1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information.

KEY: [UL] Unlicensed Preparation; Drug – first line choice; Drug – hospital only; Drug – Amber (TLS), Drug – Red (TLS), see http://medicinesmanagement.doncasterpct.nhs.uk/

Acknowledgements for the majority of this section that has been from taken from NICE BITES which

summarises prescribing guidance of NICE CG184; 2014

Prescribing Guidance: This guideline covers the management of dyspepsia and GORD in adults (>18 years). It also covers endoscopic surveillance for adults with a diagnosis of Barrett’s oesophagus, but does not include details on management of Barrett’s oesophagus. Definition of terms GORD gastro-oesophageal reflux disease NSAIDs non-steroidal anti-inflammatory drugs GI gastrointestinal PPI proton pump inhibitor H2RA H2 receptor antagonist H. pylori Helicobacter pylori See NICE pathway: dyspepsia and GORD

GORD refers to endoscopically determined oesophagitis or endoscopy-negative reflux disease. Dyspepsia is defined broadly to include people with recurrent epigastric pain, heartburn or acid regurgitation, with or without bloating, nausea or vomiting.

PPIs have been found to be a risk factor for recurrence of Clostridium Difficile. Reduction of unnecessary use may reduce the incidence of infection.

Doncaster & Bassetlaw Medicines Formulary

Section 1.3 Ulcer Healing Drugs

Proton Pump Inhibitors: Lansoprazole 15mg and 30mg Capsules Lansoprazole 15mg and 30mg Dispersible Tablets Omeprazole 10mg and 20mg Capsules Omeprazole 10mg and 20mg Dispersible Tablets Omeprazole 40mg Injection H2 Receptor Antagonists: Ranitidine 150mg Tablets Ranitidine 75mg/5ml Liquid Ranitidine 50mg in 2ml Injection Approved by Drug and Therapeutics Committee: October 2016

Review Date: October 2019

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Prolonged use of PPIs has been associated with case reports of hypomagnesaemia:

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON149774

o Weak evidence suggests that Rabeprazole may be the preferred PPI, where this is a recurrent issue.

There is epidemiological evidence of an increased risk of fracture with long term use of PPIs. Patients at risk of osteoporosis should be treated according to current clinical guidelines to ensure they have an adequate intake of vitamin D and calcium:

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON149775

When prescribing PPIs concomitantly with Clopidogrel,, avoid prescribing omeprazole (and esomeprazole – non-formulary). Lansoprazole is the suggested alternative.

Assessment

Immediately (on the same day) refer people presenting with dyspepsia with significant acute GI bleeding to a specialist.

Review medications for possible causes of dyspepsia e.g. calcium antagonists, nitrates, theophyllines, bisphosphonates, corticosteroids and NSAIDs.

In people needing referral, suspend NSAID use.

Consider the possibility of cardiac or biliary disease as part of the differential diagnosis.

In people who have had a previous endoscopy and do not have any new alarm¤ signs, consider continuing management according to previous endoscopic findings.

Consider referral to a specialist service for people: Of any age with GORD symptoms that are non-responsive to treatment

or unexplained, With suspected GORD who are considering surgery, with H. pylori and

persistent symptoms that have not responded to second-line eradication therapy

¤ For more information about alarm signs see Referral guidelines for suspected cancer (NICE CG27) [update in progress;

publication expected May 2015].

Treatment and management common elements of care

Community pharmacists should: Offer initial and on-going help for people with symptoms of dyspepsia.

This includes advice about lifestyle changes, using over-the-counter medication, help with prescribed drugs and when to consult a GP.

Record adverse reactions to treatment and may participate in primary care medication review clinics.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Offer lifestyle advice on healthy eating, weight reduction and smoking cessation.

Advise people to avoid known precipitants associated with their dyspepsia. These include smoking, alcohol, coffee, chocolate, fatty foods and being overweight. Raising the head of the bed and not having a main meal before going to bed may help some people.

Uninvestigated Dyspepsia

Offer H. pylori 'test and treat' to people with dyspepsia.

