DEXAMETHASONE SODIUM PHOSPHATE injection solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

REMEDYREPACK INC.

INN (שם בינלאומי):

DEXAMETHASONE SODIUM PHOSPHATE

הרכב:

DEXAMETHASONE PHOSPHATE 4 mg in 1 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
REMEDYREPACK INC.
----------
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 corti