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Name:Dextrose
Manufacturer:Hospira
Category:Prescription Marketed Drugs


20%, 30%, 40%, 50% and 70% Dextrose Injection, USP

DEXTROSE - dextrose hydrous injection, solution 
Hospira

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20%, 30%, 40%, 50% and 70%
Dextrose Injection, USP

CONCENTRATED DEXTROSE IN WATER

Concentrated source of carbohydrate calories for intravenous infusion.

NOTE: These solutions are hypertonic — see WARNINGS and PRECAUTIONS.

Partial-Fill Flexible Plastic Containers

Rx only

DESCRIPTION

20%, 30%, 40%, 50% and 70% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution.

Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See table under HOW SUPPLIED for summary of content and characteristics of these concentrated solutions.

The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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 plastic container materials.

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.

Dextrose Injection, USP is a parenteral fluid and nutrient replenisher.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6• H2O), a hexose sugar freely soluble in water. It has the following structural formula:

Image from Drug Label Content

Water for Injection, USP is chemically designated H2O.

CLINICAL PHARMACOLOGY

When administered intravenously, solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production, respectively).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments, and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

20%, 30%, 40%, 50% and 70% Dextrose Injection, USP (concentrated dextrose in water) in partial-fill containers is indicated for admixture with amino acids or dilution with other compatible I.V. fluids to provide variable final dextrose concentrations for intravenous infusion in patients whose condition requires parenteral nutrition.

CONTRAINDICATIONS

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.

WARNINGS

Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

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.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

FOR PERIPHERAL VEIN ADMINISTRATION

Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.

FOR CENTRAL VENOUS ADMINISTRATION

Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.

PRECAUTIONS

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin. When concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose to avoid rebound hypoglycemia.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy Category C.

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

Pediatric Use:

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

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

This product contains no more than 25 mcg/L of aluminum.

ADVERSE REACTIONS

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness.

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.

OVERDOSAGE

In the event of overhydration or solute overload during therapy, reevaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

DOSAGE AND ADMINISTRATION

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) After admixture with amino acid solutions or (b) After dilution with other compatible I.V. fluids. Dosage should be adjusted to meet the requirements of each individual patient.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight /hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

As reported in the literature, the dosage 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.

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.

A list of nutritional admixture values is appended.

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

Drug Interaction

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED

20%, 30%, 40%, 50% or 70% Dextrose Injection, USP are supplied in single-dose partial-fill flexible containers. See the following table.

Concentrated Dextrose In Water

Content and Characteristics

List No.

% Conc.

Fill Volume (mL)

Total Grams of Dextrose Hydrous Per Container

kcal*/100 mL

(Per Container)

mOsmol/liter

(calc.)

pH (range)

7935

20

500

100

68 (340)

1009

4.3 (3.2 - 6.5)

8004

30

500

150

102 (510)

1514

4.3 (3.2 - 6.5)

7937

40

500

200

136 (680)

2018

4.3 (3.2 - 6.5)

7936

50

500

250

170 (850)

2523

4.3 (3.2 - 6.5)

7918

70

500

350

238 (1190)

3532

4.3 (3.2 - 6.5)

7935

20

1000

200

68 (680)

1009

4.3 (3.2 - 6.5)

7936

50

1000

500

170 (1700)

2523

4.3 (3.2 - 6.5)

*Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous.

Nutritional Admixture Values

500 mL of Concentrated Dextrose mixed with 500 mL Aminosyn®7% or

1000 mL of Concentrated Dextrose mixed with 1000 mL of Aminosyn 7%

Dextrose

Pre-Dilution Concentration

Admixture

Non-Protein

kcal/g N

Admixture

Non-Protein

kcal/liter

Admixture

g N/liter

Admixture

Dextrose

Concentration

20%

62

340

5.5

10%

30%

93

510

5.5

15%

40%

124

680

5.5

20%

50%

155

850

5.5

25%

70%

216

1190

5.5

35%

Exposure of pharmaceutical products to heat should be minimized. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

©Hospira 2005

EN-1037

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA


DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7935
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 20 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7935-19 12 BAG In 1 CASE contains a BAG
1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7935-19)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-8004
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 30 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-8004-15 12 BAG In 1 CASE contains a BAG
1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-8004-15)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7937
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 40 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7937-19 12 BAG In 1 CASE contains a BAG
1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7937-19)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7936
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 50 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7936-19 12 BAG In 1 CASE contains a BAG
1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7936-19)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7918
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 70 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7918-19 12 BAG In 1 CASE contains a BAG
1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7918-19)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7935
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 20 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7935-29 6 BAG In 1 CASE contains a BAG
1 1000 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7935-29)

DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7936
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Dextrose Hydrous (Dextrose) Active 50 GRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-7936-29 6 BAG In 1 CASE contains a BAG
1 1000 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-7936-29)

Revised: 05/2006 Hospira



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


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