Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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Chapter Links... |
LSCMMG: Inflammatory Bowel Disease: High Cost Drugs Commissioning Pathway |
LSCMMG: Primary Care Constipation Guidelines |
MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review |
NICE CG147: Diverticular disease: diagnosis and management |
NICE CG184 Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management |
NICE CG61: Irritable bowel syndrome in adults: diagnosis and management |
NICE NG1: Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people |
Details... |
01.01 |
Dyspepsia and gastro-oesophageal reflux disease |
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01.01.01 |
Aluminium and magnesium containing antacids |
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Co-magaldrox
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Formulary
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Oral suspension
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01.01.01 |
Simeticine alone |
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Simeticone (activated dimeticone)
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Formulary
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Endoscopy use only
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01.01.01 |
Antacid preparations containing dimeticone or local anaesthetics |
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Antacid with Oxetacaine
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Formulary
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Unlicensed special for treatment of painful swallowing, during/following radiotherapy to the head, neck and chest areas
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01.01.02 |
Compound alginate preparations |
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Sodium alginate, calcium carbonate & sodium bicarbonate Peptac liquid
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Formulary
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Oral suspension
In primary care use the most cost effective alginate preparation. E.g. Peptac liquid. Alginates are considered low priority prescribing, for reflux disease only. Dyspepsia should be treated using self care measures and OTC products.
Consider OTC purchase for some conditions: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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Gaviscon Advance
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Formulary
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Oral suspension Reserved for hospital prescribing or reflux disease where Peptac liquid is not tolerated or ineffective.
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Gaviscon Infant
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Formulary
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Oral powder sachets
For paediatric use only
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Sodium citrate 0.3M
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Formulary
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Oral solution 0.3M Maternity ward use only
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01.02 |
Antispasmodics and other drugs altering gut motility |
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01.02 |
Antimuscarinics |
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Hyoscine Butylbromide (Buscopan®)
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Formulary
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Tablets 10mg
Injection 20mg/1mL
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MHRA: Hyoscine butylbromide (Buscopan) injection: risk of serious adverse effects in patients with underlying cardiac disease
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Glycopyrronium Bromide
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Formulary
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Oral Liquid
Hypersalivation in adults and children with neurological conditions [Non-Parkinson's disease] Use most cost-effective product. Care should be taken when prescribing as different strengths of liquid are available.
For Hypersalivation in adults with Parkinson's Disease, see chapter 4.
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LSCMMG: Glycopyrronium Oral NMR
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01.02 |
Other antispasmodics |
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Mebeverine Hydrochloride (Colofac®)
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Formulary
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Tablets 135mg, MR capsules 200mg
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Alverine Citrate
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Formulary
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Capsules 60mg
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Peppermint Oil
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Formulary
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e/c capsules 0.2mL
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Dicycloverine
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Formulary
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01.02 |
Motility stimulants |
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Domperidone
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Formulary
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Tablets 10mg
Suspension 1mg/ml
Pro-kinetic agent 
To be commenced for this indication by GI and Critical Care specialists only.
Usually, the maximum treatment duration should not exceed one week.
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MHRA: Apomorphine with domperidone: minimising risk of cardiac side effects
MHRA: Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents
MHRA: Domperidone: risks of cardiac side effects
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Erythromycin
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Formulary
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E/C Tablets 250mg
Oral suspension 125mg/5ml, 250mg/5ml
Intravenous infusion 1g
Pro-kinetic agent 
To be commenced for this indication by GI and Critical Care specialists only.
Prescriptions should include a review date.
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MHRA: Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban
MHRA: Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
MHRA: Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions
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Metoclopramide
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Formulary
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Tablets 10mg
Oral solution 5mg/5ml
Pro-kinetic agent 
To be commenced for this indication by GI and Critical Care specialists only.
Metoclopramide can induce acute dystonic reactions, these are more common in the young (especially girls and young women) and the very old.
Prescriptions should include a review date.
