LACTATION SECTION.

8.2 Lactation Risk SummaryDextrose Injection (5% and 10%) has been used for decades and is not expected to cause harm to 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 mothers 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.

MECHANISM OF ACTION SECTION.

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

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drugs carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

OVERDOSAGE SECTION.

10 OVERDOSAGE A medication error resulting in 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 )].

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling:oNeonatal Hypoglycemia [see Warnings and Precautions (5.1)]oHyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2)]oHypersensitivity Reactions [see Warnings and Precautions (5.3)]oPhlebitis and Thrombosis [see Warnings and Precautions (5.4)]oHyponatremia [see Warnings and Precautions (5.5)]oElectrolyte Imbalance and Fluid overload [see Warnings and Precautions (5.6)]oRefeeding 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 population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish causal relationship to drug exposure.Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosisImmune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rashCardiovascular disorders: cyanosis, volume overload. oNeonatal Hypoglycemia [see Warnings and Precautions (5.1)]. oHyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2)]. oHypersensitivity Reactions [see Warnings and Precautions (5.3)]. oPhlebitis and Thrombosis [see Warnings and Precautions (5.4)]. oHyponatremia [see Warnings and Precautions (5.5)]. oElectrolyte Imbalance and Fluid overload [see Warnings and Precautions (5.6)]. oRefeeding syndrome [see Warnings and Precautions (5.7)]. The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance. (6)To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with dextrose to evaluate the drugs carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dextrose provides 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.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS Dextrose Injection (5% and 10%) is contraindicated in patients with:oClinically significant hyperglycemia see Warnings and Precautions (5.2)].oKnown hypersensitivity to dextrose see Warnings and Precautions (5.3)].. oClinically significant hyperglycemia see Warnings and Precautions (5.2)].. oKnown hypersensitivity to dextrose see Warnings and Precautions (5.3)].. oClinically significant hyperglycemia. (4)oKnown hypersensitivity to dextrose. (4). oClinically significant hyperglycemia. (4). oKnown hypersensitivity to dextrose. (4).

DESCRIPTION SECTION.

11 DESCRIPTION Dextrose Injection, 5% and 10% USP are sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in polyvinylchloride flexible plastic container for intravenous administration as 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 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 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.Table 1. Contents and Characteristics of Dextrose Injection 5% and 10%, USPStrengthFill VolumeAmount of Dextrose Hydrous per ContainerkcalCaloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrousper ContainerOsmolarity (mOsmol per liter)Dextrose Injection 5%, USP(0.05 grams/mL)25 mLQuad pack 1.25 grams4.2525250 mLSingle packQuad packMulti pack2.5 grams8.5252100 mLSingle packQuad packMulti pack5 grams17252250 mL12.5 grams42.5252500 mL25 grams852521000 mL50 grams170252Dextrose Injection 10%, USP(0.1 grams/mL)250 mL25 grams85505500 mL50 grams1705051000 mL100 grams340505Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), 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 drug additive in 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 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.. Dextrose Hydrous Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION oOnly for intravenous infusion. (2.1)oInfusion rate depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. See full prescribing information for information on preparation, administration, dosing considerations. (2.1, 2.2, 2.3). oOnly for intravenous infusion. (2.1). oInfusion rate depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. See full prescribing information for information on preparation, administration, dosing considerations. (2.1, 2.2, 2.3). 2.1 Important Administration Instructions Dextrose Injection (5% and 10%) is intended for intravenous use.oUse peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.oConsider using central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.4)].oAvoid 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 single IV access, flush the line thoroughly with normal saline before and after blood product administration. oUse of final filter is recommended during administration of parenteral solutions, where possible. oIt is recommended that intravenous administration apparatus be replaced at least once every 24 hours.oUse promptly; do not store solutions containing additives. oDiscard the unused portion.oTo determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is the appropriate diluent.. Dextrose Injection (5% and 10%) is intended for intravenous use.. oUse peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.. oConsider using central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.4)].. oAvoid 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 single IV access, flush the line thoroughly with normal saline before and after blood product administration. oUse of final filter is recommended during administration of parenteral solutions, where possible. oIt is recommended that intravenous administration apparatus be replaced at least once every 24 hours.. oUse promptly; do not store solutions containing additives. oDiscard the unused portion.. oTo 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%):oUse non-vented infusion set or close the vent on vented set.oUse dedicated line without any connections (do not connect flexible containers in series). oThe use of pressure infusion is not recommended as 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. oIf using pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.To OpenoDo not remove from overpouch until ready to use. oTear 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.oVisually 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:oIf the outlet port protector is damaged, detached, or not present, discard container.oCheck to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.oCheck for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.Preparation for Administration 1.Suspend container from eyelet support. 2.Remove protector from outlet port at bottom of container. 3.Attach administration set. Refer to complete directions accompanying set. To Add Medication oAdditives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. oConsult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. oWhen introducing additives, consult the instructions for use of the medication to be added and other relevant literature. oBefore adding 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 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. 4.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals. 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.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use. 8.Return container to in-use position and continue administration.. oUse non-vented infusion set or close the vent on vented set.. oUse dedicated line without any connections (do not connect flexible containers in series). oThe use of pressure infusion is not recommended as 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. oIf using pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.. oDo not remove from overpouch until ready to use. oTear 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.. oVisually 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:oIf the outlet port protector is damaged, detached, or not present, discard container.oCheck to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.oCheck for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.. oIf the outlet port protector is damaged, detached, or not present, discard container.. oCheck to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.. oCheck for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.. 1.Suspend container from eyelet support. 2.Remove protector from outlet port at bottom of container. 3.Attach administration set. Refer to complete directions accompanying set. oAdditives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. oConsult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. oWhen introducing additives, consult the instructions for use of the medication to be added and other relevant literature. oBefore adding substance or medication, verify that it is soluble and/or stable in Dextrose Injection and that the pH range of Dextrose Injection is appropriate. 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. 4.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals. 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.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use. 8.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)].

