Sugar Free Suspension - 195/220

Brands include: Mucogel® & Maalox®

0.3 Molar Solution - used in obstetrics for prophylaxis of acid aspiration

Simeticone

Limited hospital only use in gastroenterology for use in endoscopy only

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

As colic eventually improves on its own, medical treatment isn’t usually recommended. There are some over-the counter treatments available that could be tried however; there is limited evidence for the effectiveness of these treatments.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

As colic eventually improves on its own, medical treatment isn’t usually recommended. There are some over-the counter treatments available that could be tried however; there is limited evidence for the effectiveness of these treatments.

Sugar Free Suspension^OTC

Use instead of Gaviscon

Oral Powder

N.B. Each half of the dual-sachet is identified as ‘one dose'. To avoid errors prescribe as ‘dual-sachet' with directions in terms of ‘dose'.

Tablets - 10mg

Injection - 20mg/ml

Hyoscine Butylbromide is first choice if injection needed (Hyoscine butylbromide tablets are poorly absorbed)

MHRA Drug Safety Update (Feb 2017): Hyoscine butylbromide (Buscopan) injection: risk of serious adverse effects in patients with underlying cardiac disease

Capsules - 60mg

oral solution 320microgram/ml (Sialanar)

AMBER SPECIALIST RECOMMENDATION

Glycopyrronium bromide 320 microgram/ml has been approved for the treatment of severe sialorrhoea in children and adolescents with chronic neurological disorders. Only licensed glycopyrronium oral solution in chidlren. Tablets are not licensed in children and oral solution is more cost effective than using unlicensed tablets. 

Tablets - 135mg 

Sugar-free liquid - 50mg in 5ml (to be used 2nd line in those unable to swallow tablets)

E/C Capsules - 0.2ml

15mg tablets

Tablets - 10mg

Oral Solution - 5mg/5ml

Injection - 10mg/2ml

*N.B. Unlicensed Indication*

Do not use in people under 20 years

MHRA Drug Safety Update (Aug 2013):  restricted dose and duration

Tablets - 150mg, 300mg 

Oral Solution - 75mg/5ml 

2g/50ml enema

Unlicensed

For radiation proctitis; bowel inflammation following radiotherapy

1g/5ml oral suspension

Indication = bile reflux and stomal ulceration.

AMBER SPECIALIST RECOMMENDATION

RED drug for Short term use post Radio Frequency Ablation (RFA) for Barret's Oesophagus and Endoscopic Mucosal Resection (EMA).

Tablets - 200microgram 

Proton pump inhibitors are usually preferred for the prevention of gastro-intestinal bleeding (better tolerated). Most hospital use of misoprostol is for the induction of labour or termination of pregnancy (unlicensed indications).

Capsules - 15mg, 30mg 

Orodispersible Tablets - 15mg, 30mg 

N.B. The orodispersible tablets should only be used in patients who cannot swallow capsules or tablets and for NG/PEG/PEJ use.

Capsules - 20mg 

Orodispersible tablets (MUPS) - 10mg, 20mg & 40mg 

Dosage form restriction: do NOT use tablets. Avoid 40mg strength capsules (use 2x20mg). Omeprazole orodispersible (MUPs) tablets should only be used in patients who cannot swallow capsules or tablets AND where lansoprazole orodispersible tablets are unsuitable.

40mg IV Infusion
40mg Injection (powder for reconstitution)

Drug protocol: IV Omeprazole loading dose (CDDFT intranet access only)

Drug protocol: Omeprazole continuous infusion protocol for adult inpatients (CDDFT intranet access only)

Product stocked at STHFT can only be given as infusion

72 hour continuous infusion is an unlicensed indication. Only on advice of gastroenterology

40mg injection

40mg tablets

AMBER SPECIALIST INITIATION

Only for use in grade 4 oesophagitis. After failure of full dose PPI

Omeprazole 2 mg/ml, Powder for Oral Suspension

AMBER SPECIALIST INITIATION

Only to be used for children with narrow bore feeding tubes or those requiring a dose <5mg. Lansoprazole fast tabs or omeprazole MUPS should be used in all other patients with swallowing difficulties.

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Capsules - 2mg^OTC 

Syrup - 1mg/5ml 

Loperamide capsules should be used in preference to tablets

Note that oro-dispersible tablets should not be routinely used. They are approved for

• short term use in patients who cannot tolerate plain tablets or capsules
• patients undergoing chemo therapy where capsules or plain tablets have been ineffective
• Patients with dysphagia e.g. upper GI cancer patients

Patients with high output stomas should, wherever possible, use either capsules or plain  tablets.  If needed, capsules can be opened and the contents mixed with a small amount of water, jam or yoghurt. Alternatively, the plain tablets can be crushed and mixed with water or soft food (off label). This is a useful option if individuals are seeing undigested capsules or tablets in their stool or stoma collection bag.

