Alkindi® (hydrocortisone granules in capsules for opening) is indicated as replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to less than 18 years old)1. Alkindi was approved through the centralised paediatric use marketing authorisation (PUMA) route in the European Union in 2018.
Alkindi is an immediate-release hydrocortisone preparation that has been specifically designed to meet the dosing needs of paediatric patients with adrenal insufficiency for whom no licensed, child-friendly products exist in Europe. Currently, pharmacists often compound (grind) hydrocortisone tablets to a fine powder and reconstitute it in individual capsules or sachets to achieve the lower doses required for children. This compounding is highly variable and often results in inaccurate dosing2. Alkindi is manufactured using commercially proven technology in four doses: 0.5mg, 1mg, 2mg and 5mg, in order to give maximum flexibility to clinicians in tailoring the treatment to the child. Taste-masking excipients that are acceptable for paediatric use eliminate the bitter taste of hydrocortisone, potentially increasing compliance. Alkindi has a shelf life exceeding two years which is significantly longer than that of existing unlicensed hydrocortisone products.
1. Alkindi Summary of Product Characteristics
2. Neumann et al 2017 Quality of compounded hydrocortisone capsules used in the treatment of children. European Journal of Endocrinology 177, 239–242
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