DEXAMETHASONE SODIUM PHOSPHATE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Medical Purchasing Solutions, LLC

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 e

Podsumowanie produktu:

Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 4 mg/mL 1 mL vials packaged in 25s (NDC 0641-6145-25) 5 mL vials packaged in 25s (NDC 0641-6146-25) 10 mg/mL 1 mL vials packaged in 25s (NDC 0641-0367-25) Protect from light: Keep covered in carton until time of use. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised November 2016 462-331-05

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
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, 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 molecular formula is: C
H
FNa
O
P and the structural formula is:
Dexamethasone Sodium Phosphate Injection is a sterile solution of
dexamethasone
sodium phosphate for intravenous and intramuscular use. The 4 mg/mL
strength may
also be used for intra-articular, intralesional and soft tissue
administration.
Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains
dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone
phosphate or
3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium
sulfite anhydrous,
19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol
(preservative) in Water for Injection.
Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains
dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone
phosphate or
8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium
sulfite anhydrous,
22
28
2
8
16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol
(preservative) in Water for Injection.
The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or
citric acid used, if
needed, for pH adjustment. Sealed under nitrogen.
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 u