Use of loperamide should be avoided in diarrhoea of infective origin until the infecting organism is known. Inappropriate use, particularly in Clostridium difficile diarrhoea, may result in development of toxic megacolon.

MHRA Drug Safety Alert (Sept 2017): Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse 

Tablets - 15mg, 30mg & 60mg

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Octasa

400mg, 800mg, 1600mg e/c m/r tablets

Pentasa

Tablets - 500mg, 1g

Enema - 1g 

Suppositories - 1g 

1g m/r granules/ sachet - MR Granules / sachet are only to be used in patients with difficulty in swallowing

Salofalk

Tablets - 250mg, 500mg, 1g

Granules/sachet - 500mg, 1g, 1.5g, 3g  - only to be used in patients with difficulty in swallowing

Suppositories - 500mg, 1g

Mezavant XL

Tablets - 1.2g 

Asacol

Tablets - 400mg, 800mg - to be used for existing patients only

Enema - 1g

The delivery mechanisms of oral mesalazine may vary. These preparations should not be considered interchangeable.

Capsules - 750mg 

AMBER SPECIALIST RECOMMENDATION

Tablets, EC Tablets - 500mg 

Suspension - 250mg/5mg

Note: RMOC Shared care guideline in development.

9 mg, prolonged release tablets

Prescribe by brand name

Indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient.

(N.B. budenoside capsules are not licensed for this indication)

8 week course to be provided by secondary care.

CR Capsules - 3mg 

AMBER SPECIALIST RECOMMENDATION

Prescribe by brand name

Indications:

• Crohn's disease - Induction of remission in patients with mild to moderate active Crohn's disease affecting the ileum and/or the ascending colon.
• Microscopic colitis - Induction of remission in patients with active microscopic colitis
• Maintenance of remission in patients with microscopic colitis.

1mg orodispersible tablet

Prescribe by brand name

Treatment of eosinophilic oesophagitis in adults older than 18 years of age.

6 -12 week course to be provided by secondary care.

Approved for use in accordance with the following NICE TAs:

• NICE TA708: Budesonide orodispersible tablet for inducing remission of eosinophilic oesophagitis

Note: NICE TA did not cover maintenance treatment and it currently NOT APPROVED on the formulary for maintenance treatment.

2mg per actuation white foam

Approved as 1st line corticosteroid rectal foam with prednisolone rectal foam as 2nd line.

Tablets - 1mg, 5mg 

Rectal Foam - 20mg (Predfoam Rectal preparation not in use in STEES) 

Retention Enema - 20mg 

Suppositories - 5mg 

Tablets

Not a cost-effective product

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Poor evidence base.

UKMI Q&A: Is there any evidence to support the use of enteric coated (EC)
over uncoated prednisolone tablets?

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

40mg in 0.8ml vials, pre-filled pens & disposable devices

Approved for use in accordance with the following NICE TAs:

• 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

Biosimilars are available – note that indications can differ between different products – prescribe by brand. Consult with individual trust pharmacy department for details of preferred biosimilar brand.

50mg tablets

Shared care guidelines for DMARDs can be found here: 

Durham & Darlington Guidelines

Tees Guidelines

25mg, 50mg and 100mg capsules

Must be prescribed by brand name

Shared care guidelines for DMARDs can be found here: 

Durham & Darlington Guidelines

Tees Guidelines

Initiation of IV ciclosporin must be on advice of Consultant Gastroenterologist

Not approved in accordance with the following NICE TAs:

• NICE TA556: Darvadstrocel for treating complex perianal fistulas in Crohn’s disease

50mg injection (prefilled pen & syringe)

Approved for use in accordance with the following NICE TAs:

• NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy

100mg vials for intravenous infusion (Remicade®, Inflectra® & Remsima®)

120 mg solution for injection in pre-filled syringe or pre-filled pen for subcutaneous injection (Remsima®▼)

Approved for use in accordance with the following NICE TAs:

• 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

Infliximab NICE guidance: NICE TA163, 

NTAG September 2015: The Northern (NHS) Treatment Advisory Group recommends the use of infliximab biosimilars as an option where the originator product (Remicade®) would normally be prescribed.

