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Name:Dextrose
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


Dextrose Injection, USP in VIAFLEX Plastic Container

DEXTROSE - dextrose monohydrate injection, solution 
Baxter Healthcare Corporation

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Dextrose Injection, USP
in VIAFLEX Plastic Container

DESCRIPTION

Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.

Table 1
Size
(mL)
* Dextrose
Hydrous,
USP (g/L)
Osmolarity
(mOsmol/L)
(calc.)
pH Caloric
Content
(kcal/L)
5% Dextrose
Injection, USP
25 50 252 4.0
(3.2 to 6.5)
170
Quad pack
50
Single pack
Quad pack
Multi pack
100
Single pack
Quad pack
Multi pack
150
250
500
1000
10% Dextrose
Injection, USP
250
500
1000
100 505 4.0
(3.2 to 6.5)
340
D-Glucose monohydrate formula

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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 test for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Dextrose Injection, USP has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

INDICATIONS AND USAGE

Dextrose Injection, USP is indicated as a source of water and calories.

CONTRAINDICATIONS

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

WARNINGS

Dextrose Injection, USP 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.

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

PRECAUTIONS

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.

Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 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.

Pediatric Use

Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). 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.

Geriatric Use

Clinical studies of Dextrose Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Do not administer unless solution is clear and seal is intact.

ADVERSE REACTIONS

Reactions which may occur because of the injection 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.

DOSAGE AND ADMINISTRATION

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 VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

HOW SUPPLIED

Dextrose Injection, USP in VIAFLEX plastic container is available as follows:

Code Size
(mL)
NDC Product Name
  25    
2B0080 Quad pack 0338-0017-10 5% Dextrose Injection, USP
  50    
2B0086 Single pack 0338-0017-41 5% Dextrose Injection, USP
2B0081 Quad pack 0338-0017-11
2B0088 Multi pack 0338-0017-31
  100    
2B0087 Single pack 0338-0017-48 5% Dextrose Injection, USP
2B0082 Quad pack 0338-0017-18
2B0089 Multi pack 0338-0017-38
2B0061 150 0338-0017-01
2B0062 250 0338-0017-02
2B0063 500 0338-0017-03
2B0064 1000 0338-0017-04
2B0162 250 0338-0023-02 10% Dextrose Injection, USP
2B0163 500 0338-0023-03
2B0164 1000 0338-0023-04

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); brief exposure up to 40°C/104°F does not adversely affect the product.

Directions For Use Of VIAFLEX Plastic Container

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. 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 will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “To Add Medication” directions below.

Preparation for Administration

  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

  1. Prepare medication site.
  2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

  1. Close clamp on the set.
  2. Prepare medication site.
  3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  4. Remove container from IV pole and/or turn to an upright position.
  5. Evacuate both ports by squeezing them while container is in the upright position.
  6. Mix solution and medication thoroughly.
  7. Return container to in-use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-39-751

Rev. August 2003

Baxter VIAFLEX and PL 146 are trademarks of
Baxter International Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Dextrose Representative Container Label

Container Label

LOT

EXP

5% Dextrose
Injection USP

2B0061
NDC 0038-0017-01

150 mL

Each 100 mL contains
5 g DextroseHydrous
USP pH 4.0 (3.2 to 6.5)
Osmolarity 252 mOsmol/L (calc)
SterileNonpyrogenic Single dose


container Read package insert for full
information Additives may be
incompatible Dosage Intravenously as
directed by a physician Cautions
Squeeze and inspect inner bag which
maintains product sterility Discard if
leaks are found Must not be used in
series connections Do not administer
simultaneously with blood Do not
useunless solution is clear Rx Only
Store unit in moisture barrier overwrap
at room temperature(25°C/77°F) until
ready to use Avoid excessive heat See
insert

Viaflex container PL146 plastic

BAXTER VIAFLEX and PL 146 are
trademarks of Baxter International Inc

For product information 1-800-933-0303

Baxter
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA

Dextrose Representative Carton Label

Carton Label

2B0061

36-150 ML

VIAFLEX(R) CONTAINER

5% DEXTROSE INJECTION, USP

SECONDARY BAR CODE
(17) YYMMOO (10) XXXXX

PRIMARY BAR CODE
(01) 5030338017015

EXP
XXXXX

LOT
XXXXX


DEXTROSE 
dextrose monohydrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0017
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (DEXTROSE) DEXTROSE MONOHYDRATE 50 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0017-10 4 BAG ( BAG) in 1 PACKAGE contains a BAG
1 25 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-10)
2 NDC:0338-0017-41 1 BAG ( BAG) in 1 PACKAGE contains a BAG
2 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-41)
3 NDC:0338-0017-11 4 BAG ( BAG) in 1 PACKAGE contains a BAG
3 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-11)
4 NDC:0338-0017-31 16 BAG ( BAG) in 1 PACKAGE contains a BAG
4 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-31)
5 NDC:0338-0017-48 1 BAG ( BAG) in 1 PACKAGE contains a BAG
5 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-48)
6 NDC:0338-0017-18 4 BAG ( BAG) in 1 PACKAGE contains a BAG
6 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-18)
7 NDC:0338-0017-38 16 BAG ( BAG) in 1 PACKAGE contains a BAG
7 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0017-38)
8 NDC:0338-0017-01 150 mL in 1 BAG None
9 NDC:0338-0017-02 250 mL in 1 BAG None
10 NDC:0338-0017-03 500 mL in 1 BAG None
11 NDC:0338-0017-04 1000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA016673 06/16/2010

DEXTROSE 
dextrose monohydrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0023
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (DEXTROSE) DEXTROSE MONOHYDRATE 100 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0023-02 250 mL in 1 BAG None
2 NDC:0338-0023-03 500 mL in 1 BAG None
3 NDC:0338-0023-04 1000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA016694 06/16/2010

Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare SA dba Baxter Healthcare of Puerto Rico 189326168 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 MANUFACTURE

Revised: 06/2010 Baxter Healthcare Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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