INFANT DEXTROSE- dextrose injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Boleh didapati daripada:

General Injectables & Vaccines, Inc

INN (Nama Antarabangsa):

Dextrose Monohydrate

Komposisi:

Dextrose Monohydrate 250 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% Dextrose Injection also provides a minimal source of carbohydrate calories. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.

Ringkasan produk:

25% Dextrose Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1057-4.0 Revised: August 2020

Status kebenaran:

New Drug Application

Ciri produk

INFANT DEXTROSE - DEXTROSE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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INFANT DEXTROSE 25% 250 MG/ML INJECTION, USP 10 ML PREFILLED SYRINGE
DESCRIPTION
25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic
solution of dextrose
in water for injection administered by intravenous injection to
restore blood glucose
levels in hypoglycemia and as a source of carbohydrate calories. Each
milliliter (mL) of
fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram
(0.85 kcal/mL).
The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 4.5
(3.2 to 6.5). May
contain hydrochloric acid and sodium hydroxide for pH adjustment. The
solution
contains no bacteriostat, antimicrobial agent or added buffer (except
for pH adjustment)
and is intended only for use as a single-dose injection. When smaller
doses are required
the unused portion should be discarded with the entire unit.
25% Dextrose Injection, USP is a dextrose (glucose) and nutrient
(carbohydrate)
replenisher. Dextrose, USP is chemically designated D-glucose
monohydrate,
(C6H12O6• H2O), a hexose sugar freely soluble in water.
It has the following structural formula:
The syringe is molded from a specially formulated polypropylene. Water
permeates from
inside the container at an extremely slow rate which will have an
insignificant effect on
solution concentration over the expected shelf life. Solutions in
contact with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the syringe
material.
CLINICAL PHARMACOLOGY
When administered intravenously, this solution restores blood glucose
levels in
hypoglycemia and provides a source of carbohydrate calories.
Carbohydrate in the form
of dextrose may aid in minimizing liver glycogen depletion and exerts
a protein-sparing
action. Dextrose injection undergoes oxidation to carbon dioxide and
water. 25%
Dextrose Injection, USP provides a concentrated solution sufficiently