DOUBLEDEX KIT- dexamethasone sodium phosphate, povidine iodine kit

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Osta kohe

Laadi alla Toote omadused (SPC)
22-09-2020

Toimeaine:

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

Saadav alates:

Asclemed USA, Inc.

INN (Rahvusvaheline Nimetus):

Dexamethasone Sodium Phosphate

Koostis:

Dexamethasone Phosphate 10 mg in 1 mL

Manustamisviis:

INTRAMUSCULAR

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 or exacer

Toote kokkuvõte:

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. 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.

Volitamisolek:

unapproved drug other

Toote omadused

                                DOUBLEDEX KIT- DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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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.
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 modify the body’s
immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely
lacks the sodium-retaining

                                
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