The SMC has accepted hydrocortisone granules for restricted use for the replacement therapy of adrenal insufficiency. This acceptance is limited to use in infants and young children aged from birth to less than six years old, where the only options to get the right dose are to break up and crush hydrocortisone tablets, produce special solutions or to use hydrocortisone buccal tablets (that dissolve when held between the gum and the cheek) that are not licensed (approved) for treating adrenal insufficiency.
The SMC have published the explanation for their decision, which is available for download from our website here : Decision explained hydrocortisone final.pdf.
Further details are available here : https://www.scottishmedicines.org.uk/medicines-advice/hydrocortisone-alkindi-fullsub-smc2088/
