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FDA LABEL GENERIC: Glucose MFR: Baxter Healthcare Corporation

25 Ml Glucose 50 Mg/ml Injection

Table of Contents

1 INDICATIONS AND USAGE

Dextrose Injection (5% and 10%) is indicated as source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Dextrose Injection (5% and 10%) is intended for intravenous use. Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L. Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [ see Warnings and Precautions (5.4 )]. Avoid administering Dextrose Injection (5% and 10%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. If there is only a single IV access, flush the line thoroughly with normal saline before and after blood product administration. Use of a final filter is recommended during administration of parenteral solutions, where possible. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use promptly; do not store solutions containing additives. Discard the unused portion. To determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is the appropriate diluent.

2.2 Important Preparation Information

Visually inspect the Dextrose Injection (5% and 10%) for particulate matter and discoloration. Do not administer Dextrose Injection (5% and 10%) if the solution is cloudy, there are precipitates, or the container is damaged.

To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5% and 10%):

Use a non-vented infusion set or close the vent on a vented set. Use a dedicated line without any connections (do not connect flexible containers in series). The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.

To Open

Do not remove from overpouch until ready to use. Tear overwrap down side at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks. Visually inspect the 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. Evaluate the following: If the outlet port protector is damaged, detached, or not present, discard container. Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals. Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.

Preparation for Administration

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

To Add Medication

Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. Before adding a substance or medication, verify that it is soluble and/or stable in Dextrose Injection and that the pH range of Dextrose Injection is appropriate.

To Add Medication Before Solution Administration

Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.

To Add Medication During Solution Administration

Close clamp on the set. Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Return container to in-use position and continue administration.

2.3 Dosage Considerations

The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy.

Dextrose Injection (5% and 10%) patients’ tolerance of dextrose, especially for premature infants with low birth weight.

Increase the infusion rate gradually as needed; frequently monitor blood glucose concentrations to avoid hyperglycemia [ see Warnings and Precautions (5.2 ), Use in Specific Populations (8.4)].

3 DOSAGE FORMS AND STRENGTHS

Injection:

5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous a clear, sterile, non-pyrogenic solution in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL 10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in sing-dose partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL

4 CONTRAINDICATIONS

Dextrose Injection (5% and 10%) is contraindicated in patients with:

Clinically significant hyperglycemia [ see Warnings and Precautions (5.2 )]. Known hypersensitivity to dextrose [ see Warnings and Precautions (5.3 )].

5 WARNINGS AND PRECAUTIONS

5.1 Neonatal Hypoglycemia

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (5% and 10%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

The use of Dextrose Injection (5% and 10%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [ see Warnings and Precautions (5.6), Use in Specific Populations (8.4 )]. Patients with underlying CNS disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection (5% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration.

Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [ see Adverse Reactions (6)]. Stop administration immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [ see Dosage and Administration (2. 1 )]. If thrombophlebitis develops, remove the catheter as soon as possible.

Dextrose Injection (5% and 10%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs) [ see Drug Interactions (7.1), Use in Specific Populations (8.4)].

Avoid Dextrose Injection (5% and 10%) in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [ see Warnings and Precautions (5.6)] .

Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5% and 10%).

Depending on the administered volume and infusion rate, Dextrose Injection (5% and 10%) can cause fluid overload, including pulmonary edema.

Avoid Dextrose Injection (5% and 10%) in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, acid-base balance, especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load.

Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intake.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Neonatal Hypoglycemia [ see Warnings and Precautions (5.1)] Hyperglycemia and Hyperosmolar Hyperglycemic State [ see Warnings and Precautions (5.2)] Hypersensitivity Reactions [ see Warnings and Precautions (5.3)] Phlebitis and Thrombosis [ see Warnings and Precautions (5.4)] Hyponatremia [ see Warnings and Precautions (5.5)] Electrolyte Imbalance and Fluid overload [ see Warnings and Precautions (5.6)] Refeeding syndrome [ see Warnings and Precautions (5.7)]

The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis

Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash

Cardiovascular disorders: cyanosis, volume overload

7 DRUG INTERACTIONS

7.1 Effects on Glycemic Control and Electrolyte Balance

Dextrose Injection (5% and 10%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [ see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. Monitor patient’s blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance.

Concomitant administration of Dextrose Injection (5% and 10%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia. Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (5% and 10%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [ see Warnings and Precautions (5.5)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2 Lactation

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the effects of Dextrose Injection (5% and 10%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection (5% and 10%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5% and 10%) or from the underlying maternal condition.

8.4 Pediatric Use

Dextrose Injection (5% and 10%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose Injection (5% and 10%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [ see Warnings and Precautions (5.5, 5.6)].

In very low birth weight infants, excessive or rapid administration of Dextrose Injection (5% and 10%) may result in increased serum osmolality and risk of intracerebral hemorrhage.