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS Injection:o5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous clear, sterile, non-pyrogenic solution in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mLo10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in sing-dose partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. o5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous 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. o10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in sing-dose partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. Injection: o5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL. (3)o10% (10 g/100 mL)(100 mg/mL) of dextrose hydrous in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. (3). o5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL. (3). o10% (10 g/100 mL)(100 mg/mL) of dextrose hydrous in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. (3).

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS Effects on Glycemic Control and Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. (7.1). 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 patients 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)].

GERIATRIC USE SECTION.

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.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection (5% and 10%), USP is clear, colorless, sterile solutions of dextrose supplied in single-dose, partial-fill flexible containers.Product DescriptionSizeCodeNDCDextrose Injection 5%, USP(5 g/100 mL) (50 mg/mL)25 mLQuad pack2B00800338-0017-1050 mLSingle packQuad pack Multi pack2B00862B00812B00880338-0017-410338-0017-110338-0017-31100 mLSingle packQuad packMulti pack2B0087 2B00822B00890338-0017-480338-0017-180338-0017-38250 mL500 mL1000 mL2B00622B00632B00640338-0017-020338-0017-030338-0017-04Dextrose Injection 10%, USP(10 g/100 mL) (100 mg/mL)250 mL500 mL1000 mL2B01622B01632B01640338-0023-020338-0023-030338-0023-04Do 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 (25C/77F); brief exposure up to 40C/104F does not adversely affect the product.

INDICATIONS & USAGE SECTION.

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 diluent for reconstitution of powder or liquid drug product.. Dextrose Injection (5% and 10%) is indicated as source of water and calories in adults and pediatric patients, and may also be used as diluent for reconstitution of powder or liquid drug product. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION Manufactured by, Packed by, Distributed by:Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in USABaxter and Viaflex are trademarks of Baxter International Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Container Label LOTEXP2B0063NDC 0038-0023-03DIN 0006036410% DextroseInjection USP500 mL1234Each 100 mL contain 10 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 withpharmacist if available When introducing additives use aseptic technique Mix thoroughly Do not store Dosage Intravenously as directed by 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 (25C/77F) until ready to use Avoid excessive heat See insertViaflex container PL 146 plasticBAXTER VIAFLEX and PL 146 are trademarks of Baxter International IncFor product information 1-800-933-0303Baxter logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USADistribute in Canada By Baxter Corporation Toronto Ontario CanadaContainer Label Container Label LOTEXP2B0062NDC 0038-0017-025% DextroseInjection USP50100150200250 mLEach 100 mL contain 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 withpharmacist if available When introducing additives use aseptic technique Mix thoroughly Do not store Dosage Intravenously as directed by 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 (25C/77F) until ready to use Avoid excessive heatSee insertViaflex container PL 146 plasticBAXTER VIAFLEX and PL 146 aretrademarks of Baxter International IncFor product information 1-800-933-0303Baxter logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USA. Representative Container Label NDC 0338-0023-03. Dextrose 0338-0017 Representative Container Label.jpg.

