Fludrocortisone Acetate is a synthetic corticosteroid with potent mineralocorticoid activity and glucocorticoid activity. Chemically, it is 9-fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate. Its molecular formula is C₂₃H₃₁FO₆ and its molecular weight is 422.49 g/mol. Its CAS Registry Number is 514-36-3.
Fludrocortisone Acetate is primarily used for its mineralocorticoid effects, which include promoting sodium retention and increasing extracellular fluid volume. It is available pharmaceutically as oral tablets, commonly at a strength of 0.1 mg per tablet.
Fludrocortisone Acetate is used primarily for its mineralocorticoid activity. It is incorporated into pharmaceutical products used in conditions requiring mineralocorticoid replacement or supplementation.
Fludrocortisone acts on mineralocorticoid receptors, promoting sodium retention and increasing potassium and hydrogen-ion excretion. Its mineralocorticoid activity is substantially stronger than its glucocorticoid activity.
Fludrocortisone Acetate Tablets USP are available as 0.1 mg scored tablets for oral administration. Current U.S. labeling describes the tablets as white to off-white, round and convex, with a diameter of approximately 6 mm for one marketed presentation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |