DEXAMETHASONE SODIUM PHOSPHATE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Disponible desde:

Asclemed USA, Inc.

Vía de administración:

INTRA-ARTICULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

A. By intravenous or intramuscular injection when oral therapy is not feasible: 1. Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patie

Resumen del producto:

Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows: NDC Number Fill volume Pack size NDC 76420-185-01  (relabeled from NDC 67457-423-00) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing. •Cavanagh, D.; Singh, K. B.: Endotoxin shock in pregnancy and abortion, in: " Corticosteroids in the Treatment of Shock, " Schumer, W.; Nyhus, L. M., Editors, Urbana, University of Illinois Press, 1970, pp. 86–96.•Dietzman, R. H.; Ersek, R. A.; Bloch, J. M.; Lilleher, R. C.: High-output, low-resistance gram-negative septic shock in man, Angiology 20: 691–700, Dec. 1969.•Frank, E.: Clinical observations in shock and management (in: Shields, T. F., ed.: Symposium on current concepts and management of shocks), J. Maine Med. Ass . 59: 195 – 200, Oct. 1968.•Oaks, W. W.; Cohen, H. E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120–130, Mar. 1967.•Schumer, W.; Nyhus, L. M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg. 100: 405–408, Apr. 1970. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
ASCLEMED USA, INC.
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
RX ONLY
DESCRIPTION
Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is
a white or slightly yellow,
crystalline powder. It is freely soluble in water and is exceedingly
hygroscopic. The molecular weight
is 516.41. It is designated chemically as
9-fluoro-11β,17-dihydroxy-16α-methyl-21-
(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical
formula is C
H
FNa
O
P and the structural formula is:
Dexamethasone sodium phosphate injection, USP is a sterile solution of
dexamethasone sodium
phosphate, and is supplied in 4 mg/ mL.
Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile
solution for intravenous,
intramuscular, intra-articular, intralesional and soft tissue
administration. Each mL contains:
ACTIVE: Dexamethasone sodium phosphate 4.4 mg (equivalent to
dexamethasone phosphate 4 mg).
PRESERVATIVES: Methylparaben 1.5 mg; Propylparaben 0.2 mg. INACTIVES:
Edetate Disodium 0.11 mg;
Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide
q.s to adjust pH 7.0 to 8.5 and
Water for Injection q.s to 1 mL.
CLINICAL PHARMACOLOGY
Dexamethasone sodium phosphate injection has a rapid onset but short
duration of action when
compared with less soluble preparations. Because of this, it is
suitable for the treatment of acute
disorders responsive to adrenocortical steroid therapy.
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2
8
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
including dexamethasone, are primarily used for their potent
anti-inflammatory effects in disorders of
many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body's
immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely
l