SPL Set ID: dc220e63-f9b2-47ea-b8ed-940902a130bf

Hydrocortisone Tablets USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is sparingly soluble in acetone and in alcohol; slightly soluble in chloroform; practically insoluble in water and in ether. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone tablets USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone USP. Inactive ingredients: colloidal silicon dioxide, copovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and sodium starch glycolate. FDA approved identification test differs from the USP test. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.