Leave a 2-week washout period after PPI use before testing for H. pylori with a breath test or a stool antigen test.

Offer full-dose PPI therapy1 for 4 weeks to people with dyspepsia.

If symptoms return after initial treatment, offer a PPI at the lowest dose possible to control symptoms.

Discuss with people how they can manage their own symptoms by using treatment ‘as-needed’.

If there is an inadequate response to a PPI, offer H2RA therapy.

Gastro-Oesophageal Reflux Disease

Manage uninvestigated 'reflux-like' symptoms as uninvestigated dyspepsia.

Offer a full-dose PPI1 for 4 or 8 weeks.

If symptoms return after initial treatment, offer a PPI at the lowest dose possible to control symptoms.

Discuss with people how they can manage their own symptoms by using treatment ‘as-needed’.

If there is an inadequate response to a PPI, offer H2RA therapy.

People who have had dilatation of an oesophageal stricture should remain on long-term full-dose PPI1 therapy

Severe oesophagitis

Offer a full-dose PPI2 for 8 weeks to heal severe oesophagitis.

If initial treatment fails: consider a higher dose of the initial PPI OR switching to another full-dose PPI OR switching to another high-dose PPI2.

For long-term maintenance treatment, offer a full-dose PPI2.

If treatment fails, carry out a clinical review. Consider switching to another PPI at full or high dose2.

Surveillance for people with Barrett's oesophagus – see NICE pathway

Do NOT routinely offer endoscopy to diagnose Barrett's oesophagus, but consider it if the person has GORD. Discuss the person's preferences and risk factors e.g. long duration of symptoms, increased frequency of symptoms, previous oesophagitis, previous hiatus hernia, oesophageal stricture/ulcers, or male gender.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Peptic ulcer disease

For people who have tested positive for H. pylori: offer eradication therapy – see box 1.

For people using NSAIDs: Stop the NSAID if possible, offer full-dose PPI1 or H2RA therapy for 8 weeks and, if H. pylori

is present, subsequently offer eradication therapy.

For people who have tested negative for H. pylori who are not taking NSAIDs: offer full-dose PPI1 or H2RA therapy for 4 to 8 weeks.

For people with gastric ulcer and H. pylori: offer repeat endoscopy 6 to 8 weeks after beginning treatment, depending on the size of the lesion.

For people with peptic ulcer (gastric or duodenal) and H. pylori: offer retesting for H. pylori 6 to 8 weeks after beginning treatment, depending on the size of the lesion.

Re-test for H. pylori using a carbon-13 urea breath test.

For people who continue NSAIDs after a peptic ulcer has healed, discuss the potential harm from NSAIDs and regularly review the need for an NSAID (at least every 6 months). Offer a trial of use on an 'as-needed' basis. Consider reducing the dose, substituting an NSAID with paracetamol, or using an alternative analgesic or low-dose ibuprofen (1.2g daily).

In people at high risk (previous ulceration) and for whom NSAID continuation is necessary, offer gastric protection or consider substitution with a cyclooxygenase-2-selective NSAID. In either case, prescribe with a PPI.

In people with an unhealed ulcer, exclude non-adherence, malignancy, failure to detect H. pylori, inadvertent NSAID use, other ulcer-inducing medication and rare causes such as Zollinger-Ellison syndrome or Crohn's disease.

If symptoms return after initial treatment, offer a PPI to be taken at the lowest dose possible to control symptoms. Discuss with people how they can manage their own symptoms by using treatment ‘as-needed’.

If there is an inadequate response to a PPI: offer H2RA therapy.

Functional dyspepsia

Manage endoscopically determined functional dyspepsia using initial treatment for H. pylori if present, followed by symptomatic management and periodic monitoring.

Offer eradication therapy to people testing positive for H. pylori – see H. pylori eradication treatment.

Do NOT routinely offer re-testing after eradication, although the information it provides may be valued by individual people.

If H. pylori has been excluded and symptoms persist, offer either a low-dose PPI1 or an H2RA for 4 weeks.

If symptoms continue or recur after initial treatment offer a PPI or H2RA to be taken at the lowest dose possible to control symptoms.

