DEXAMETHASONE SODIUM PHOSPHATE injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Civica, Inc.

Rute administrasi :

INTRA-ARTICULAR

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 susp

Ringkasan produk:

Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 4 mg/mL 1 mL vials packaged in 25s (NDC 72572-120-25) 10 mg/mL 1 mL vials packaged in 25s (NDC 72572-122-25) 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 Hikma Pharmaceuticals USA Inc. 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 for: Civica, Inc. Lehi, Utah 84043 Manufactured by: Hikma Pharmaceuticals USA Inc. Cherry Hill, New Jersey 08003 Revised August 2019 462-815-00

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION
CIVICA, INC.
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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, 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
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used as replacement therapy in adrenocortical deficiency states. Their
synthetic analogs are primarily
used for their potent