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MHRA: Metoclopramide: risk of neurological adverse effects
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01.03 |
Antisecretory drugs and mucosal protectants |
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01.03 |
Helicobacter pylori infection |
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Helicobacter pylori eradication
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Formulary
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The following information should be used in conjunction with NICE CG184
*In January 2024, the MHRA published a Drug Safety Update on fluoroquinolone antibiotics. These must now only be prescribed when other commonly recommended antibiotics are inappropriate. NICE is assessing the impact of this warning on recommendations in this guideline.
All courses are 7 days.
First line (option 1)
First line (option 2)
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PPI BD (Prescribe most cost-effective PPI)
Clarithromycin 500mg BD
Amoxicillin 1g BD
Or
PPI BD (Prescribe most cost-effective PPI)
Metronidazole 400mg BD
Amoxicillin 1g BD |
Penicillin allergic (1st line)
Penicillin allergic (2nd line) |
PPI BD (Prescribe most cost-effective PPI)
Metronidazole 400mg BD
Clarithromycin 500mg BD
PPI BD (Prescribe most cost-effective PPI)
Metronidazole 400mg BD
Levofloxacin 250mg BD* |
Quadruple therapy
(Penicillin allergy + previous exposure to clarithromycin and/or fluoroquinolone)
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PPI BD (Prescribe most cost-effective PPI)
Metronidazole 400mg BD
Bismuth subsalicylate 525mg QDS
Tetracycline 500mg QDS |
Previous exposure to clarithromycin and metronidazole |
PPI BD (Prescribe most cost-effective PPI)
Amoxicillin 1g BD
Tetracycline 500mg QDS OR
Levofloxacin 250mg BD* |
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MHRA: Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate
MHRA: Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects
NICE NG184: Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management
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01.03.01 |
H2-receptor antagonists |
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Famotidine
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Formulary
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Tablets 20mg, 40mg
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Nizatidine
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Formulary
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Capsules 150mg, 300mg
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Cimetidine
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Formulary
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Tablets 200mg, 400mg
For use only when other options have proven ineffective. Not a first line option
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01.03.03 |
Chelates and complexes |
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Bismuth subsalicylate
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Formulary
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Chewable tablet 262.5mg
For H.pylori eradication therapy only (unlicensed indication), as part of a defined course (see section 01.03).
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Sucralfate
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Formulary
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Suspension & Tablets
- Specialist initiation only, by GI consultants or GI surgeons - Recommended for bile acid gastritis - Use for general chronic gastritis should only be as a result of endoscopic findings, following an appropriate trial of PPI or H2 antagonist - Not recommended for the treatment of GORD - Course length should be stipulated prior to primary care taking over prescribing responsibility
for radiation proctitis (unlicensed indication). Suspension may be used as an enema (unlicensed use) or there is a 2g/20ml enema available (unlicensed product).
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01.03.05 |
Proton pump inhibitors (PPIs) |
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Lansoprazole
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Formulary
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Capsules 15mg, 30mg Orodispersible tablets 15mg, 30mg
First line
Orodispersible tablets are for paediatric use and adults with swallowing difficulties only
Patients taking more than 30mg daily of lansoprazole are considered to be on high dose treatment. When reducing doses, please choose the lowest effective dose to control symptoms.
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Omeprazole
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Formulary
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Capsules 10mg, 20mg - Second line Patients taking more than 20mg daily of omeprazole are considered to be on high dose treatment. When reducing doses, please choose the lowest effective dose to control symptoms
Omeprazole (Losec MUPS) Dispersible tablets 10mg - For paediatric use only
Omeprazole oral suspension, 10mg/5ml, 20mg/5ml- For paediatric use only (for children 1 month and above), where dispersible tablets are not suitable
Omperazole IV
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MHRA: Clopidogrel and proton pump inhibitors: interaction—updated advice
Omeprazole for gastro-oesophageal reflux disease (GORD)
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Pantoprazole
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Formulary
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Pantoprazole Tablets 20mg, 40mg - Second line
Pantoprazole IV (Injection 40mg)
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Esomeprazole
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Formulary
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Capsules 20mg, 40mg
Gastro-resistant granules sachets 10mg - for paediatric use only
Injection 40mg
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MHRA: Clopidogrel and proton pump inhibitors: interaction—updated advice
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Naproxen & Esomeprazole Tablets
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Formulary
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01.04 |
Acute diarrhoea |
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First line treatment in acute diarrhoea and gastro-enteritis is prevention or treatment of fluid and electrolyte depletion. For details of oral rehydration preparations see section 9. |
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01.04.02 |
Antimotility drugs |
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Loperamide
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Formulary
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Capsules 2mg
First line
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MHRA: Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse
NICE: Short bowel syndrome
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Codeine
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Formulary
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Tablets 15mg, 30mg Liquid 25mg/5mL
Second line
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Teduglutide (Revestive ®)
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Formulary
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Injection
Short bowel syndrome NHS England commissioned drug
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NICE TA804: Teduglutide for treating short bowel syndrome
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01.05 |
Chronic bowel disorders |
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01.05.01 |
Aminosalicylates |
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Most brands of oral mesalazine are not interchangeable as the delivery characteristics of enteric coated preparations vary, the brand should therefore be specified when prescribing mesalazine tablets. Octasa and Asacol however are very similar and may be used interchangeably. Octasa is the preferred brand |
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Mesalazine (oral)
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Formulary
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Mesalazine products should be prescribed by brand.
First line – Octasa
Second line – Pentasa and Salofalk
First line for swallowing difficulties – Pentasa and Salofalk
Patients prescribed Asacol should be switched to Octasa. Patients who cannot tolerate Octasa may remain on Asacol. (Asacol 400mg MR discontinued)
Patients prescribed Mezavant may remain on this brand.
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Mesalazine (rectal)
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Formulary
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Mesalazine products should be prescribed by brand. Formulary options include: Pentasa liquid enema and suppositories. Salofalk foam enema and suppositories. Octasa suppositories.
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Balsalazide Sodium
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Formulary
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Capsules 750mg
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Sulfasalazine
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Formulary
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Tablets 500mg e/c tablets 500mg Liquid 250mg/5mL
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LSCMMG: Sulfasalazine shared care guideline
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01.05.02 |
Corticosteroids |
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Prednisolone (oral)
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Formulary
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Tablets 1mg, 5mg e/c tablets 2.5mg
First line oral corticosteroid treatment.
25mg tablets are classified as Do Not Prescribe.
There is no evidence that e/c prednisolone reduces the risk of gastrointestinal side effects. Uncoated 5mg tablets should be prescribed first line together with a PPI if necessary.
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MHRA: Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration
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Prednisolone (rectal)
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Formulary
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Foam 20mg/metered application, Retention enema 20mg/100mL, Suppositories 5mg
Prednisolone foam enema and suppositories only to be used if documented non-response on prescription to first line budesonide preparation, otherwise prescription must be challenged.
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Budesonide (Budenofalk®)
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Formulary
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e/c capsules 3mg e/c granules 9mg/sachet Foam enema
First line rectal treatment (foam enema)
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Budesonide (Entocort®)
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Formulary
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Capsules 3mg, Enema
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Budesonide (Kinpeygo®)
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Formulary
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Modified release capsules 4mg (targeted release)
For treating primary IgA nephropathy in accordance with NICE TA937
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NICE TA937: Targeted-release budesonide for treating primary IgA nephropathy
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Budesonide (Cortiment MMX®)
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Formulary
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Tablets, M/R 9 mg
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LSCMMG: Budesonide 9mg MR oral tablets (Cortiment) NMR
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01.05.02 |
Oral |
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Budesonide orodispersible tablets (Jorveza)
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Formulary
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Orodispersible tablets 1mg
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NICE TA708: Budesonide orodispersible tablet for inducing remission of eosinophilic oesophagitis
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01.05.03 |
Drugs affecting the immune response |
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Azathioprine
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Formulary
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Tablets 25mg, 50mg
Inflammatory bowel disease.
