DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Cardinal Health

Rute administrasi :

INTRAMUSCULAR

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 (t

Ringkasan produk:

Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows: Product No. NDC No. Strength Vial Size 500601 63323-506-01 10 mg per mL 1 mL vial, packaged in twenty-fives. Dexamethasone Sodium Phosphate Injection, USP (Preserved) equivalent to 10 mg dexamethasone phosphate, is supplied in a multiple dose vial as follows: Product No. NDC No. Strength Vial Size 501610 63323-516-10 100 mg per 10 mL (10 mg per mL) 10 mL vial, packaged in tens. This container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light. Single dose vials–Store in container until time of use.  Discard unused portion. Multiple dose vials–Store in container until contents are used.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
CARDINAL HEALTH
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY
Rx only
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, USP chemically is
Pregna-1,4-diene-3,20-dione, 9-fluoro- 11,17-
dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 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 Dexamethasone Sodium Phosphate Injection, USP (PRESERVATIVE
FREE) contains
dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone
phosphate; 24.75 mg sodium
citrate, dihydrate; and Water for Injection, q.s. pH adjusted with
citric acid or sodium hydroxide, if
necessary. pH: 7.0 to 8.5.
Each mL Dexamethasone Sodium Phosphate Injection, USP (PRESERVED)
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
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 mo