8.5 Geriatric Use

Dextrose Injection (5% and 10%) has not been studied insufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [ see Warnings and Precautions (5.5)]. Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients. In general, the infusion rate for geriatric patients should start low and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose Injection (5% and 10%) is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5% and 10%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of infusion rate and patients should be closely monitored during Dextrose Injection (5% and 10%) treatment.

10 OVERDOSAGE

A medication error resulting in a high infusion rate of Dextrose Injection (5% and 10%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [ see Warnings and Precautions (5.2, 5.6)].

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5% and 10%) treatment, discontinue the infusion. Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [ see Warnings and Precautions (5.2, 5.6 )].

11 DESCRIPTION

Dextrose Injection, 5% and 10% USP are sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration as a source of water and calories.

Partial-fill containers, designed to facilitate admixture when necessary, are available in 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes. See Table 1 for the content and characteristics of this solution.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5).

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Strength Fill Volume Amount of Dextrose Hydrous per Container kcalCaloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrousper Container Osmolarity (mOsmol per liter)

Dextrose Injection 5%, USP
(0.05 grams/mL)

25 mL
Quad pack

1.25 grams

4.25

252

50 mL
Single pack
Quad pack
Multi pack

2.5 grams

8.5

252

100 mL
Single pack
Quad pack
Multi pack

5 grams

17

252

250 mL

12.5 grams

42.5

252

500 mL

25 grams

85

252

1000 mL

50 grams

170

252

Dextrose Injection 10%, USP
(0.1 grams/mL)

250 mL

25 grams

85

505

500 mL

50 grams

170

505

1000 mL

100 grams

340

505

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

Dextrose is derived from corn.

The VIAFLEX Plus plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution. Solutions in contact with the plastic container can leach out certain of its chemical components in small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. The safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

12.2 Pharmacodynamics

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

12.3 Pharmacokinetics

Dextrose is oxidized to carbon dioxide and water.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with dextrose to evaluate the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

Dextrose Injection (5% and 10%), USP is clear, colorless, sterile solutions of dextrose supplied in a single-dose, partial-fill flexible containers.

Product Description

Size

Code

NDC

Dextrose Injection 5%, USP
(5 g/100 mL) (50 mg/mL)

25 mL
Quad pack

2B0080

0338-0017-10

50 mL
Single pack
Quad pack
Multi pack


2B0086
2B0081
2B0088


0338-0017-41
0338-0017-11
0338-0017-31

100 mL
Single pack
Quad pack
Multi pack


2B0087
2B0082
2B0089


0338-0017-48
0338-0017-18
0338-0017-38

250 mL
500 mL
1000 mL

2B0062
2B0063
2B0064

0338-0017-02
0338-0017-03
0338-0017-04

Dextrose Injection 10%, USP
(10 g/100 mL) (100 mg/mL)

250 mL
500 mL
1000 mL

2B0162
2B0163
2B0164

0338-0023-02
0338-0023-03
0338-0023-04

Do not remove container from the overwrap until intended for use.

Use the product immediately after mixing and the introduction of additives.

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.

17 PATIENT COUNSELING INFORMATION

Manufactured by, Packed by, Distributed by:

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

Baxter and Viaflex are trademarks of Baxter International Inc.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

LOT

EXP

2B0063
NDC 0038-0023-03
DIN 00060364

10% Dextrose
Injection USP

500 mL

1

2

3

4

Each 100 mL contain 10 g Dextrose Hydrous USP
pH 4.0 (3.2 to 6.5) Hypertonic Osmolarity 505
mOsmol/L (calc) Sterile Nonpyrogenic Single dose
container Additives may be incompatible Consult with
pharmacist if available When introducing additives use
aseptic technique Mix thoroughly Do not store
Dosage Intravenously as directed by a physician See
directions 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 use
unless 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 PL 146 plastic

BAXTER VIAFLEX and PL 146 are trademarks of
Baxter International Inc

For product information 1-800-933-0303

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

Distribute in Canada By
Baxter Corporation
Toronto Ontario Canada

Container Label

LOT

EXP

2B0062
NDC 0038-0017-02

5% Dextrose
Injection USP

50

100

150

200

250 mL

Each 100 mL
contain 5 g
Dextrose Hydrous USP pH 4.0 (3.2 to 6.5)
Osmolarity 252 mOsmol/L (calc)
Sterile Nonpyrogenic
Single dose container Additives may
be incompatible Consult with
pharmacist if available When
introducing additives use aseptic
technique Mix thoroughly Do not
store Dosage Intravenously as
directed by a physician See
directions 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 use unless 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 PL 146 plastic

BAXTER VIAFLEX and PL 146 are
trademarks of Baxter International Inc

For product information 1-800-933-0303

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