DEXAMETHASONE SODIUM PHOSPHATES injection solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
13-01-2018

Aktivna sestavina:

dexamethasone phosphate (UNII: 2BP70L44PR) (dexamethasone - UNII:7S5I7G3JQL)

Dostopno od:

Cardinal Health

INN (mednarodno ime):

dexamethasone phosphate

Sestava:

dexamethasone phosphate 4 mg in 1 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

                                DEXAMETHASONE SODIUM PHOSPHATES- DEXAMETHASONE PHOSPHATE INJECTION,
SOLUTION
CARDINAL HEALTH
----------
DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, USP
RX ONLY
DESCRIPTION
Dexamethasone Sodium Phosphate Injection, USP is a water-soluble
inorganic ester of dexamethasone.
It occurs as a yellow crystalline powder, is odorless or has a slight
odor of alcohol, is exceedingly
hygroscopic, and is freely soluble in water.
Dexamethasone Sodium Phosphate Injection, USP is a synthetic
adrenocortical steroid anti-inflammatory
drug.
It has the following structural formula:
Dexamethasone Sodium Phosphate Injection, USP C
H FNa O P, has a molecular weight of 516.41
and the chemical name
9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
21-
(dihydrogen phosphate) disodium salt.
Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is a sterile
solution for intravenous,
intramuscular, intra-articular, intralesional and soft tissue
administration.
Each mL of the injection contains the following components:
CLINICAL PHARMACOLOGY
Dexamethasone Sodium Phosphate Injection, USP 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 cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
including dexamethasone, are primarily used for their potent
anti-inflammatory effects in disorders of
many organ systems.
22
28
2
8
Dexamethasone Sodium Phosphate
(equivalent to 4 mg of Dexamethasone Phosphate)...4.37 mg
Sodium
Sulfite.............................................................1
mg
Benzyl
Alcohol.............................................................10
mg
Sodium
Citrate.............................................................for
isotonicity
Water for
Injection....................................................
                                
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