Discuss with people how they can manage their own symptoms by using treatment ‘as-needed’.

Helicobacter pylori infection – Testing

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Test for H. pylori using a carbon-13 urea breath test, a stool antigen test, or laboratory-based serology where its performance has been locally validated.

Re-test for H. pylori using a carbon-13 urea breath test.

Do NOT use office-based serological tests for H. pylori because of their inadequate performance

H. pylori eradication treatment§ First-line

Choose a treatment regimen with the lowest acquisition cost and take into account previous exposure to clarithromycin or metronidazole.

Offer people who test positive for H. pylori a 7-day, twice-daily# course of treatment with a (Lansoprazole 30 mg twice daily) PPI3 AND

amoxicillin* 1g twice a day, AND

clarithromycin* 500mg twice a day OR metronidazole* 400 mg twice daily.

People allergic to penicillin: offer a (Lansoprazole 30 mg twice daily) PPI3

AND clarithromycin* 500mg twice a day AND metronidazole 400 mg twice daily.

People who are allergic to penicillin and have had previous exposure to clarithromycin: offer a PPI3 (Lansoprazole 30 mg twice daily), AND

levofloxacin AND tetracycline.

Second-line

People who still have symptoms after first-line treatment: offer a PPI3, AND amoxicillin 1g twice a day, AND

clarithromycin 500mg twice a day OR metronidazole 400 mg twice daily (whichever was not used first-line).

People who have had previous exposure to clarithromycin and metronidazole: offer a PPI3 (Lansoprazole 30 mg twice daily), AND

amoxicillin , AND a quinolone e.g. ciprofloxacinlevofloxacin*, OR tetracycline*.

People who are allergic to penicillin (or who have not had previous exposure to a quinolone): offer a PPI3, AND

metronidazole, AND levofloxacin*.

Seek advice from a gastroenterologist if eradication of H. pylori is not successful with second-line treatment

Laparoscopic fundoplication – see NICE pathway Prescribing

When choosing a PPI, take into account the person's preference and clinical circumstances e.g. tolerability of the initial PPI, underlying health conditions and possible interactions with other drugs, and acquisition cost of the PPI.

Encourage people who need long-term management of dyspepsia symptoms to reduce use of prescribed medication stepwise: by using the lowest effective dose, by trying 'as-needed' use when appropriate, and by returning to self-

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

treatment with antacid and/or alginate therapy (unless there is an underlying condition or co-medication that needs continuing treatment).

Avoid long-term, frequent-dose, continuous antacid therapy as it only relieves symptoms in the short term rather than preventing them.

Advise people that it may be appropriate for them to return to self-treatment with antacid and/or alginate therapy (either prescribed or purchased over-the-counter and taken as needed).

Review Offer people who need long-term management of dyspepsia symptoms an annual review of their condition.

When prescribing a PPI, always ensure that the GP is aware of intended treatment course and if a maintenance dose is required. If a diagnosis is communicated and no course length, then the course length above will be assumed.

Lansoprazole Orodispersible Tablets/Omeprazole Dispersible Tablets:

These preparations should only be used where the dosage form is appropriate.

They can be dissolved in water and given down feeding tubes where the oral route is unavailable please refer to the Handbook of Drug Administration via Enteral Feeding to ensure correct brand is prescribed. For those patients who have a functioning bowel and are able to tolerate sips, the tablets can be allowed to dissolve in the mouth from where it is absorbed enterally. These preparations are not absorbed sublingually or buccally.

H2 Receptor antagonists: H2 receptor antagonists can be useful for maintenance therapy as a step-down from maintenance dose proton pump therapy (either Lansoprazole 15mg or Omeprazole 20mg once daily – see above.) Ranitidine (150mg twice a day or 300mg at night) is the oral H2 receptor antagonist of choice. H2 receptor antagonists at double dose (ranitidine 300mg twice a day) may be useful for treating GORD or oesophagitis in patients intolerant of a PPI.

Stress Ulceration Prophylaxis Ranitidine infusion is used (at a dose of 50mg three times daily) for prophylaxis of gastrointestinal haemorrhage from stress ulceration in critical care situations. The ranitidine prescription should be discontinued on discharge from the critical care environment.

