The US FDA has approved a New Drug Application for hydrocortisone oral solution as a replacement therapy in pediatric patients aged five years and older with adrenocortical insufficiency. This formulation is the only FDA-approved oral solution of hydrocortisone, offering simplified administration and precise dosing. It serves as an alternative for patients who struggle to swallow tablets or require specialized delivery methods, such as those using a gastric tube. However, it is not intended for use in stress-related dose adjustment or during acute events.
Dosage and administration Individualize the dose using the lowest possible dosage Recommended starting replacement dosage: 8 to 10 mg/m2 daily Divide the total daily dose into three doses and administer three times daily. For older patients, the daily dose may be divided by two and given twice daily. Based on the patient’s age and…
