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

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: Dexamethasone Sodium Phosphate Injection, USP (Preserved) 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. Multiple dose vials–Store in container until contents are used. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45955F Revised: July 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR 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.
Each mL Dexamethasone Sodium Phosphate Injection, USP (PRESERVED)
contains dexamethasone
sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate;
13.5 mg sodium citrate,
dihydrate; 10 mg benzyl alcohol; 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 prod