Description

Fludrocortisone acetate 0.1 mg tablets are used for partial replacement therapy in primary adrenocortical insufficiency (Addison’s disease) and for the treatment of salt-losing adrenogenital syndrome. They are available in bottle sizes of 30, 50, 100, 500, and 1000 tablets.Fludrocortisone acetate is a synthetic adrenocortical steroid with potent mineralocorticoid properties and high glucocorticoid activity. It works by enhancing sodium reabsorption in the kidneys and promoting potassium and hydrogen ion excretion.

Formulation

• Fludrocortisone acetate 0.1 mg per tablet
• White to off-white, round, convex tablets with a score line and imprint

Packaging

• Available in bottles of 100 tablets

Indications

• Used for partial replacement therapy in primary adrenocortical insufficiency (Addison’s disease)
• Treats salt-losing adrenogenital syndrome

Dosing

• Typical adult dose is 0.1 mg daily, but can range from 0.1 mg 3 times per week to 0.2 mg daily
• If hypertension develops, the dose should be reduced to 0.05 mg daily

Mechanism of Action

• Synthetic adrenocortical steroid with potent mineralocorticoid and high glucocorticoid activity
• Enhances sodium reabsorption and promotes potassium/hydrogen ion excretion in the kidneys                                                                                                                                        Fludrocortisone acetate, the active ingredient in Florinef 0.1mg tablets, has a potent mineralocorticoid mechanism of action along with some additional glucocorticoid activity.Specifically, fludrocortisone:
  • Enhances sodium reabsorption and promotes potassium and hydrogen ion excretion in the kidneys
  • Inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion
  • Promotes the deposition of liver glycogen
  • Induces negative nitrogen balance unless protein intake is adequate

  Fludrocortisone acetate is a prodrug that is hydrolyzed into the active fludrocortisone in the body. Relative to cortisol, fludrocortisone has 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency.The approximate half-life of fludrocortisone is 18-36 hours. It is highly protein bound and eliminated mostly as inactive metabolites by the kidneys. Its duration of action is 1 to 2 days.                                                                          The chemical structure of fludrocortisone acetate, the active ingredient in Florinef 0.1mg tablets, is:

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  Key Benefits

  • Provides partial replacement therapy for primary adrenocortical insufficiency (Addison’s disease)
  • Treats salt-losing adrenogenital syndrome by promoting sodium retention and fluid balance
  • Helps restore normal adrenal function when used in combination with a glucocorticoid like hydrocortisone

  Key Ingredients

  • Active ingredient: Fludrocortisone acetate 0.1 mg per tablet
  • Inactive ingredients:
    • Lactose
    • Lactose monohydrate
    • Calcium hydrogen phosphate dihydrate
    • Maize starch
    • Magnesium stearate
    • Purified talc
    • Sodium benzoate

   

  Dosage

  • Typical adult dose is 0.1 mg daily, ranging from 0.1 mg 3 times per week to 0.2 mg daily
  • If hypertension develops, reduce dose to 0.05 mg daily
  • Use with a glucocorticoid like hydrocortisone or cortisone for Addison’s disease
  • Recommended dose for salt-losing adrenogenital syndrome is 0.1 to 0.2 mg daily

  Storage

  • Store refrigerated between 2-8°C
  • Can be stored below 25°C for up to 3 months, then discard unused tablets
  • Keep out of reach of children