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LSCMMG: Azathioprine and Mercaptopurine shared care guideline
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Mercaptopurine
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Formulary
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Tablets 50mg
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LSCMMG: Azathioprine and Mercaptopurine shared care guideline
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Methotrexate
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Formulary
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2.5mg tablets, Prefilled syringes and pens (various strengths)
Crohn's disease. Methotrexate should be prescribed once weekly as a single dose on the same day each week. If oral methotrexate is prescribed only use the 2.5 mg strength.
Methotrexate subcutaneous injection is supplied through a homecare arrangement in ELHT.
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LSCMMG: Methotrexate shared care guideline
MHRA: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
MHRA: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
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Ciclosporin
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Formulary
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Capsule
Severe ulcerative colitis
Specialist initiation only
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LSCMMG: Ciclosporin shared care guideline
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Ciclosporin injection
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Formulary
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Severe ulcerative colitis
Specialist initiation only
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01.05.03 |
Tumor necrosis factor alpha (TNF-a) inhibitors |
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Infliximab
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Formulary
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Intravenous infusion 100mg Pre-filled pen 120 mg solution for injection Pre-filled syringe 120 mg solution for injection
Use in high risk patients for prevention of recurrence or upon recurrence of Crohn's Disease following surgery.
Crohn's disease - NICE TA187
Acute exacerbations of Ulcerative Colitis - NICE TA163
Moderate to severe active ulcerative colitis - NICE TA329
For Treatment of immuno-oncology induced colitis/diarrhoea after failure of steroid treatment see section 08.01.
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NICE TA163: Infliximab for acute exacerbations of ulcerative colitis
NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Adalimumab
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Formulary
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Pre-filled syringe or pen
Crohn's disease - NICE TA187
Ulcerative colitis - NICE TA329
High risk patients for prevention of recurrence or upon recurrence of Crohn's Disease following surgery
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NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Golimumab
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Formulary
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Pre-filled syringe or pen
Moderate to severe active ulcerative colitis
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NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Infliximab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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Adalimumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Adalimumab
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Certolizumab pegol
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Formulary
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Do not prescribed for Crohn's disease or ulcerative colitis
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LSCMMG: Certolizumab Pegol Crohn’s disease
LSCMMG: Certolizumab Pegol Ulcerative Colitis
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Golimumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Golimumab
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01.05.03 |
JAK inhibitors |
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Tofacitinib
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Formulary
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Tablets 5mg, 10mg, MR tablets 11mg
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NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
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Upadacitinib (Rinvoq ®)
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Formulary
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Prolonged release tablets 15mg, 30mg, 45mg
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NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease
NICE TA856: Upadacitinib for treating moderately to severely active ulcerative colitis
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Filgotinib
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Formulary
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Tablet 100mg, 200mg
Moderately to severely active ulcerative colitis
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NICE TA792: Filgotinib for treating moderately to severely active ulcerative colitis
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01.05.03 |
Immunomodulating drugs |
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Etrasimod
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Formulary
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Tablets 2mg
For the treatment of ulcerative colitis in accordance with NICE TA956
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NICE TA956: Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over
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Ozanimod
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Formulary
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Capsules 230microgram, 460microgram, 920 microgram
Moderately to severely active ulcerative colitis
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NICE TA828: Ozanimod for treating moderately to severely active ulcerative colitis
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01.05.03 |
Interleukin inhibitors |
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Mirikizumab
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Formulary
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100mg/ml solution for injection pre-filled pen, 300mg/15ml concentrate for solution for infusion vials
For treatment of moderately to severely active ulcerative colitis
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NICE TA925: Mirikizumab for treating moderately to severely active ulcerative colitis
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Risankizumab (Skyrizi®)
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Formulary

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solution for injection pre-filled syringes, solution for injection pre-filled pen 150mg/mL
Crohn's disease - TA888
Moderately to severely active ulcerative colitis - TA998
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NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease
NICE TA998: Risankizumab for treating moderately to severely active ulcerative colitis
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Ustekinumab
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Formulary
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Concentrate for solution for infusion 130mg
Solution for injection 45mg
Pre-filled syringe 45mg, 90mg
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NICE TA456: Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
NICE TA633: Ustekinumab for treating moderately to severely active ulcerative colitis
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01.05.03 |
Monoclonal antibody, anti-lymphocyte |
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Vedolizumab (Entyvio®)
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Formulary
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intravenous infusion 300mg vial, pre-filled pen 108mg solution for injection, pre-filled syringe 108mg solution for injection
Use in high risk patients for prevention of recurrence or upon recurrance of Crohn's Disease following surgery.
