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Name:Dextrose
Manufacturer:General Injectables & Vaccines, Inc.
Category:Prescription Marketed Drugs


50% Dextrose Injection, USP 25 grams (0.5g/ml)

DEXTROSE  - dextrose injection, solution 
General Injectables & Vaccines, Inc.

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50% Dextrose Injection, USP 25 grams (0.5g/ml)

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:


Formula1

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

When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate
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
requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
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

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.

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

50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.
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 this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte
concentrations, overhydration, congested states or pulmonary edema.
Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix
thoroughly and do not store.
For peripheral vein administration:
The solution 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 only after suitable dilution.

PRECAUTIONS

Do not use unless the solution is clear and seal is intact. Discard unused portion.
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 a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose
injection 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 is well within the lumen of the vein and that extravasation does not occur. If
thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.
Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or
effects on fertility.
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.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be
exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

ADVERSE REACTIONS

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause 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, re-evaluate the patient and institute appropriate corrective measures.
See WARNINGS and PRECAUTIONS.

DOSAGE AND ADMINISTRATION

For peripheral vein administration:
Injection of the solution should be made slowly.
The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the
dextrose is retained when infused ata rate of 0.8 g/kg/hr.
In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually
adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination
should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting
pretreatment test results.
For central venous administration:
For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with
amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b)
after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.
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.
The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. See CONTRAINDICATIONS.

HOW SUPPLIED

50% Dextrose Injection, USP is supplied in single-dose containers as follows:

List No.
Container
Size
4902
Abboject Unit of Use Syringe
25 g in 50 mL
4902
LifeShield Abboject Uit of Use
25 g in 50 mL

Syringe with male luer lock


adapter and protected needle

6648
Fliptop Vial
25 g in 50 mL
7517
Ansyr Plastic Syringe
25 g in 50 mL
7517
Ansyr II Plastic Syringe
25 g in 50 mL

with syringe and barrel detached


Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended
that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

OUTER PACKAGE LABEL

Label1


DEXTROSE 
dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-902(NDC:0409-4902)
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextrose (Dextrose) Dextrose 0.5 g  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-902-34 1 CARTON ( CARTON) in 1 BAG contains a CARTON
1 1 SYRINGE, GLASS ( SYRINGE) in 1 CARTON This package is contained within the BAG (52584-902-34) and contains a SYRINGE, GLASS
1 50 mL in 1 SYRINGE, GLASS This package is contained within a CARTON and a BAG (52584-902-34)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019445 09/29/2010

Labeler - General Injectables & Vaccines, Inc. (108250663)

Revised: 09/2010 General Injectables & Vaccines, Inc.



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


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