Intravenous PPI therapy (e.g. Omeprazole injection) should only be considered if there is endoscopic evidence of risk of rebleeding in non-variceal gastrointestinal bleeding or in the face of overwhelming life-threatening bleed.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Items for Restricted Prescribing:

Pantoprazole is prescribable only by a member of the ENT team for LPR (laryngopharyngeal reflux) – see guidance below. The formulary choices of PPI for any other acid-related conditions are Lansoprazole and Omeprazole.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Table 1. Doses for dyspepsia, GORD, peptic ulcer disease

Proton pump inhibitor Full/standard dose Low dose (on-demand

dose) Double dose

Lansoprazole 30mg once a day 15mg once a day 30mg twice a day

c

Omeprazole 20mg once a day 10mg once a dayc 40mg once a day

Esomeprazole (not formulary choice)

20mg once a day

a Not available 40mg once a day

b

Pantoprazole (not formulary choice)

40mg once a day 20mg once a day 40mg twice a dayc

Rabeprazole (not formulary choice)

20mg once a day 10mg once a day 20mg twice a dayc

a lower than the licensed starting dose for esomeprazole in GORD, which is 40mg, but considered to be dose-equivalent to other PPIs. In a meta-analysis of dose-related effects, NICE classed esomeprazole 20 mg as a full-dose equivalent to omeprazole 20mg. b 40mg is recommended as a double dose of esomeprazole because the 20mg dose is considered equivalent to omeprazole 20mg. c off-label dose for GORD.

Table 2. Doses for severe oesophagitis

Proton pump inhibitor Full/standard dose Low dose (on-demand

dose) High/double dose

Lansoprazole 30mg once a day 15mg once a day 30mg twice a dayc

Omeprazole 40mg once a dayd 20mg once a day

d 40mg twice a day

d

Esomeprazole (not formulary choice)

40mg once a dayd 20mg

once a day

d 40mg twice a day

d

Pantoprazole (not formulary choice)

40mg once a day 20mg once a day 40mg twice a dayc

Rabeprazole (not formulary choice)

20mg once a day 10mg once a day 20mg twice a dayc

d change from the dose recommendation in 2004, specifically for severe oesophagitis, agreed by the guideline development group during the update of CG17. c off-label dose for GORD.

Table 3. Doses for H. pylori eradication therapy

Proton pump inhibitor Dose

Lansoprazole 30mg twice daily

Omeprazole 20 to 40mg twice daily

Esomeprazole (not formulary choice) 20mg twice daily

Pantoprazole (not formulary choice) 40mg twice daily

Rabeprazole (not formulary choice) 20mg twice daily

Consult Summary of Product Characteristics for full prescribing information.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Laryngopharyngeal Reflux or ‘Silent Reflux’

Laryngopharyngeal Reflux refers to the backflow of food or stomach acid all of the way back up into the larynx (the voice box) or the pharynx (the throat). Symptoms of Laryngopharyngeal Reflux include: (see also ‘Reflux Symptom Score’) Hoarseness A “lump” in the throat (“Globus”) Trouble swallowing Irritable cough Too much mucus in the throat Heartburn Sore Throat The term ‘Silent Reflux’ is used because many patients with LPR never have symptoms of heartburn or indigestion, symptoms traditionally associated with acid reflux. This is because compared to the oesophagus the voice box and throat are much more sensitive to injury and irritation from stomach acid. LPR is most commonly treated by ENT surgeons. This is usually done using a combination of lifestyle advice and acid suppression. Patient lifestyle advice

If you use tobacco, STOP. Smoking makes you reflux. After every cigarette, you have some reflux. Ask about your local Smoking Cessation Clinic.

Take your reflux medication every day as prescribed without fail. Missing even one day can cause further damage to your voice box. Keep taking it until you are told to stop. Get further prescriptions from your GP.

Don’t wear clothing that is too tight, especially around the waist (trousers, corsets, belts).