Moderately to severely active Crohn's disease - NICE TA352
Moderately to severely active ulcerative colitis - NICE TA342
For Treatment of immuno-oncology induced colitis/diarrhoea after failure of steroid treatment see section 08.01.
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LSCMMG: Vedolizumab SC NMR
NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis
NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
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Vedolizumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Vedolizumab
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01.06 |
Laxatives |
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01.06.01 |
Bulk-forming laxatives |
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Ispaghula Husk
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Formulary
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Granules 3.5g
Consider OTC purchase for some conditions
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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01.06.02 |
Stimulant laxatives |
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Senna
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Formulary
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Tablets 7.5mg, Liquid 7.5mg/5mL
First line
Consider OTC purchase for some conditions
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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Bisacodyl
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Formulary
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Tablets 5mg
Suppositories 5mg, 10mg
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Docusate Sodium
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Formulary
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Capsules 100mg, Liquid 12.5mg/5ml (paeds), 50mg/5ml (adult)
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Glycerol suppositories (Glycerin)
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Formulary
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Suppositories 1g, 2g, 4g
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Sodium Picosulfate
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Formulary
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Liquid 5mg/5mL
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01.06.03 |
Faecal softeners |
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Arachis Oil (peanut oil)
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Formulary
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Enema 130mL
Contains nuts - contraindicated in patients with hypersensitivity to nuts
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01.06.04 |
Osmotic laxatives |
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Lactulose
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Formulary
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Liquid 3.35g/5mL Consider OTC purchase for some conditions
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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Macrogols
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Formulary
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Powder for oral solution
Prescribe the most cost effective brand
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Phosphates (Rectal) (Fleet® )
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Formulary
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Ready to use enema 133mL
Cleen® [formally Fleet®] Ready-to-use Enema - prescribe by brand
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Sodium Citrate (Micolette Micro-enema®)
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Formulary
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Micro-enema
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01.06.05 |
Bowel cleansing preparations |
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Bowel cleansing solutions are for use only before colonic surgery, colonoscopy, or radiological examination to ensure the bowel is free of solid contents. They are not treatments for constipation. |
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Macrogols (bowel cleansing)
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Formulary
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powder for oral solution
Prescribe by brand. Follow local protocols
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Sodium picosulphate & magnesium citrate sachets
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Formulary
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Follow local protocol
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01.06.06 |
Peripheral opiod-receptor antagonist |
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Naldemedine tosylate (Rizmoic®)
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Formulary
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Tablets 200 micrograms
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LSCMMG: Naldemedine
NICE TA651: Naldemedine for treating opioid-induced constipation
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Naloxegol (Moventig®)
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Formulary
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Tablets 12.5mg, 25mg
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LSCMMG: Naloxegol
NICE TA345: Naloxegol for treating opioid‑induced constipation
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Methylnaltrexone bromide
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Formulary
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NICE TA277: Methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care (terminated appraisal)
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01.06.07 |
Other drugs used in constipation |
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Linaclotide (Constella®)
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Formulary
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Capsules 290 micrograms
Prescribe in line with CG61. If no improvement in symptoms at follow up then discontinue
Green restricted in West Lancashire only
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LSCMMG: Linaclotide
NICE CG61: Irritable bowel syndrome in adults: diagnosis and management
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Prucalopride (Resolor ®)
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Formulary
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Tablets f/c 1mg, 2mg
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LSCMMG: Prucalopride
NICE TA211: Prucalopride for the treatment of chronic constipation in women
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01.07 |
Local preparations for anal and rectal disorders |
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01.07.01 |
Soothing haemorrhoidal preparations |
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Anusol®
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Formulary
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Cream, Ointment, Suppositories
Consider OTC/Self care
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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01.07.02 |
Compound haemorrhoidal preparations with corticosteroids |
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Anusol-HC
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Formulary
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Ointment, benzyl benzoate 1.25%, bismuth oxide 0.875%, bismuth subgallate 2.25%, hydrocortisone acetate 0.25%, Peru balsam 1.875%, zinc oxide 10.75%.
