5% DEXTROSE INJECTION, USP SOLUTION

Canada - English - Health Canada

Buy It Now

Active ingredient:
DEXTROSE
Available from:
BAXTER CORPORATION
ATC code:
B05BA03
INN (International Name):
CARBOHYDRATES
Dosage:
5G
Pharmaceutical form:
SOLUTION
Composition:
DEXTROSE 5G
Administration route:
INTRAVENOUS
Units in package:
11ML
Prescription type:
Ethical
Therapeutic area:
CALORIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0102181006; AHFS: 40:20.00
Authorization status:
APPROVED
Authorization number:
00060348
Authorization date:
2019-03-25

Documents

Page 1 of 9

PRESCRIBING INFORMATION

5% Dextrose Injection, USP

In AVIVA Plastic Container

Solution for Infusion

Intravenous Fluid and Nutrient Replenisher

Baxter Corporation

Mississauga, Ontario L5N 0C2

Canada

Date of Revision:

June 11, 2019

Submission Control No: 227512

Baxter and Aviva are Trademarks of Baxter International Inc.

Page 2 of 9

5% Dextrose Injection, USP

In AVIVA Plastic Container

SUMMARY PRODUCT INFORMATION

5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose

containers for intravenous administration. It contains no bacteriostatic or antimicrobial agents or added buffers.

The composition, osmolarity and approximate pH of 5% Dextrose Injection, USP are shown in Table 1.

Table 1. Product information

Product

Name

Package

Size

Composition

(g/L)

Osmolarity

(mOsmol/L)

Caloric Content (cal/L)

Dextrose

Hydrous*, USP

Dextrose

Injection,

00060348

250mL

3.2 – 6.5

* The dextrose is purified from corn and may contain fructose.

The flexible AVIVA plastic container is made with non-latex plastic materials specially designed for a wide range of parenteral

drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container

system is compatible with the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible

with the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The

solution contact materials do not contain PVC, DEHP or other plasticizers.

No safety issues of the plastic material were identified in Class VI U.S.Pharmacopeia (USP) testing for plastic containers.

The flexible container is a closed system and air is prefilled in the container to facilitate drainage. The container does not require

entry of external air during administration.

The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the

other port has a medication site for addition of supplemental medication. The primary function of the overwrap is to protect the

container from the physical environment.

ACTIONS

5% 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

5% Dextrose Injection, USP is indicated as a source of water and calories.

CONTRAINDICATIONS

5% Dextrose Injection, USP, is contraindicated in the following conditions:

Hypersensitive to any ingredient in the formulation or component of the container. For a complete listing, see the

Dosage Forms, Composition and Packaging section of the Prescribing Information.

Clinically significant hyperglycemia

Page 3 of 9

Known allergy to corn or corn products since dextrose in the product is purified from corn.

WARNINGS AND PRECAUTIONS

General

Normal physiologic isotonicity range is approximately 280-310 mOsmol/liter. Rapid administration of a large volume of 5%

Dextrose Injection, USP may cause hemolysis due to its relatively low osmolarity (see Table 1).

5% Dextrose Injection, USP (an electrolyte-free dextrose aqueous solution) should not be administered simultaneously with

blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

Excessive administration of this potassium-free product may result in significant hypokalemia.

5% Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Caution must be exercised in the administration of parenteral fluids to patients receiving corticosteroids or corticotropin.

This product may contain fructose as an impurity in the dextrose material. Exercise caution when the product is used in patients

with hereditary fructose intolerance. In these patients, fructose may result in hypoglycemia, metabolic acidosis, liver toxicity

which manifests as vomiting, nausea, sweating, jaundice, hemorrhage, seizures or coma or even death. The severity of the

reactions is dependent on the amount and duration of fructose intake.

WARNING: This product contains aluminum which 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.

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

Risk of Air Embolism

Do not connect flexible plastic containers in series connections. Such use could result in air embolism due to possible residual air

being drawn from the primary container before the administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the

residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism.

Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Hypersensitivity Reactions

Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, have been reported with 5% Dextrose

Injection, USP (see Adverse Reactions).

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop.

Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Dilution and other effects on serum electrolytes

Depending on the volume and rate of infusion and depending on a patient’s underlying clinical condition and capability to

metabolize dextrose, intravenous administration of dextrose can cause:

Hyperosmolality, osmotic diuresis and dehydration

Hypoosmolality

Electrolyte disturbances such as

Hypo- or hypoosmotic hyponatremia (see below),

Hypokalemia,

Page 4 of 9

Hypophosphatemia,

Hypomagnesemia,

Overhydration/Hypervolemia and, for example, congested states, including pulmonary congestion and edemaThe above effects

do not only result from the administration of electrolyte-free fluid but also from dextrose administration. In addition:

An increase in serum glucose concentration is associated with an increase in serum osmolarity. Osmotic diuresis

associated with hyperglycemia can result in or contribute to the development of dehydration and in electrolyte losses.

Hyperglycemia also causes a transcellular shift of water, leading to a decrease in extracellular sodium concentrations

and hyponatremia.

Since the dextrose in Dextrose 5% Injection, USP is metabolized, infusion of Dextrose 5% Injection, USP

corresponds to increasing the body’s load of free water, possibly leading to hypoosmotic hyponatremia.

Monitoring of serum sodium is particularly important. High volume infusion must be used under specific monitoring in patients

with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including syndrome of inappropriate

antidiuretic hormone secretion (SIADH)), due to the risk of hospital-acquired hyponatremia.

Hypoosmotic Hyponatremia

Acute hyponatremia can lead to acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea,

seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain

injury.

The risk for developing hypoosmotic hyponatremia is increased, for example,

in children

in elderly patients

in women

postoperatively

in persons with psychogenic polydipsia

The risk for developing encephalopathy as a complication of hypoosmotic hyponatremia is increased, for example,

in pediatric patients (≤16 years of age)

in women (in particular, premenopausal women)

in patients with hypoxemia

in patients with underlying central nervous system disease

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte

concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of

administration warrants such evaluation.

Particular caution is advised in patients at increased risk of and from water and electrolyte disturbances that could be aggravated

by increased free water load, hyperglycemia or possibly required insulin administration (see below).

Preventive and corrective measures must be instituted as clinically indicated.

Hyperglycemia

Rapid administration of dextrose solutions may produce substantial hyperglycemia which may result in or contribute to electrolyte

losses, dehydration and hypovolemia due to osmotic diuresis and a hyperosmolar syndrome. At certain clinical conditions it also

may increase the risk of hypoosmotic hyponatremia by shifting of intracellular water to extracellular space.

Use with caution in critically ill patients in whom hyperglycemia commonly occurs due to diabetes, impaired glucose tolerance,

impaired fasting glucose, or is stress-induced.

Page 5 of 9

Hyperglycemia may increase the risk of cardiac complications, infection, systemic sepsis, acute renal failure and even death in

certain clinical conditions, especially in acute stress conditions.

In order to avoid hyperglycemia the infusion rate should not exceed the patient’s ability to utilize glucose.

To reduce the risk of hyperglycemia-associated complications, the infusion rate must be adjusted to the level suitable to the

patient’s ability to utilize glucose and/or insulin administered if blood glucose levels exceed levels considered acceptable for the

individual patient.

5% Dextrose Injection, USP should be administered with caution in patients with, for example:

impaired glucose tolerance (such as in diabetes mellitus, renal impairment, or in the presence of sepsis, trauma, or shock),

severe malnutrition (risk of precipitating a refeeding syndrome),

thiamine deficiency, e.g., in patients with chronic alcoholism (risk of severe lactic acidosis due to impaired oxidative

metabolization of pyruvate),

water and electrolyte disturbances that could be aggravated by increased glucose and/or free water load (see above)

patients with ischemic stroke. Hyperglycemia has been implicated in increasing cerebral ischemic brain damage and

impairing recovery after acute ischemic strokes.

patients with severe traumatic brain injury (in particular during the first 24 hours following the trauma). Early hyperglycemia

has been associated with poor outcomes in patients with severe traumatic brain injury.

