DEXAMETHASONE SODIUM PHOSPHATE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Medical Purchasing Solutions, LLC

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

A. Intravenous or intramuscular administration 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: 1. 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 susp

Podsumowanie produktu:

Dexamethasone Sodium Phosphate Injection, USP (Preserved) 10 mg/mL is clear, colorless solution and is supplied as follows: The vial stopper closure is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store container in carton until contents are used. For Product Inquiry call 1-800-417-9175. Manufactured by:  Wintac Limited Bangalore 562 123 India. Code. No.: KR/DRUGS/KTK/28/289/97 Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 ST-DEX22/P/00 Issued: 01/ 2019

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 10 MG/ML
DESCRIPTION
Dexamethasone sodium phosphate injection, USP is a water-soluble
inorganic ester of
dexamethasone which produces a rapid response even when injected
intramuscularly.
Dexamethasone Sodium Phosphate, C
H
FNa
O
P, has a molecular weight of
516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11,
17-dihydroxy-16-methyl-
21 (phosphonooxy)-, disodium salt, (11β, 16α).
It occurs as a white to practically white powder, is exceedingly
hygroscopic, is soluble in
water and its solutions have a pH between 7.5 and 9.5. It has the
following structural
formula:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preserved)
10 mg/mL
contains dexamethasone sodium phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol;
and Water for
Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if
necessary. pH: 7.0 to
8.5.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone), which also have
salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their
synthetic analogs 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.
INDICATIONS AND USAGE
_A. INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION_
22
28
2
8
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:
_1. ENDOCRINE DISORDERS._
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the
drug of choice; synthetic analogs may be used in conjunction w