DEXTROSE- dextrose monohydrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Henry Schein, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.]

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
HENRY SCHEIN, INC.
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50% DEXTROSE 0.5 GM/ML INJECTION, USP 50 ML PREFILLED SYRINGE
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
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