DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

DEXAMETHASONE SODIUM PHOSPHATE

Composição:

DEXAMETHASONE SODIUM PHOSPHATE 10 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile

Resumo do produto:

Dexamethasone Sodium Phosphate Injection is available as follows: Dexamethasone Sodium Phosphate Equivalent To 10 mL multiple dose vials packaged 10 per shelf carton. 10 mg per mL—For intravenous and intramuscular injection only. Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light. Multiple dose vials—store in carton until contents are used. Store at controlled room temperature 15°–30°C (59°–86°F).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE INJECTION
PHYSICIANS TOTAL CARE, INC.
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
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-11ß,17-dihydroxy-16a-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 is a sterile solution of
dexamethasone sodium phosphate,
and is supplied in 10 mg per mL.
Dexamethasone sodium phosphate injection 10 mg per mL is a sterile
solution for intravenous or
intramuscular use only.
Each mL contains: Dexamethasone sodium phosphate equivalent to 10 mg
dexamethasone phos-phate;
sodium citrate anhydrous 10 mg; sodium metabisulfite 1 mg; benzyl
alcohol 10 mg; water for injection
qs; pH is adjusted with citric acid and/or NaOH if necessary. pH:
7.0–8.5
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 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 equipotent anti-inflammatory doses, dexamethasone almost completely
lacks the sodium-retaining
property of hydrocortisone and closely related derivatives of
hydrocortisone.
INDICATIONS AND USAGE
A. BY INTRAVENOUS OR INTRAMUSC