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November 23, 2020

New Meds and Tech from PES Drugs and Therapeutics committee

Hydrocortisone Granules (Alkindi Sprinkle)

Prepared by: Takara Stanley, Seth Marks and Kyriakie Sarafoglou

Up to date as of: November 4, 2020

On September 29, 2020, the United States Food and Drug Administration approved hydrocortisone granules for pediatric use in the United States, under the brand name, “Alkindi Sprinkle”. Hydrocortisone granules have regulatory approval in Europe since 2018 for the treatment of children with adrenal insufficiency (including congenital adrenal hyperplasia) and are available in lower doses (0.5mg, 1mg, 2mg, 5mg) than are hydrocortisone tablets. Administration is achieved through twisting off the top of the capsule and either sprinkling granules directly onto the tongue, administering via spoon, or mixing in a spoonful of cold or room temperature soft food. Studies demonstrate good absorption, and equivalent clinical outcomes and dosing compared to hydrocortisone tablets.

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New Meds and Tech-PES DT- (Alkindi)- long version-FINAL

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