The USFDA has approved oral hydrocortisone granules for the treatment of adrenocortical insufficiency in the pediatric population . The product is the first, and only oral formulation indicated as replacement therapy in children below 17 years of age suffering from adrenocortical insufficiency and congenital adrenal hyperplasia. About the drug Hydrocortisone is an immediate release corticosteroid formulation available in 0.5, 1, 2 and, 5 mg strength. The approval is based on an uncontrolled, open-label, single-arm clinical study in 18 children suffering from adrenocortical insufficiency.
The USFDA has approved the drug with warning and precautions such as adrenal crisis, Cushing’s syndrome, growth retardation, and several psychiatric, GI, and ophthalmic adverse reactions. The drug is contraindicated in patients having hypersensitivity corticosteroids. Source: US Food And Drug…