Do not use for longer than 7 days
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Scheriproct (Cincochaine with prednisolone)
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Formulary
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Ointment and suppository
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01.07.03 |
Rectal sclerosants |
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Phenol
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Formulary
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phenol 5% in almond oil. 5-mL amp
Contains nuts - contraindicated in patients with hypersensitivity to nuts
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01.07.04 |
Management of anal fissures |
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Glyceryl Trinitrate 0.4% (Rectogesic®)
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Formulary
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Ointment
First Line
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Diltiazem 2%
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Formulary
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Cream, Ointment
unlicensed
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01.09 |
Drugs affecting intestinal secretions |
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01.09.01 |
Drugs affecting biliary composition and flow |
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Ursodeoxycholic acid
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Formulary
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Tablets 150mg Capsules 250mg Liquid 250mg/5mL
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Elafibranor
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Formulary

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NICE TA1016: Elafibranor for previously treated primary biliary cholangitis
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Obeticholic acid (Ocaliva®)
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Formulary
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Tablets 5mg, 10mg
Specialist use only NHS England Commissioned
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MHRA: Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring
NICE TA443: Obeticholic acid for treating primary biliary cholangitis
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01.09.02 |
Bile acid sequestrants |
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Colestyramine
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Formulary
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Powder,4 g/sachet
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Colesevelam
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Formulary
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Tablets 625mg
Off licence use for intractable diarrhoea secondary to bile salt malabsorption Specialist initiation only by gastroenterology
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LSCMMG: Colesevelam
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01.09.04 |
Pancreatin |
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Pancreatin
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Formulary
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First line: Creon capsules 10 000, 25 000 Second line if Creon not tolerated or unavailable: Nutrizym 22 capsules Swallowing difficulties/enteral tubes: Pancrex V powder Paeds only: Creon micro granules
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National Patient Safety Alert: Shortage of Pancreatic enzyme replacement therapy (PERT) – Additional actions
Pancreatic Enzyme Replacement Therapy (PERT) supply updates letter
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01.10 |
Devices |
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Navina Smart trans-anal irrigation
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Formulary
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Neurogenic bowel dysfunction
non neurogenic bowel dysfunction
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LSCMMG: Navina Smart trans-anal irrigation
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Trans-Anal Irrigation Systems (Peristeen, Qufora®, IryPump®,Aquaflush®)
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Formulary
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Treatment should be initiated and stabilised by specialist service providers for a period of 3 months. Prescribing responsibilities may then be transferred to primary care after the initial 3 month period only where there has been a demonstrable improvement in validated measures of bowel function such as the Cleveland Clinic constipation scoring system, St Mark’s faecal incontinence score or neurogenic bowel dysfunction score.
The Choice of product should be made by an appropriately trained specialist, in conjunction with the patient. Where possible the least invasive device, which meets the patients’ needs should be used in preference. It is recognised that there are differences in the levels of service provision across Lancashire and that use of TAI in non-neurogenic bowel dysfunction may result in a significant increase of use.
Existing primary care services cannot be expected to provide support for this. Therefore, TAI is only supported by the LMMG in the context of an agreed commissioning pathway. Specialist services are expected to retain responsibility for on-going patient follow-up and review (until such time that treatment is stopped).
Please see the link to the NICE technology guidance below. NICE advises the following:
“A number of different transanal irrigation systems, including Peristeen, are available. Clinicians and patients should discuss the options available and may try a number of devices before settling on a preferred system…”
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Scottish Medicines Consortium |
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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Cancer Drugs Fund |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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Status |
Description |

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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |

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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |

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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |

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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |

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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |

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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |

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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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