DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cardinal Health

INN (mednarodno ime):

DEXAMETHASONE SODIUM PHOSPHATE

Sestava:

DEXAMETHASONE PHOSPHATE 4 mg in 1 mL

Pot uporabe:

INTRA-ARTICULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 acute episode o

Povzetek izdelek:

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 55154-7075-5 Overbagged with 5 vials per bag 1 mL Single-Dose Vial 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. Repackaged By: Cardinal Health Zanesville, OH 43701 L49929620716 Made in India MARCH 2015

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
CARDINAL HEALTH
----------
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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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 (hydrocortisone and cortiso