Fludrocortisone Acetate (Page 3 of 3)
In Addison’s disease, the combination of fludrocortisone acetate tablets with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects.
The usual dose is 0.1 mg of fludrocortisone acetate daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Fludrocortisone acetate is preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses).
Salt-Losing Adrenogenital Syndrome
The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocortisone acetate daily.
Fludrocortisone Acetate Tablets USP are available as:
0.1 mg: Yellow, oval, flat-faced, beveled-edge tablet, scored on one side. Debossed with a “stylized b ” on one side and 997│1/10 on the scored side.
Available in bottles of 100 (NDC 0555-0997-02)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
AVOID EXCESSIVE HEAT
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In Canada By:
Mississauga, ON, Canada L5N 7K9
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. B 11/2019
Package/Label Display Panel
Warning: Potent Drug
| FLUDROCORTISONE ACETATE |
fludrocortisone acetate tablet
|Labeler — Teva Pharmaceuticals USA, Inc. (001627975)|
Revised: 11/2019 Teva Pharmaceuticals USA, Inc.
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