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DEXTROSE

 * Generic Name: hydrous dextrose
 * Brand Name: Dextrose Injection 5%

Last updated on RxList: 6/29/2021

home drugs a-z list dextrose injection 5% (hydrous dextrose) drug


DRUG SUMMARY

WHAT IS DEXTROSE?

Dextrose (hydrous dextrose) Injection is a fluid replenisher and caloric supply
used as a source of nutrition with water and calories. Dextrose injection is
available in generic form.

WHAT ARE SIDE EFFECTS OF DEXTROSE?

Common side effects of Dextrose injection include:

 * fever,
 * blood clots, and
 * infection or inflammation at the injection site

DOSAGE FOR DEXTROSE

Talk to your doctor about your individual dosage recommendation.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH DEXTROSE?

Some drugs may interact with Dextrose. Tell your doctor all medications you
take. Before taking Dextrose tell your doctor if you have diabetes.

DEXTROSE DURING PREGNANCY OR BREASTFEEDING

If you are pregnant only take Dextrose if clearly needed. Talk to your doctor
about taking Dextrose if you are breastfeeding.

ADDITIONAL INFORMATION

Our Dextrose (hydrous dextrose) Injection Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications & Dosage
 * Side Effects & Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR DEXTROSE INJECTION 5%

Dextrose (hydrous 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
Quad pack
50
Single pack
Quad pack 50 252 4.0
(3.2 to 6.5) 170 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









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.




USES FOR DEXTROSE INJECTION 5%

Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP is indicated as a
source of water and calories.


DOSAGE FOR DEXTROSE INJECTION 5%

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 (hydrous dextrose (hydrous dextrose) ) Injection, USP in VIAFLEX
plastic container is available as follows:



Code Size ( mL) NDC Product Name 2B0080 25 Quad pack 0338-0017-10 5% Dextrose
Injection, USP 2B0086 50 Single pack 0338-0017-41   2B0081   Quad pack
0338-0017-11 5% Dextrose Injection, USP 2B0088   Multi pack 0338-0017-31  
2B0087 100 Single pack 0338-0017-48   2B0082   Quad pack 0338-0017-18   2B0089  
Multi pack 0338-0017-38   2B0061 150   0338-0017-01 5% Dextrose Injection, USP
2B0062 250   0338-0017-02   2B0063 500   0338-0017-03   2B0064 1000  
0338-0017-04   2B0162 250   0338-0023-02   2B0163 500   0338-0023-03 10%
Dextrose Injection, USP 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 (25deg;C/
77deg;F); brief exposure up to 40deg;C/ 104deg;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 plastic 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. FDA revision date: n/a


SIDE EFFECTS FOR DEXTROSE INJECTION 5%

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.


DRUG INTERACTIONS FOR DEXTROSE INJECTION 5%

No information provided.


WARNINGS FOR DEXTROSE INJECTION 5%

Dextrose (hydrous dextrose (hydrous 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 (hydrous dextrose (hydrous dextrose) )
injections may result in significant hypokalemia.

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


PRECAUTIONS FOR DEXTROSE INJECTION 5%

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 (hydrous dextrose (hydrous 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 (hydrous dextrose (hydrous dextrose)
) Injection, USP can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Dextrose (hydrous dextrose (hydrous dextrose)
) Injection, USP should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

Dextrose (hydrous dextrose (hydrous 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 (hydrous dextrose (hydrous 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 (hydrous
dextrose (hydrous dextrose) ) is prescribed to pediatric patients, particularly
neonates and low birth weight infants.

GERIATRIC USE

Clinical studies of Dextrose (hydrous dextrose (hydrous 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 drug therapy.

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


OVERDOSE INFORMATION FOR DEXTROSE INJECTION 5%

No information provided.


CONTRAINDICATIONS FOR DEXTROSE INJECTION 5%

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


CLINICAL PHARMACOLOGY FOR DEXTROSE INJECTION 5%

Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP has value asa
source of water and calories. It is capable of inducing diuresis depending on
the clinical condition of the patient


PATIENT INFORMATION FOR DEXTROSE INJECTION 5%

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


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