DEXAMETHASONE SODIUM PHOSPHATE - dexamethasone sodium phosphate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intravenous or Intramuscular Injection  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: •  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 syntheticanalogs 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 a

Product summary:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Protect from freezing.  Sensitive to heat.  Do not autoclave.   Protect from light. Store container in carton until contents have been used.   Do not use if precipitate is present.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
REMEDYREPACK INC.
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP
DESCRIPTION:
Dexamethasone sodium phosphate is a water-soluble inorganic ester of
dexamethasone. It occurs as a
white or slightly yellow crystalline powder, is odorless or has a
slight odor of alcohol, is exceedingly
hygroscopic and is freely soluble in water.
Dexamethasone sodium phosphate is an adrenocortical steroid
anti-inflammatory drug.
Chemically, dexamethasone sodium phosphate is
9-Fluoro-11ß,17,21-trihydroxy-16α-methylpregna-1,
4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt and has the
following structural formula:
Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of
dexamethasone sodium
phosphate in water for injection for intravenous (IV), intramuscular
(IM), intra-articular, soft-tissue or
intralesional use.
Each mL contains dexamethasone sodium phosphate equivalent to
dexamethasone phosphate 4 mg or
dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative;
sodium citrate dihydrate 11 mg;
sodium sulfite 1 mg as an antioxidant; Water for Injection q.s. Citric
acid and/or sodium hydroxide may
have been added for pH adjustment (7.0 to 8.5). Air in the container
is displaced by nitrogen.
CLINICAL PHARMACOLOGY:
Dexamethasone sodium phosphate 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.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body’s
immune responses to diverse stimuli.
At equipot