FLUDROCORTISONE

What it is

Florinef is fludrocortisone acetate tablets containing 0.1 mg (100 micrograms) of fludrocortisone acetate. Fludrocortisone acetate is a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity.

Approved indications

— Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease — Treatment of salt losing adrenogenital syndrome

Dosing overview

Florinef is preferably administered in conjunction with a glucocorticoid such as cortisone (10 to 37.5 mg daily in divided doses) or hydrocortisone (10 to 30 mg daily in divided doses).

Key safety warnings

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Chicken pox, measles, herpes zoster, or threadworm infestations can have a more serious or even fatal course in non-immune children or adults on corticosteroids. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR). Since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy; dietary salt restriction and potassium supplementation may be necessary. To avoid drug induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards.

Contraindications

Patients with systemic fungal infections. Patients with suspected or known hypersensitivity to fludrocortisone or any of the inactive ingredients.

PBS listing

Florinef tablets containing fludrocortisone acetate 100 micrograms are listed on the PBS as one restricted item with an ex-manufacturer price of A$10.08.

Regulatory history

Florinef was first approved on 19 March 1996.