DEXAMETHASONE SODIUM PHOSPHATE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

General Injectables and Vaccines, Inc.

INN (इंटरनेशनल नाम):

DEXAMETHASONE SODIUM PHOSPHATE

रचना:

DEXAMETHASONE PHOSPHATE 10 mg in 1 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

A. By intravenous or intramuscular injection when oral therapy is not feasible: 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 suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode o

उत्पाद समीक्षा:

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing. REFERENCES • Cavanagh, D.; Singh, K. B.: Endotoxin shock in pregnancy and abortion, in: "Corticosteroids in the Treatment of Shock," Schumer, W.; Nyhus, L. M., Editors, Urbana, University of Illinois Press, 1970, pp. 86–96. • Dietzman, R. H.; Ersek, R. A.; Bloch, J. M.; Lilleher, R. C.: High-output, low-resistance gram-negative septic shock in man, Angiology 20: 691–700, Dec. 1969. • Frank, E.: Clinical observations in shock and management (in: Shields, T. F., ed.: Symposium on current concepts and management of shocks), J. Maine Med. Ass. 59: 195 – 200, Oct. 1968. • Oaks, W. W.; Cohen, H. E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120–130, Mar. 1967. • Schumer, W.; Nyhus, L. M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg. 100: 405–408, Apr. 1970. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Made in India DECEMBER 2015

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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DEXAMETHASONE SODIUM PHOSPHATE
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-
11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione
disodium salt. The empirical formula is C22H28FNa2O8P and the
structural formula is:
Dexamethasone sodium phosphate injection, USP is a sterile solution of
dexamethasone
sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL.
Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile
solution for
intravenous, intramuscular, intra-articular, intralesional and soft
tissue administration.
Each mL contains:
Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to
dexamethasone
phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben
0.2 mg.
Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg;
Citric Acid
and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for
Injection q.s to 1
mL.
Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile
solution for
intravenous or intramuscular use only. Each mL contains:
Actives: Dexamethasone sodium phosphate 11 mg (equivalent to
dexamethasone
phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben
0.2 mg.
Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg;
Citric Acid
and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for
Injection q.s to 1
mL.
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),
whi