DEXLIDO KIT- dexamethasone sodium phosphate, lidocaine hydrochloride, povidine iodine kit

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Osta kohe

Laadi alla Toote omadused (SPC)
26-04-2022

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. Lidocaine Hydrochloride Injection USP, is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) 2 mL Ampules in a Carton of 10 NDC 55150-158-72 Sterile, Nonpyrogenic Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: October 2021

Volitamisolek:

unapproved drug other

Toote omadused

                                DEXLIDO KIT- DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE,
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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DEXLIDO KIT
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 
                                
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