1.3.5 Proton pump inhibitors (PPI)

Paediatric reflux disease guidance including information regarding the use of PPIs in this population can be accessed here.

PPIs should only be used where there is a clear indication. PPIs should be prescribed at the lowest effective dose for the shortest period; the need for long-term treatment should be reviewed periodically. All PPIs are absorbed in the small bowel (including dispersible tablets); where there is gastric outlet obstruction, IV omeprazole should be used.

NHS England (NHSE) has published new prescribing guidance for various common conditions for which over-the-counter (OTC) items should not be routinely prescribed in primary care (quick reference guide). These conditions include indigestion and heartburn.

Many indigestion and heartburn treatments are cheap to buy and are readily available OTC along with advice from pharmacies. Some self-care medicines are available from shops and supermarkets. Please click here for further information, exceptions, and a patient leaflet.

Cautions include:

  • The use of proton pump inhibitors (PPI) and histamine H2 receptor antagonists (H2RAs) has been suggested to be a risk factor for the development of C. difficile-associated disease
  • MHRA Drug Safety Update (December 2014): Proton pump inhibitors in long term use: increased risk of fracture
    • PPIs can increase the risk of fractures (particularly when used at high doses for over a year in the elderly). Patients at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D, and if necessary, receive other preventative therapy
  • PPIs may mask the symptoms of gastric cancer
  • MHRA Drug Safety Update (September 2015): very low risk of subacute lupus erythematosus
    • Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug. Refer to the safety update for advice on management
  • MHRA Drug Safety Update (December 2014): Proton pump inhibitors in long term use: reports of hypomagnesaemia
    • Measurement of serum-magnesium concentrations should be considered before and during prolonged treatment with a PPI, especially when used with other drugs that cause hypomagnesaemia or with digoxin.
  • All acid-blocking medicines may reduce the absorption of vitamin B12 due to hypo- or achlorhydria. Monitoring may be considered in patients with reduced body stores or risk factors for reduced dietary vitamin B12 absorption on long-term therapy.
Omeprazole
  • Capsules 10mg, 20mg (£1.18 = 20mg daily)
  • Dispersible tablets 10mg, 20mg, 40mg for paediatric use (£13.92 = 20mg daily)
  • Oral suspension 10mg/5ml sugar free for paediatric use (£92.17 per bottle – 75mls available for dosing per bottle). See notes 2 and 3 below
  • Powder for solution for infusion 40mg

Indications and Dose

Notes

  1. Omeprazole dispersible tablets are included only for use in paediatric patients: they are licensed for treatment of reflux oesophagitis, and symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease in children over 1 year of age and ≥10kg. Lansoprazole orodispersible tablets are included in the formulary for adults with swallowing difficulties (see lansoprazole entry below)
  2. Omeprazole oral suspension 10mg/5ml sugar free is licensed for use in children over 1 month of age for treatment of reflux oesophagitis, and symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease. The suspension should only be used if the prescribed dose cannot be given using the available strength of dispersible tablets (e.g. dose less than 10mg), or for administration through enteral feeding tubes. The suspension is licensed for administration via nasogastric (NG) tubes or percutaneous endoscopic gastronomy (PEG) tubes (see SPC for instructions). Lansoprazole may be the preferred option for administration via fine bore tubes (see lansoprazole entry below)
  3. Ensure the licensed omeprazole oral suspension is prescribed and not a special liquid/suspension by selecting omeprazole 10mg/5ml oral suspension sugar free. The licensed suspension is available as a powder for oral suspension which provides 75mls for dosing per bottle on reconstitution
Lansoprazole
  • Capsules 15mg, 30mg (£1.41 = 30mg daily)
  • Orodispersible tablets 15mg, 30mg (£5.16 = 30mg daily)

Indications and Dose

Notes

  1. Lansoprazole orodispersible tablets are included in the formulary for adults with swallowing difficulties
  2. Lansoprazole orodispersible tablets are licensed for administration via nasogastric feeding tube. The tablets may be dispersed in a small amount of water and administered via a nasogastric tube or oral syringe. Further instructions are available in the manufacturer's SPC. Contact the hospital pharmacy Medicines Information for information on administration via fine bore tubes. For Medicines Information at Torbay Hospital telephone 01803 655304 (ext. 55304) or e-mail sdhct.medicinesinformation@nhs.net. For Medicines Information at University Hospitals Plymouth telephone 01752 439976 (ext. 39976) or e-mail plh-tr.medicines-information@nhs.net.
Esomeprazole
  • Capsules 20mg, 40mg (£2.44 = 20mg daily)
  • Tablets 20mg, 40mg (£2.74 = 20mg daily)
  • Powder for solution for injection 40mg vial

Notes

  1. Esomeprazole is included as a specialist drug for use in a small number of patients with specific needs e.g. some patients who fail on high doses of omeprazole.
  2. It is intended for initiation by a Gastroenterology Consultant only and should not be initiated within primary care.

 

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