PEDIATRIC USE SECTION.

8.4 Pediatric Use Dextrose Injection (5% and 10%) is indicated in pediatric patients as source of water and calories, and may also be used as diluent for reconstitution of 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.

PHARMACODYNAMICS SECTION.

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.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

PREGNANCY SECTION.

8.1 Pregnancy Risk Summary Dextrose Injection (5% and 10%) has been used for decades during labor and delivery. Although there are 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 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 to 4% and 15 to 20%, respectively.

RECENT MAJOR CHANGES SECTION.

Warnings and Precautions (5.1) 06/2026.

SPL UNCLASSIFIED SECTION.

2.1 Important Administration Instructions Dextrose Injection (5% and 10%) is intended for intravenous use.oUse peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.oConsider using central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.4)].oAvoid 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 single IV access, flush the line thoroughly with normal saline before and after blood product administration. oUse of final filter is recommended during administration of parenteral solutions, where possible. oIt is recommended that intravenous administration apparatus be replaced at least once every 24 hours.oUse promptly; do not store solutions containing additives. oDiscard the unused portion.oTo determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is the appropriate diluent.. Dextrose Injection (5% and 10%) is intended for intravenous use.. oUse peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.. oConsider using central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.4)].. oAvoid 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 single IV access, flush the line thoroughly with normal saline before and after blood product administration. oUse of final filter is recommended during administration of parenteral solutions, where possible. oIt is recommended that intravenous administration apparatus be replaced at least once every 24 hours.. oUse promptly; do not store solutions containing additives. oDiscard the unused portion.. oTo determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is the appropriate diluent.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. (8.4). 8.1 Pregnancy Risk Summary Dextrose Injection (5% and 10%) has been used for decades during labor and delivery. Although there are 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 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 to 4% and 15 to 20%, respectively.. 8.2 Lactation Risk SummaryDextrose Injection (5% and 10%) has been used for decades and is not expected to cause harm to 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 mothers 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 source of water and calories, and may also be used as diluent for reconstitution of 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.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS oNeonatal Hypoglycemia: Closely monitor blood glucose concentrations to ensure adequate glycemic control. (5.1)oHyperglycemia or Hyperosmolar Hyperglycemic State: Use with caution in patients with known subclinical or overt diabetes mellitus. (5.2)oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reactions occur. (5.3)oPhlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.2, 5.4)oHyponatremia: Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. (5.5)oElectrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (5.6)oRefeeding Syndrome: Monitor laboratory parameters. (5.7). oNeonatal Hypoglycemia: Closely monitor blood glucose concentrations to ensure adequate glycemic control. (5.1). oHyperglycemia or Hyperosmolar Hyperglycemic State: Use with caution in patients with known subclinical or overt diabetes mellitus. (5.2). oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reactions occur. (5.3). oPhlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.2, 5.4). oHyponatremia: Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. (5.5). oElectrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (5.6). oRefeeding Syndrome: Monitor laboratory parameters. (5.7). 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.. 5.2 Hyperglycemia and Hyperosmolar Hyperglycemic State. The use of Dextrose Injection (5% and 10%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at rate exceeding the patients 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.. 5.3 Hypersensitivity Reactions 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 hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.. 5.4 Phlebitis and Thrombosis The infusion of hypertonic solutions into 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.. 5.5 Hyponatremia 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)].. 5.6 Electrolyte Imbalance and Fluid Overload 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.. 5.7 Refeeding Syndrome 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.