DEXAMETHASONE SODIUM PHOSPHATE injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

REMEDYREPACK INC.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 10 mg/mL NDC: 70518-0532-01 NDC: 70518-0532-00 PACKAGING: 25 in 1 CARTON PACKAGING: 1 mL in 1 Vial, Type 0 Storage Protect from light: Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
REMEDYREPACK INC.
----------
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 used for their po