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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

FLUDROCORTISONE ACETATE

Composition:

FLUDROCORTISONE ACETATE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludrocortisone acetate tablets 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. Fludrocortisone acetate tablets (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 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDROCORTISONE ACETATE- FLUDROCORTISONE ACETATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
FLUDROCORTISONE ACETATE TABLETS USP
RX ONLY
DESCRIPTION
Fludrocortisone Acetate Tablets USP contain fludrocortisone acetate,
USP, 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, USP is 9-fluoro-11_ß_, 17,
21-trihydroxypregn-4-ene-3,20-
dione 21-acetate. The structural formula is as follows:
C
H
FO M.W. 422.49
Fludrocortisone Acetate Tablets USP are available for oral
administration as scored
tablets providing 0.1 mg fludrocortisone acetate, USP per tablet. In
addition, each tablet
contains the following inactive ingredients: anhydrous lactose, corn
starch, dibasic
calcium phosphate, D&C yellow no. 10 aluminum lake, magnesium
stearate, sodium
starch glycolate, 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
23
31
6
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 d