Newborns (see Special Populations/Pediatrics)

Prolonged intravenous administration of dextrose and associated hyperglycemia may result in decreased rates of glucose-

stimulated insulin secretion.

Refeeding Syndrome

Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium,

phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also

develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications.

MONITORING AND LABORATORY TESTS

Clinical evaluation and periodic laboratory determination 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 or the rate of

administration warrants such evaluation.

Carcinogenesis and Mutagenesis

Studies with 5% Dextrose Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or

effects on fertility.

SPECIAL POPULATIONS

Pregnancy and Lactation

There are no adequate data from the use of 5% Dextrose Injection, USP in pregnant or lactating women.

It is not known whether 5% Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. 5% Dextrose Injection, USP should be given to a pregnant woman only if clearly needed

Studies have not been conducted to evaluate the effects of 5% Dextrose Injection, USP on labour and delivery. Caution should

be exercised when administering this drug during labour and delivery.

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 5% Dextrose Injection, USP is administered to a nursing woman.

Page 6 of 9

Intrapartum maternal intravenous dextrose infusion may result in fetal insulin production, with an associated risk of fetal

hyperglycemia and metabolic acidosis as well as rebound hypoglycemia in the neonate.

Healthcare practitioners should carefully consider the potential risks and benefits for each specific patient before administering

5% Dextrose Injection, USP.

Pediatrics

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy

and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Pediatric Glycemia-related Issues

Newborns – especially those born premature and with low birth weight, are at increased risk of developing hypo- or

hyperglycemia. Close monitoring during treatment with intravenous dextrose solutions is needed to ensure adequate glycemic

control, in order to avoid potential long term adverse effects.

HYPOglycemia in the newborn can cause:

prolonged seizures,

coma, and

cerebral injury.

HYPERglycemia has been associated with

cerebral injury, including intraventricular hemorrhage,

late onset bacterial and fungal infection,

retinopathy of prematurity,

necrotizing enterocolitis,

bronchopulmonary dysplasia

increased oxygen requirements,

prolonged length of hospital stay, and

death

Pediatric Hyponatremia-related Issues

Children (including neonates and older children) are at increased risk of developing hypoosmotic hyponatremia as well as for

developing hyponatremic encephalopathy.

Acute hyponatremia can lead to acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea,

seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain

injury.

Plasma electrolyte concentrations should be closely monitored in the pediatric population.

Rapid correction of hypoosmotic hyponatremia is potentially dangerous (risk of serious neurologic complications). Dosage, rate,

and duration of administration should be determined by a physician experienced in pediatric intravenous fluid therapy.

Geriatrics

Clinical studies of 5% 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.

ADVERSE REACTIONS

Page 7 of 9

Reactions which may occur because of the solution or the technique of administration include infection at the site of injection,

venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

The list of adverse reactions in this Prescribing Information is based on post-marketing reports (see below).

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic

countermeasures and save the remainder of the fluid and administration set for examination if deemed necessary.

Post-marketing Adverse Reactions

The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class

(SOC), then, where feasible, by Preferred Term in order of severity.

IMMUNE SYSTEM DISORDERS: Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, including

reactions with mild manifestations, e.g., Pruritus, and reactions with severe manifestations, e.g., Bronchospasm, Cyanosis,

Angioedema and Hypotension; Pyrexia, Chills

METABOLISM AND NUTRITION DISORDERS: Hyperglycemia

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Rash

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Infusion site reactions including, Infusion site phlebitis,

Infusion site erythema

Other adverse reactions reported with other similar products include:

Hyponatremia, which may be symptomatic (see “Hypoosmotic hyponatremia” in WARNINGS AND PRECAUTIONS).

