Prescription Drug Information: Fludrocortisone Acetate (Page 2 of 2)

Pregnancy: Nonteratogenic Effects

Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism.

Maternal treatment with corticosteroids should be carefully documented in the infant’s medical records to assist in follow up.

Nursing Mothers

Corticosteroids are found in the breast milk of lactating women receiving systemic therapy with these agents. Caution should be exercised when fludrocortisone acetate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

ADVERSE REACTIONS

Most adverse reactions are caused by the drug’s mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.

When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.

Musculoskeletal – muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures.

Gastrointestinal – peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic – impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions and hives; reactions to skin tests may be suppressed.

Neurological – convulsions, increased intracranial pressure with papilledema (psuedo-tumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances.

Endocrine – menstrual irregularities; development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic – posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic – hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.

Allergic Reactions – allergic skin rash, maculopapular rash, and urticaria.

Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Development of hypertension, edema, hypokalemia, excessive increase in weight, and increase in heart size are signs of overdosage of fludrocortisone acetate. When these are noted, administration of drugs should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate should be with a reduced dose. Muscular weakness may develop due to excessive potassium loss and can be treated by administering a potassium supplement. Regular monitoring of blood pressure and serum electrolytes can help to prevent overdosage (see WARNINGS).

DOSAGE AND ADMINISTRATION

Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remission or exacerbations of the disease and stress (surgery, infection, trauma) (see WARNINGS and PRECAUTIONS, General).

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 tablets 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 tablets are 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 tablets daily.

HOW SUPPLIED

Fludrocortisone Acetate Tablets USP, 0.1 mg – Each white to off-white, round, convex tablet debossed with a “7033” on one side and with a bisect on the other side.
Unit dose packages of 50 (5 x 10) NDC 68084-288-65
Unit dose packages of 100 (10 x 10) NDC 68084-288-01

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(0.1 mg / 50 UD) NDC 68084-288-65 packaged from NDC 0115-7033
(0.1 mg / 100 UD) NDC 68084-288-01 packaged from NDC 0115-7033

Distributed by:
American Health Packaging Columbus, OH 43217

8228801/1122F

Package/Label Display Panel — Carton — 0.1 mg – 100 UD

0.1 mg Fludrocortisone Acetate Tablets Carton, 100 UD
(click image for full-size original)

NDC 68084- 288 -01

Fludrocortisone
Acetate
Tablets, USP

0.1 mg

100 Tablets (10 x 10)                 Rx Only

Each Tablet Contains:
Fludrocortisone acetate …………………………………………………..0.1 mg

Usual Dosage: See package insert for full prescribing information.

Warning: Potent drug

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Avoid excess heat.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0115-7033, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

428801 0228801/0220

Package/Label Display Panel— Carton — 0.1 mg – 50 UD

0.1 mg Fludrocortisone Acetate Tablets Carton, 50 UD
(click image for full-size original)

NDC 68084- 288 -65

Fludrocortisone
Acetate
Tablets, USP

0.1 mg

50 Tablets (5 x 10)                 Rx Only

Each Tablet Contains:
Fludrocortisone acetate …………………………………………………..0.1 mg

Usual Dosage: See package insert for full prescribing information.

Warning: Potent drug

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Avoid excess heat.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0115-7033, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

028865 0228865/1122

Package/Label Display Panel — Blister — 0.1 mg

0.1 mg Fludrocortisone Acetate Tablet Blister
(click image for full-size original)

Fludrocortisone Acetate Tablet USP

0.1 mg

FLUDROCORTISONE ACETATE fludrocortisone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-288(NDC:0115-7033)
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
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (round, convex tablets) Size 6mm
Flavor Imprint Code 7033
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-288-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-288-11)
1 NDC:68084-288-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-288-01)
2 NDC:68084-288-65 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68084-288-11)
2 NDC:68084-288-11 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68084-288-65)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040431 09/09/2008
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-288)

Revised: 01/2023 American Health Packaging

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