FLUDROCORTISONE ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUDROCORTISONE ACETATE (UNII: V47IF0PVH4) (FLUDROCORTISONE - UNII:U0476M545B)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

FLUDROCORTISONE ACETATE

Composition:

FLUDROCORTISONE ACETATE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludrocortisone Acetate Tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome. Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

Product summary:

Fludrocortisone Acetate Tablets, USP 0.1 mg are Round, White Tablets, Scored, Debossed "W" on the plain side and "46" on scored side.     Bottles of 30 tablets     Bottles of 100 tablets Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Issued January 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDROCORTISONE ACETATE- FLUDROCORTISONE ACETATE TABLET
WEST-WARD PHARMACEUTICAL CORP
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FLUDROCORTISONE ACETATE TABLETS, USP
DES CRIPTION
Fludrocortisone Acetate Tablets contain fludrocortisone acetate, a
synthetic adrenocortical steroid
possessing very potent mineralocorticoid properties and high
glucocorticoid activity; it is used only
for its mineralocorticoid effects. The chemical name for
fludrocortisone acetate is 9-fluoro-
11ß,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate; its structural
formula is:
Fludrocortisone Acetate Tablets are available for oral administration
as scored tablets providing 0.1 mg
fludrocortisone acetate per tablet. Inactive ingredients: anhydrous
lactose, corn starch, lactose
monohydrate, magnesium stearate, sugar, and talc.
CLINICAL PHARMACOLOGY
Corticosteroids are thought to act, at least in part, by controlling
the rate of synthesis of proteins.
Although there are a number of instances in which the synthesis of
specific proteins is known to be
induced by corticosteroids, the links between the initial actions of
the hormones and the final metabolic
effects have not been completely elucidated.
The physiologic action of fludrocortisone acetate is similar to that
of hydrocortisone. However, the
effects of fludrocortisone acetate, particularly on electrolyte
balance, but also on carbohydrate
metabolism, are considerably heightened and prolonged.
Mineralocorticoids act on the distal tubules of
the kidney to enhance the reabsorption of sodium ions from the tubular
fluid into the plasma; they
increase the urinary excretion of both potassium and hydrogen ions.
The consequence of these three
primary effects together with similar actions on cation transport in
other tissues appear to account for
the entire spectrum of physiological activities that are
characteristic of mineralocorticoids. In small
oral doses, fludrocortisone acetate produces marked sodium retention
and increased urinary potassium
excretion. It also causes a rise in blood pressure, apparently because
of these ef