NTAG June 2020: The Northern (NHS) Treatment Advisory Group recommends Remsima SC® be available as additional treatment option during the COVID-19 pandemic for both licensed and off-label uses as part individual hospital Trust management strategies to reduce hospital day case admissions, and keep immunosuppressed people out of hospital during the COVID-19 pandemic. Remsima SC® could be considered as an option where the patient would otherwise get the intravenous Remsima® formulation of Infliximab. This recommendation is subject to any off-label use of Remsima SC® being considered and approved via individual hospital trust governance processes (including clinical governance) for the use of unlicensed/off-label drugs. It was also agreed that this recommendation would be reviewed after 12 months. In June 2021 NTAG reviewed this recommendation after 12 months as agreed. NTAG agreed at this time to make no changes to the recommendation due to the ongoing COVID-19 pandemic and review the position again in a further six months time

Biosimilars are available – note that indications can differ between different products – prescribe by brand. Consult with individual trust pharmacy department for details of preferred biosimilar brand.

50mg tablets^u  - unlicensed indication

Shared care guidelines for DMARDs can be found here: 

Durham & Darlington Guidelines

Tees Guidelines

2.5mg tablets - unlicensed indication

Shared care guidelines for DMARDs can be found here: 

Durham & Darlington Guidelines

Tees Guidelines

MHRA Drug Safety Update (Sept 2020): Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

MHRA Drug Safety Update (Sept 2020): Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

MHRA Drug Safety Update (Sept 2020): Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

5mg tablets

Commissioner CCGs - adults

Approved for use in accordance with the following NICE TAs:

• NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis

MHRA Drug Safety Update (May 2019): Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing

MHRA Drug Safety Update (Mar 2020): Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections

MHRA Drug Safety Update (Oct 2021): Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies

45 mg solution for injection
90 mg solution for injection
45 mg solution for injection in pre-filled syringe
90 mg solution for injection in pre-filled syringe

Approved for use in accordance with the following NICE TAs:

• 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

300mg vial concentrate for IV infusion

108 mg solution for subcutaneous injection

Approved for use in accordance with the following NICE TAs:

• 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

NICE guidance: NICE TA342, NICE TA352

Sachets^OTC

Tablets - 500mg

Tablets - 7.5mg^OTC

Syrup - 7.5mg/5ml

Capsules - 100mg 

Oral Solution - 50mg/5ml, 12.5mg/5ml 

Micro-enema - 120mg in 10g 

EC Tablets - 5mg ^OTC

Suppositories - 5mg, 10mg ^OTC

Suppositories  - 1g, 2g, 4g  ^OTC

25/200 suspension, 25/200 capsules (25mg Dantron &
200mg Poloxamer ‘188’ per 5ml/capsule)
37.5/500 strong capsules (37.5mg Dantron & 500mg
Poloxamer ‘188’)
75/1,000 strong suspension (75mg Dantron & 1g
Poloxamer ‘188’ in 5ml)

N.B. Co-danthramer and Co-danthrusate are generally restricted to use in the treatment of constipation in terminally ill patients. A combination of Senna and Docusate is normally preferred.

50/60 capsules (50mg Dantron & 60mg Docusate sodium)

N.B. Co-danthramer and Co-danthrusate are generally restricted to use in the treatment of constipation in terminally ill patients. A combination of Senna and Docusate is normally preferred.

Lecicarbon A Suppository contains Sodium hydrogen carbonate 0.500 g, sodium dihydrogen phosphate 0.680 g.

AMBER SPECIALIST INITIATION

2nd/3rd line in spinal injuries after bisacodyl and glycerol rectal have been tried

Single Dose Enemas - 130ml 

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Solution^OTC

Hepatic encephalopathy and Paediatrics only. Initiated by a consultant

Laxido®

Movicol® (including Movicol Half  and Movicol Paediatric Plain)  

Cosmocol®  

Use the product with the lowest acquisition cost.

MHRA Drug Safety Update (April 2021): Polyethylene glycol (PEG) laxatives and starch-based thickeners: potential interactive effect when mixed, leading to an increased risk of aspiration            

Enemas (sodium acid phosphate 12.8g + sodium phosphate
10.24g in 128ml)

5ml micro-enemas (sodium citrate 450mg together with a
surfactant, glycerol & sorbitol)

For use as a laxative bowel preparation prior to clinical procedures such as colonoscopy. To be used instead of Klean Prep.

Formulary known as Fleet phosphate enemas

Dose 1 (mango flavour):
Macrogol (polyethylene glycol) 3350 100g plus electrolytes.
Dose 2 (fruit punch flavour):
Sachet A—macrogol (polyethylene glycol) 3350 40g plus electrolytes;
Sachet B—ascorbic acid 7.54g, sod. ascorbate 48.11g.

