Dextrose monohydrate injection (5%)

Dextrose monohydrate injection (5%)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Dextrose monohydrate injection (5%) is a sterile intravenous solution that is FDA approved for the {{{indicationType}}} of is indicated as a source of water and calories and may also be used as diluent for reconstitution of a powdered drug product packaged in a vial with a 20 mm closure.. Common adverse reactions include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• 5% Dextrose Injection, USP is indicated as a source of water and calories and may also be used as diluent for reconstitution of a powdered drug product packaged in a vial with a 20 mm closure.

Dosing Information

• As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

• All injections in MINI-BAG Plus Containers are intended for intravenous administration using sterile equipment.

• Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier.

To Open

• Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity should diminish gradually.

• Prior to use, check that the vial adaptor cover is intact. Check the solution container for minute leaks by squeezing inner bag firmly. If leaks are found or if the vial adaptor cover is not intact, discard product as sterility may be impaired.

To Assemble and Reconstitute

• See other side for detailed instructions.

• Additives may be incompatible.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dextrose monohydrate injection (5%) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextrose monohydrate injection (5%) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Dextrose monohydrate injection (5%) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dextrose monohydrate injection (5%) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextrose monohydrate injection (5%) in pediatric patients.

Contraindications

• Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

• Dextrose injections should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

• The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

• Excessive administration of dextrose injections may result in significant hypokalemia.

• For use only with a single dose powdered drug vial with a 20 mm closure.

• Do not administer unless drug is completely dissolved and drug vial is empty.

• Additives may be incompatible.

• Do not remove drug vial at any time prior to or during administration.

• In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

PRECAUTIONS

General

• Do not administer unless solution is clear and all seals are intact. Dextrose injections should be used with caution in patients with overt or subclinical diabetes mellitus.

Laboratory Tests

• Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Adverse Reactions

Clinical Trials Experience

• Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

• If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Postmarketing Experience

There is limited information regarding Dextrose monohydrate injection (5%) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Dextrose monohydrate injection (5%) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been conducted with 5% Dextrose Injection, USP. It is also not known whether Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose Injection, USP should be given to a pregnant woman only if clearly needed.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dextrose monohydrate injection (5%) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dextrose monohydrate injection (5%) during labor and delivery.

Nursing Mothers

• Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing woman.

Pediatric Use

• Dextrose is safe and effective for the stated indications in pediatric patients. As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

Geriatic Use

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) in geriatric settings.

Gender

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dextrose monohydrate injection (5%) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dextrose monohydrate injection (5%) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Injection

Monitoring

There is limited information regarding Dextrose monohydrate injection (5%) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Dextrose monohydrate injection (5%) and IV administrations.

Overdosage

There is limited information regarding Dextrose monohydrate injection (5%) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Dextrose monohydrate injection (5%) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dextrose monohydrate injection (5%) Mechanism of Action in the drug label.

Structure

• 5% Dextrose Injection, USP in the MINI-BAG Plus Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered drug. It contains no antimicrobial agents. Each 100 mL contains 5 g of Dextrose Hydrous, USP. The osmolarity is 252 m0smol/L (calculated). The pH is 4.0 (3.2 to 6.5). The chemical structure for Dextrose Hydrous, USP is shown below.

pic

• The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient.

• The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25° C/77° F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Pharmacodynamics

• 5% Dextrose Injection, USP has value as a source of water and calories. It has a caloric content of approximately 170 kcal/L. It is capable of inducing diuresis depending on the clinical condition of the patient.

Pharmacokinetics

There is limited information regarding Dextrose monohydrate injection (5%) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Dextrose monohydrate injection (5%) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Dextrose monohydrate injection (5%) Clinical Studies in the drug label.

How Supplied

5% Dextrose Injection, USP in MINI-BAG Plus Container is available as follows:

Storage

• Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77° F).

Images

Drug Images

{{#ask: Page Name::Dextrose monohydrate injection (5%) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

pic

5% Dextrose Injection, USP Container Label

LOT EXP

5% Dextrose

Injection USP

MINI-BAG Plus Container

50mL

2B0040

NDC 0338-0551-11

EACH 50 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP

pH 4.0 (3.2 TO 6.5) OSMOLARITY 252 mOsmol/L

(CALC) STERILE NONPYROGENIC READ PACKAGE INSERT FOR FULL

INFORMATION ADDITIVES MAY BE INCOMPATIBLE DOSAGE

INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN CAUTIONS MUST NOT BE

USED IN SERIES CONNECTIONS DO NOT ADMINISTER SIMULTANEOUSLY

WITH BLOOD DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY

US PAT NOS 4 340 049 4 607 671 5 304 163

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

VIAFLEX SINGLE DOSE CONTAINER

PL 146 PLASTIC

BAXTER VIAFLEX MINI-BAG

AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

BREAK SEAL AND MIX BEFORE USE

pic

5% Dextrose Injection, USP Carton Label

Lot:PXX Exp:XX XX

QTY:80-50mL

Code: 2B0040

NDC: 0338-0551-11

5% DEXTROSE INJECTION, USP

IN MINI-BAG PLUS CONTAINER

(17) XXXX00 (10) PXX

(01) 50303380551113 {{#ask: Label Page::Dextrose monohydrate injection (5%) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Dextrose monohydrate injection (5%) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Dextrose monohydrate injection (5%) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• DEXTROSE

Look-Alike Drug Names

There is limited information regarding Dextrose monohydrate injection (5%) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.