Bending over can trigger reflux, as can lifting heavy objects or straining due to constipation.

Do not lie down just after eating . . . in fact, do not eat within three hours of bedtime.

Raising the head of your bed can help, as can lying on your left side rather than the right.

You should eat a low-fat diet. Limit your intake of fatty foods and butter. Avoid fried foods, chips, crisps, chocolate, cheese and pastry.

Coffee, citrus juices, and any form of fizzy drink can make things worse. Coca Cola and Pepsi are particularly bad as they are very acidic as well as fizzy.

It is helpful to chew gum containing bicarbonate of soda (sold as “tooth whitening gum”).

If you are overweight, this will contribute, but be warned that extreme physical exercise can also cause reflux.

Alcohol makes reflux worse, so intake should be limited. Spirits and white wine are the worst offenders.

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Optimise treatment before referral GPs should offer lifestyle advice and treat patient with optimum PPI dose and Gaviscon Advance for two months before referring to Secondary Care. The choice of PPI used and course duration should be communicated to the specialist. If this process has not been tried then specialists may assume that the choice of PPI has failed and may offer an alternative PPI choice. Reducing and/or stopping PPI therapy

Most patients do not need to be on long-term PPIs: only a small number need maintenance therapy.

Consider reducing and/or stopping PPI therapy for all patients with LPR taking high dose PPIs for 6 months or more

Do not stop PPIs abruptly. Consider acid rebound. Enter step down therapy at the appropriate level (see schedule below) depending on the current PPI dose

Gaviscon Advance and dietary advice are more suitable long-term measures in the treatment of reflux disease.

Rebound symptoms are common on stopping PPI therapy: Gaviscon Advance, 5 ml three times after meals and 10 ml at night for 2 weeks will help to reduce these.

LPR Treatment

Mild

Offer lifestyle advice

Moderate Severe

Gaviscon Advance

10ml tds + nocte

Lansoprazole 15mg bd

30 minutes before food +

Gaviscon Advance

10ml nocte

Lansoprazole 30mg bd

30 minutes before food

+ Gaviscon Advance

10ml nocte

Re-assess in 2 months

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

PPI dosage reduction schedule (see table of equivalent doses to step down all other PPIs)

Lansoprazole 30 mg bd (half an hour before food)

↓ 2 months

Lansoprazole 15 mg bd (half an hour before food) + Gaviscon Advance

↓ 2 months

Lansoprazole 15 mg od (half an hour before food) + Gaviscon Advance

↓ 2 months

Stop regular Lansoprazole

Consider providing a supply for “prn” use (not licensed dose)

(e.g. before going out for a meal in a restaurant)

Equivalent PPI Doses

Drug

Low Dose

High Dose

Lansoprazole

15 mg

30 mg

Omeprazole

20 mg

40 mg

Rabeprazole (not formulary choice)

10 mg

20 mg

Esomeprazole (not formulary choice)

20 mg

40 mg

Pantoprazole (not formulary choice)

20 mg

40 mg

See also Items for Restricted Prescribing (above)

1see table 1 for PPI doses.

§ some of these recommendations differ to other sources.

2see table 2 for PPI doses.

# all doses of PPI and antibiotics should be given twice daily.

3see table 3 for PPI doses. * see Summary of Product Characteristics for full prescribing information

Prescribing outside this formulary should only take place via a New Product Request

Reflux Symptom Index

Within the past month, how did the following

problems affect you?

0 = No problem

5 = Severe problem

Hoarseness or a problem with your voice 0 1 2 3 4 5

Clearing your throat 0 1 2 3 4 5

Excess throat mucus or feeling of postnasal drip 0 1 2 3 4 5

Difficulty swallowing food, liquids, or tablets 0 1 2 3 4 5

Coughing after eating or lying down 0 1 2 3 4 5

Breathing difficulties or choking episodes 0 1 2 3 4 5

Troublesome or annoying cough 0 1 2 3 4 5

Sensations of something sticking in your throat or a lump in your throat

0 1 2 3 4 5

Heartburn, chest pain, indigestion, or stomach acid coming up

0 1 2 3 4 5

Total