DEXAMETHASONE SODIUM PHOSPHATE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

General Injectables & Vaccines, Inc.

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

A. Intravenous or intramuscular administration.  When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 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

leaflet_short:

Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: 4 mg per mL 1 mL Single-Dose Vials in a carton of 25                                           NDC 55150-237-01 20 mg per 5 mL (4 mg / mL)  5 mL Multiple-Dose Vials in a carton of 25                                          NDC 55150-238-05 120 mg per 30 mL (4 mg / mL) 30 mL Multiple-Dose Vials in a carton of 25                                          NDC 55150-239-30 Store at  20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sensitive to heat - Do not autoclave. Protect from light. The vial stoppers are not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited  Hyderabad - 500038 India Revised: July 2017

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP
RX ONLY
DESCRIPTION
Dexamethasone sodium phosphate injection USP is a sterile, clear,
colorless solution,
free from visible particles and a water-soluble inorganic ester of
dexamethasone which
produces a rapid response even when injected intramuscularly.
Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular
weight of
516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11,
17-dihydroxy-16-methyl-
21 (phosphonooxy)-, disodium salt, (11β, 16α).
It occurs as a white to practically white powder, is exceedingly
hygroscopic, is soluble in
water and its solutions have a pH between 7.0 and 8.5. It has the
following structural
formula:
Dexamethasone sodium phosphate injection USP is available in 4 mg/mL
concentration.
Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL,
contains 4.37
mg of dexamethasone sodium phosphate, USP equivalent to 4 mg
dexamethasone
phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative).
Made isotonic with
sodium citrate. pH adjusted with citric acid or sodium hydroxide.
ACTIONS — Naturally occurring glucocorticoids (hydrocortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs 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.
INDICATIONS AND USAGE
_A. INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION._ When oral therapy is
not feasible
and the strength, dosage form, and route of administration of the drug
reasonably lend
and the strength, dosage form, and route of administration of the drug
reasonably lend
the preparation to the treatment of the condition, those products
labeled for
intravenous or intramu