DEXAMETHASONE SODIUM PHOSPHATE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

General Injectables & Vaccines, Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

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 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 adrenocorti