Hyponatremic encephalopathy

DRUG INTERACTIONS

Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with 5% Dextrose Injection, USP.

Both the glycemic effects of 5% Dextrose Injection, USP and its effects on water and electrolyte balance should be taken into

account when using 5% Dextrose Injection, USP in patients treated with other substances that affect glycemic control, or fluid

and/or electrolyte balance.

Caution is advised when administering 5% Dextrose Injection, USP to patients treated with drugs leading to an increased

vasopressin effect. The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water

excretion and may increase the risk of hyponatremia following treatment with intravenous fluids (See Warnings and Precautions

and Adverse Reactions)

Drugs stimulating vasopressin release such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin

reuptake inhibitors (SSRIs), 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsycotics, opioids.

Drugs potentiating vasopressin action such as chlorpropamide, non steroidal anti-inflammatories (NSAIDS),

cyclophosphamide.

Vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin.

Caution is advised when administering 5% Dextrose Injection, USP to patients treated with drugs that may increase the risk of

hyponatremia, such as diuretics and antiepileptics (e.g., oxcarbazepine).

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.

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, as well as concomitant

therapy. For pediatric patients, consult a physician experienced in pediatric intravenous fluid therapy.

5% Dextrose Injection, USP has an osmolarity of 252 mOsmol/L. Administration of hyperosmolar solutions may cause venous

irritation and phlebitis.

Page 8 of 9

Electrolyte supplementation may be indicated according to the clinical needs of the patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever

solution and container permit.

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

5% Dextrose Injection, USP in AVIVA plastic container is intended for intravenous administration using sterile equipment. It is

recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use of an in-line filter is recommended during administration of all parenteral solutions where possible.

Additives may be incompatible. When introducing additives to 5% Dextrose Injection, USP, the instructions for use of the

medication to be added and other relevant literature must be consulted.

Those additives known to be incompatible with dextrose should not be used. Consult with pharmacist if available. If in the

informed judgment of the physician it is deemed advisable to introduce additives, aseptic technique must be used.

Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of 5% Dextrose

Injection, USP is appropriate.

After addition, check for a possible color change and/or the appearance of precipitates, insoluble complexes or crystals.

Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

For single use only.

Discard any unused portion.

OVERDOSAGE

Excess administration of 5% Dextrose Injection, USP can cause significant disturbance in water and electrolyte balance,

hyperglycemia and corresponding complications (see Warnings and Precautions and Adverse Reactions). For example, severe

hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal.

Interventions include discontinuation of infusion of 5% Dextrose Injection, USP dose reduction, administration of insulin and/or

other measures as indicated for the specific clinical constellation.

Clinically significant overdose of 5% Dextrose Injection, USP product may, therefore, constitute a medical emergency.

DOSAGE FORM, COMPOSITION AND PACKAGING

How Supplied

Table 1 shows the composition, osmolarity, approximate pH, calories/litre, ionic concentration and available sizes of 5%

Dextrose Injection, USP in AVIVA Plastic Container.

Per 100 mL: Dextrose Hydrous 5 g, Water for Injection

Directions for use of AVIVA Plastic Container

WARNING: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air

(approximately 15 mL) being drawn from the primary container before administration of the fluid from the secondary container is

completed.

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

To Open

Tear overwrap down side at slit and remove solution container. Moisture and 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 and 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.

Page 9 of 9

Preparation for Administration

Caution: Do not use plastic containers in series connections

Caution: Use only with a non-vented set or a vented set with the vent closed.

Suspend container from eyelet support.

Remove plastic protector from outlet port at bottom of container.

Attach administration set. Refer to complete directions accompanying set.

To Add Medication

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 medications 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.

Storage

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Store at 15°C to 25°C

Baxter Corporation

Mississauga, ON L5N 0C2

Baxter and Aviva are trademarks of Baxter International Inc.

Last revised: June 11, 2019

Similar products

Search alerts related to this product

Share this information