Fludrocortisone Acetate (Page 3 of 3)

Addison’s Disease

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.

HOW SUPPLIED

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:
Patheon, Inc.
Mississauga, ON, Canada L5N 7K9

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. B 11/2019

Package/Label Display Panel

NDC 0555-0997-02

Fludrocortisone
Acetate Tablets
USP

0.1 mg

Warning: Potent Drug

Rx only

100 Tablets

FLUDROCORTISONE ACETATE fludrocortisone acetate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0997 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUDROCORTISONE ACETATE (FLUDROCORTISONE) FLUDROCORTISONE ACETATE 0.1 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE D&C YELLOW NO. 10 ALUMINUM LAKE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC

Product Characteristics Color yellow Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code b;997;1;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0555-0997-02 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040425 02/14/2003

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2019 Teva Pharmaceuticals USA, Inc.