularly blood dyscrasias, nausea, headaches and liver dysfunction. Azathioprine is used on specialist advice in selected patients with steroid dependent inflammatory bowel disease as a steroid sparing agent. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 9 of 14 Date: 10.1.2013 1.6 Laxatives Please refer to the following local guidance on the use of laxatives: Prescribing Guidance for the Treatment of Constipation in Adults Prescribing Guidance for the Treatment of Constipation in Children 1.6.1 Bulk-forming laxatives Ispaghula husk 3.5g sachets - Not for PRN use, should be taken with plenty of water no later than 6p.m. Dose - Fybogel® (ispaghula husk 3.5g) sachets: 1 sachet in water twice daily preferably after meals. Prescribing notes Ispaghula may take several days to act. 1.6.2 Stimulant laxatives Bisacodyl 5mg, 10mg suppositories Co-danthrusate capsules, suspension - Restrictions apply Docusate sodium 100mg capsules Docusate 50mg/5ml (Adult), 12.5mg/5ml (Paediatric) solution Glycerin 1g (Infant) , 2g (Child) , 4g (Adult) suppositories Senna 7.5mg tablets Senna 7.5mg/5ml syrup Sodium picosulphate 5mg/5ml elixir - Children's Directorate Only Dose - Senna tablets 7.5mg; syrup 7.5mg/5mL: 2-4 tablets or 10-20mL syrup at night. - Glycerol suppositories 4g: 4g suppository, moistened with water before use, as required. - Bisacodyl suppositories 10mg: 10mg suppository in the morning. - Docusate capsules 100mg, oral solution 50mg/5ml, 12.5mg/5ml: Adult, up to 500mg daily in divided doses. Prescribing notes Stimulant laxatives become less effective with long-term use. If rectum is full on examination or there is difficulty in evacuation, consider glycerol or bisacodyl suppositories. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 10 of 14 Date: 10.1.2013 1.6.3 Faecal softeners Arachis oil retention enema Liquid paraffin 150ml Dose - Arachis oil retention enema: to soften impacted faeces, 130ml. - Liquid Paraffin: 10-30ml at night when required. Prescribing notes Enema should be warmed before use. Liquid paraffin is less suitable for prescribing. 1.6.4 Osmotic laxatives Lactulose solution - Not for PRN use. Macrogol compound sachets (Laxido®) Movicol-paediatric sachets Movicol-Half sachets Phosphate enema (Fleet) Sodium citrate microenema (Micolette) Dose - Lactulose: initially 15ml twice daily, adjusted according to patient’s needs. - Movicol sachets: chronic constipation, 1-3 sachets daily for up to 2 weeks; maintenance, 1-2 sachets daily. Faecal impaction, 8 sachets daily for max 3 days. - Movicol Paediatric sachets: see BNF or Medicines for Children. - Phosphate enema: Fleet® 118ml. - Micolette Micro-enema®: 1-2 enemas (5-10mL). Prescribing notes Movicol® is effective in established slow transit constipation on specialist advice. Phosphate enemas for bowel evacuation before abdominal radiological procedures, endoscopy, and surgery. Some patients may require manual disimpaction. Lactulose is not recommended for long-term use in older patients. 1.6.5 Bowel cleansing solutions Klean - Prep oral powder Moviprep sachets Sodium picosulphate sachet (Picolax) Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 11 of 14 Date: 10.1.2013 Prescribing notes Bowel cleansing solutions are for use prior to colonic surgery, colonoscopy, or radiological examination. Bowel cleansing solutions are not treatments for constipation. 1.6.7 5HT4- receptor agonists Prucalopride 1mg & 2mg tablets Dose - Prucalopride tablets 1mg, 2mg: 2mg once daily. Prescribing notes Prucalopride is indicated for chronic constipation in women when other laxatives fail to provide an adequate response. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 12 of 14 Date: 10.1.2013 1.7 Local preparations for anal and rectal disorders 1.7.1 Soothing haemorrhoidal preparations Haemorrhoid Reliefl ointment Anusol suppositories Diltiazem 2% ointment (unlicensed) Glyceryl Trinitrate 0.4% ointment 1.7.2. Compound haemorrhoidal preparations with corticosteroids Anusol-HC rectal ointment Proctofoam HC foam aerosol Anusol-HC suppositories Dose - Anusol-HC® (containing benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone, Peru balsam, zinc oxide) ointment, 30g tube with rectal nozzle; suppositories (pack of 12): apply (or insert 1 suppository) night, morning and after defaecation, for up to 7 days. - Anusol (containing benzyl benzoate, bismuth oxide, bismuth subgallate, Peru balsam, zinc oxide) ointment, 30g tube with rectal nozzle: apply (or insert 1 suppository) at night, morning and after defaecation, for up to 7 days. - Proctofoam HC® foam aerosol (containing hydrocortisone acetate 1%, pramocaine hydrochloride 1%): 1 applicatorful by rectum 2-3 times daily abd after a bowel movement (max 4 times daily), do not use for longer than 7 days. - Glyceryl Trinitrate 0.4% ointment: apply 2.5cm of ointment to anal canal every 12 hours until pain stops; max duration of use 8 weeks. - Diltiazem 2% ointment: use twice a day as directed. Prescribing notes - Anusol-HC® can be used to provide symptomatic relief of haemorrhoids, pruritus ani and anal fissure; it can be bought over-the-counter as Anusol Plus HC®. - Diltiazem 2% cream (Anoheal®) may be prescribed on a named patient basis by specialists to treat anal fissure as an alternative to GTN ointment and surgery. 1.7.3 Rectal sclerosants Oily Phenol 5% injection 5ml ampoules Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 13 of 14 Date: 10.1.2013 1.9 Drugs affecting intestinal secretions 1.9.1 Drugs affecting biliary composition and flow Ursodeoxycholic acid 150mg tablets Ursodeoxycholic acid 250mg capsules Ursodeoxycholic acid 250mg/5ml suspension 1.9.2 Bile acid sequestrants Colestyramine 4g sachets 1.9.4 Pancreatic exocrine insufficiency Creon '10 000','25 000', ’40 000’ capsules Pancrex V Powder 300g Dose - Creon® 10,000 capsules (providing protease 600units, lipase 10,000units, amylase 8000units): initially 1-2 capsules with meals. - Creon® 25,000 capsules (providing protease (total) 1000units, lipase 25,000units, amylase 18,000units): initially 1 capsule with meals. - Pancrex V Powder® (providing per gram protease (total) 1400units, lipase 25,000units, amylase 308,000units ): 0.5 g - 2 g swallowed dry or mixed with a little water or milk before each snack or meal Prescribing notes Creon® should be initiated on specialist advice. Creon® should be taken with food. It can be mixed with food or liquids, but these must not be excessively hot since it is inactivated by heat. Mixtures must be ingested within one hour. Pancreatin can cause perioral and buccal irritation if retained in the mouth. High doses of pancreatin can cause perianal irritation. Creon® is more effective when taken with concomitant PPIs, as pancreatin is inactivated by gastric acid. Red = Hospital use only Green = GP & Hospital use. Drugs not classified as Red, Amber or Amber 2 are classified as Green by default Amber 1 = Drugs with shared care agreement Amber 2 = Initiated by Hospital specialist only Gateshead Health NHS Foundation Trust Drug Formulary Drug & Therapeutics Committee Page 14 of 14 Date: 10.1.2013