DEXAMETHASONE SODIUM PHOSPHATE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Somerset Therapeutics, LLC

מסלול נתינה (של תרופות):

INTRA-ARTICULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Dexamethasone sodium phosphate injection, USP 4 mg/mL 1-mL single dose vial, NDC 70069-022 -01 1-mL single dose vial, box of 25, NDC 70069-022 -25 5-mL multiple dose vial, NDC 70069-023 -01 5-mL multiple dose vial, box of 25, NDC 70069-023 -25 30-mL multiple dose vial, NDC 70069-024 -01 30-mL multiple dose vial, box of 25, NDC 70069-024 -25 Protect from light. Store at 20°–25°C (68°– 77°F). CAUTION: Federal law prohibits dispensing without a prescription. 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-DEX/P/00 Issued: June 2018

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION
SOMERSET THERAPEUTICS, LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 4 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 creamy white powder, is exceedingly
hygroscopic, is soluble in water and its
solutions have a pH between 7.0 and 8.5. It has the following
structural formula:
Each mL of the Dexamethasone sodium phosphate injection 4 mg/mL,
contains dexamethasone sodium
phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 1 mg
sodium sulfite; 10 mg benzyl
alcohol (preservative), made isotonic with sodium citrate dihydrate.
pH adjusted with citric acid
monohydrate or sodium hydroxide.
ACTIONS
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
_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