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:

AvKARE

INN (International Name):

FLUDROCORTISONE ACETATE

Composition:

FLUDROCORTISONE ACETATE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludrocortisone Acetate Tablets USP, 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—Each white to off-white, round, convex tablet debossed with a "7033" on one side and with a bisect on the other side. Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .NDC 42291-529-01 Store at controlled room temperature 15° to 30°C (59° to 86°F)(see USP). Avoid excessive heat. Dispense in a tightly-closed, light-resistant container (USP). KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDROCORTISONE ACETATE- FLUDROCORTISONE ACETATE TABLET
AVKARE
----------
FLUDROCORTISONE ACETATE TABLETS USP
RX ONLY
RX ONLY
DESCRIPTION
Fludrocortisone Acetate Tablets USP, 0.1 mg 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-11β, 17,
21-trihydroxypregn-4-ene-3, 20- dione
21-acetate; its structural formula is:
Fludrocortisone Acetate Tablets USP, 0.1 mg are available for oral
administration as
scored tablets providing 0.1 mg fludrocortisone acetate per tablet.
Inactive ingredients:
croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate
NF, and
microcrystalline cellulose NF.
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 press