DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE

Composition:

DEXAMETHASONE PHOSPHATE 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - 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 hyperplas

Product summary:

Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows: This container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light. Single dose vials–Store in container until time of use. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
Rx only
DESCRIPTION
Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble
inorganic ester of
dexamethasone which produces a rapid response even when injected
intramuscularly.
Dexamethasone Sodium Phosphate, USP chemically is
Pregna-1,4-diene-3,20-dione, 9-
fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt,
(11ß, 16α).
It occurs as a white to creamy 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:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (PRESERVATIVE
FREE)
contains dexamethasone sodium phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 24.75 mg sodium citrate, dihydrate; and Water for
Injection, q.s. pH
adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0
to 8.5.
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
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 su