esomeprazole oral suspension (Nexium) Abbreviated

following an abbreviated submission

esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium®): is accepted for restricted use within NHS Scotland.

Indication under review: primarily indicated for treatment of gastro-oesophageal reflux disease in children 1 to 11 years old.
Gastro-oesophageal reflux disease (GORD)

• Treatment of endoscopically proven erosive reflux oesophagitis
• Symptomatic treatment of gastro-oesophageal reflux disease

Oral suspension may also be used by patients having difficulty swallowing dispersed esomeprazole gastro-resistant tablets.

Restricted Advice: the use of esomeprazole for this indication and age group should be restricted to patients in whom licensed doses of a generic proton pump inhibitor have been
ineffective.

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.

The Scottish Medicines Consortium 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.