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:

Becton Dickinson and Company

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient. 5% Dextrose Injection, USP 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. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. To Add Medication - Identify WHITE Additive Port with arrow pointing toward

Product summary:

5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 USA For product inquiry: 1-800-523-0502 Distributed by BD. Manufactured by Fresenius Kabi. Made in Norway. 451505B Revised: June 2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXTROSE - DEXTROSE MONOHYDRATE INJECTION, SOLUTION
BECTON DICKINSON AND COMPANY
----------
5% DEXTROSE INJECTION, USP
Rx only
DESCRIPTION:
5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is
a parenteral solution containing
dextrose in water for injection intended for intravenous
administration.
Each 100 mL of 5% Dextrose Injection, USP, contains dextrose
monohydrate, 5 g in water for injection.
The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L
(calc.), which is slightly hypotonic.
The solution pH is 4.3 (3.2 to 6.5).
This solution contains no bacteriostat, antimicrobial agent or added
buffer and is intended only as a
single-dose injection. When smaller doses are required the unused
portion should be discarded.
5% Dextrose Injection, USP is a parenteral fluid and nutrient
replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H O.
The flexible container is fabricated from a specially formulated
non-plasticized film containing
polypropylene and thermoplastic elastomers (FREE_flex_
bag). The amount of water that can permeate
from the container into the overwrap is insufficient to affect the
solution significantly. Solutions in
contact with the flexible container can leach out certain of the
container's chemical components in very
small amounts within the expiration period. The suitability of the
container material has been confirmed
by tests in animals according to USP biological tests for plastic
containers.
CLINICAL PHARMACOLOGY:
When administered intravenously, these solutions provide a source of
water and carbohydrate.
Isotonic and hypertonic concentrations of dextrose are suitable for
parenteral maintenance of water
requirements when salt is not needed or should be avoided.
Solutions containing carbohydrate in the form of dextrose restore
blood glucose levels and provide
calories. Carbohydrate in the form of dext