FLUDROCORTISONE ACETATE- fludrocortisone acetate tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

PD-Rx Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

FLUDROCORTISONE ACETATE

Composição:

FLUDROCORTISONE ACETATE 0.1 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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 60 (NDC 43063-714-60) 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FLUDROCORTISONE ACETATE- FLUDROCORTISONE ACETATE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
FLUDROCORTISONE ACETATE TABLETS USP
0997
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:
1. 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 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 dos