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:

Amneal Pharmaceuticals of New York LLC

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 — Each white to off-white, round, convex tablet debossed with a “7033” on one side and with a bisect on the other side. They are available as follows: Bottles of 100:                                                NDC 0115-7033-01 Bottles of 500:                                                NDC 0115-7033-02 Bottles of 1000:                                              NDC 0115-7033-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Dispense in a tightly-closed, light-resistant container (USP). Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 11-2023-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDROCORTISONE ACETATE- FLUDROCORTISONE ACETATE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
FLUDROCORTISONE ACETATE TABLETS, USP
(0.1 MG)
RX ONLY
DESCRIPTION
Fludrocortisone acetate tablets USP, 0.1 mg 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 is 9-fluoro-11β, 17,
21-trihydroxypregn-4-ene-3, 20-
dione 21-acetate; its structural formula is:
C
H
FO MW 422.49
Fludrocortisone acetate tablets USP, 0.1 mg are available for oral
administration as
scored tablets providing 0.1 mg fludrocortisone acetate, USP 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
23
31
6
the entire spectrum of physiological activities that are
characteristic of
mineralocorticoids. In small oral