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

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 tabs); where there is gastric outlet obstruction, IV omeprazole should be used.

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 inhibitor 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 MHRA advice for management advice.
• MHRA Drug Safety Update (December 2014): Proton pump inhibitors in long term use: reports of hypomagnesaemia
  • There is a risk of hypomagnesaemia with prolonged use of PPIs in patients with pre-existing conditions or receiving concomitant medicines (e.g. diuretics, digoxin) which may predispose them to hypomagnesaemia.
• 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

• Gastro-resistant capsules 10mg, 20mg (£1.67 = 20mg daily)
• Dispersible gastro-resistant tablets 10mg, 20mg, 40mg for paediatric use (£13.92 = 20mg daily)
• Oral suspension sugar free 10mg in 5ml for paediatric use (£124.00 per bottle – 75mls available for dosing per bottle). See notes 2 and 3 below
• Powder for solution for infusion 40mg

Indications and Dose

• Dyspepsia and gastro-oesophageal reflux disease (GORD)
• Eradication of Helicobacter pylori
• Paediatric gastro-oesophageal reflux disease (GORD)

Notes

1. Dispersible gastro-resistant 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 product entry below)
2. Omeprazole oral suspension sugar free 10mg in 5ml 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
3. Ensure the licensed omeprazole suspension is prescribed and not a special liquid/suspension by selecting omeprazole 10mg in 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
4. In patients with major peptic ulcer bleeding (active bleeding or non-bleeding visible vessel) following endoscopic haemostatic therapy:
   1. Initial intravenous infusion of 80mg over 40 – 60 mins followed by continuous intravenous infusion, 8mg/hour for 72 hours (unlicensed indication)
   2. Alternatively 80mg three times a day (unlicensed indication)
   3. Refer also to NICE CG141: Acute Upper Gastrointestinal Bleeding for further guidance

Lansoprazole

• Gastro-resistant capsules 15mg, 30mg (£1.11 = 30mg daily)
• Orodispersible tablets 15mg, 30mg (£4.98 = 30mg daily)

Indications and Dose

• Dyspepsia and gastro-oesophageal reflux disease (GORD)
• Eradication of Helicobacter pylori

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 NDHT telephone 01271 322393 or e-mail ndht.medinfo@nhs.net. For Medicines Information at RD&E hospital telephone 01392 402450 or e-mail rde-tr.MIExeter@nhs.net.