The Scottish Medicines Consortium (SMC) has published advice on the use of esomeprazole 10mg gastro-resistant granules for oral solution (Nexium®) within NHS Scotland.  Following an abbreviated submission, it has been accepted for use within NHS Scotland for treatment of gastro-oesophageal reflux disease (GORD) in children 1 to 11 years old (this oral suspension may also be used by patients having difficulty swallowing dispersed esomeprazole gastro-resistant tablets).  The use of this product for this indication in this age group is restricted to patients in whom licensed doses of a generic proton pump inhibitor have been ineffective.

The drug advice notes that the gastro-resistant granules for oral solution have demonstrated bioequivalence to the tablet and capsule formulations.  Doses of 10mg esomeprazole in children aged 1 to 11 resulted in the same exposure to drug as seen with the 20mg dose in adolescents and adults. There is no evidence of comparative efficacy in this population.

Of note, the SMC has previously accepted this product for use in patients in the 12-17 years age group, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease.