DEXTROSE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Henry Schein, Inc.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Descriptif du produit:

50% Dextrose Injection, USP is supplied in single-dose containers as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

DEXTROSE- DEXTROSE INJECTION, SOLUTION
HENRY SCHEIN, 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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50% DEXTROSE INJECTION, USP 25 GRAMS (0.5G/ML)
NOTE: This solution is hypertonic - See WARNINGS and PRECAUTIONS.
LifeShield® Abboject® Syringe Fliptop Container
Ansyr™ II Plastic Syringe
Rx only
DESCRIPTION
50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic
solution of dextrose
in water for injection for intravenous injection
as a fluid and nutrient replenisher.
Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4
kcal/gram. The
solution has an osmolarity of 2.53 mOsmol/mL
(calc.), a pH of 4.2 (3.2 to 6.5) and may contain sodium hydroxide
and/or hydrochloric
acid 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.
Dextrose, USP is chemically designated C6H12O6• H2O (D-glucose
monohydrate), a
hexose sugar freely soluble in water. Dextrose,
hydrous has the following structural formula:
Water for Injection, USP is chemically designated H2O .
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 deple