For bowel cleansing in adults (>18years of age) prior to any procedure requiring a clean bowel, bowel clesansing prior to Colonoscopy and also for CT Virtual Colonoscopy in those patients who cannot tolerate Moviprep.

For consultant prescribing only.

Film Coated Tablets - 12.5mg &  25mg 

Naloxegol: to be used on the advice of a specialist only in line with NICE TA345.  Naloxegol is recommended, within its marketing authorisation, as an option for treating opioid induced constipation in adults whose constipation has not adequately responded to laxatives. An inadequate response is defined as opioid‑induced constipation symptoms of at least moderate severity in at least 1 of the 4 stool symptom domains (that is, incomplete bowel movement, hard stools, straining or false alarms) while taking at least 1 laxative class for at least 4 days during the prior 2 weeks.

200 micrograms film-coated tablets

AMBER SPECIALIST RECOMMENDATION

Approved for use in accordance with the following NICE TAs:

• NICE TA651: Naldemedine for treating opioid-induced constipation

Naldemedine is recommended, within its marketing authorisation, as an option for treating opioid-induced constipation in adults who have had laxative treatment.

Tablets - 1mg, 2mg 

Prucalopride: approved for use in the symptomatic treatment of chronic constipation in women whom laxatives fail to provide adequate relief. For use in accordance with NICE TA211.

Also approved for use in men for the  symptomatic treatment of chronic constipation in  whom at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months have failed to provide adequate relief and invasive treatment for constipation is being considered.

See algorithm for the management of chronic constipation

CDDFT intranet link

290 microgram capsules

Linaclotide: approved for use in IBS with constipation within licensed indications. It should be recommended by a consultant gastroenterologist or through a specialist constipation clinic. Prescribing should be done by the GP following recommendation and GP should assess symptoms after 4 weeks and stop if not effective.

Ointment ^OTC

Suppositories ^OTC

The County Durham and Tees Valley APC Do Not Prescribe List and Grey List can be accessed online at: https://medicines.necsu.nhs.uk/download/tees-prescribing-grey-list/

Lidocaine 5% Ointment

Ointment

Suppositories

Proctofoam HC Rectal Foam 

Hydrocortisone acetate 1.0% w/w Pramocaine hydrochloride 1.0% w/w

Proctosedyl Ointment 30g -Cinchocaine Hydrochloride (Micro) BP 0.5 %ww, Hydrocortisone (Micro) EP 0.5 %ww

Cinchocaine 0.5% / Prednisolone 0.19% ointment - 30g

Cinchocaine 1mg / Prednisolone hexanoate 1.3mg suppositories

Ointment  

Ointment containing lidocaine 5%, hydrocortisone acetate 0.275%, aluminium acetate 3.5% & zinc oxide 18% Recommended for short-term use only

Ointment - 0.4%  

NICE evidence summary for unlicensed / off-label medicines:

ESUOM7 Chronic anal fissure: 0.2% topical glyceryl trinitrate ointment

Cream - 2% ^u

AMBER SPECIALIST RECOMMENDATION

NICE evidence summary for unlicensed / off-label medicines:

ESUOM3: Chronic anal fissure: 2% topical diltiazem hydrochloride

Only to be used if Glyceryl trinitrate ointment fails

Use the most cost-effective product currently out of cream and ointment.

Ointment - 2% ^u

AMBER SPECIALIST RECOMMENDATION

NICE evidence summary for unlicensed / off-label medicines:

ESUOM3: Chronic anal fissure: 2% topical diltiazem hydrochloride

Only to be used if Glyceryl trinitrate ointment fails

Use the most cost-effective product currently out of cream and ointment.

150mg tablets; 250mg tablets; 500mg tablets; 250mg capsules
250mg in 5ml sugar-free suspension

Note licensed indications may differ between formulations.

5 mg and 10mg film-coated tablets

For treating primary biliary cholangitis as per NICE TA443

MHRA Drug Safety Update (April 2018): 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

Capsules

Approved by NHS England for specialist centre use only (Birmingham Childrens Hospital for paediatrics, Leeds/Royal Free for adults) in accordance with NICE HST17

4g sachets
4g sugar-free sachets

10,000 & 25,000 capsules
(10,000 and 25,000 units lipase activity)

Pancreatin equiv. to 8000 BP units lipase activity, 9000 BP units amylase activity, 430 BP units protease activity

AMBER SPECIALIST INITIATION