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:

Medical Purchasing Solutions, LLC

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE

Composition:

DEXAMETHASONE PHOSPHATE 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 patient over an ac

Product summary:

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 67457-423-12 1 mL Single-Dose Vial 25’s 67457-422-54 5 mL Multi-Dose Vial 25’s 67457-421-30 30 mL Multi-Dose Vial 25’s Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows: NDC Number Fill volume Pack size 67457-420-10 10 mL Multi-Dose Vial 10’s 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. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Made in India DECEMBER 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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 and 10 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.
Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile
solution for
intravenous or intramuscular use only. Each mL contains:
ACTIVES: Dexamethasone sodium phosphate 11 mg (equivalent to
dexamethasone
phosphate 10 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.
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2
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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.
Naturally occurring glucocorticoids (hydrocor