DEXAMETHASONE SODIUM PHOSPHATE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

HF Acquisition Co LLC, DBA HealthFirst

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 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 Congeni

Resumen del producto:

DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1370-1 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 20 mg/5 mL (4 mg/mL) 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 20 MG/5 ML (4
MG/ML) 5ML VIAL
SPL UNCLASSIFIED
Rx only
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
addit