CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients with:oClinically significant hyperglycemia [see Warnings and Precautions (5.1)]. oKnown hypersensitivity to dextrose [see Warnings and Precautions (5.2)]. oClinically significant hyperglycemia [see Warnings and Precautions (5.1)]. oKnown hypersensitivity to dextrose [see Warnings and Precautions (5.2)]. oClinically significant hyperglycemia. (4)oKnown hypersensitivity to dextrose. (4). oClinically significant hyperglycemia. (4). oKnown hypersensitivity to dextrose. (4).

LACTATION SECTION.

8.2 Lactation Risk SummaryThere are no data on the presence of dextrose in human milk, the effects on breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action Dextrose is oxidized to carbon dioxide and water, yielding energy.

OVERDOSAGE SECTION.

10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)].Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems.If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS 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.The following clinically significant adverse reactions are described elsewhere in the labeling:oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]oHypersensitivity Reactions: anaphylaxis, pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2)]oInfusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis (10% dextrose only) [see Warnings and Precautions (5.3)]oHyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)]oElectrolyte imbalance, fluid overload andhypervolemia [see Warnings and Precautions (5.5)]oRefeeding syndrome [see Warnings and Precautions (5.6)]oPulmonary vascular precipitates (10% dextrose only). oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]. oHypersensitivity Reactions: anaphylaxis, pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2)]. oInfusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis (10% dextrose only) [see Warnings and Precautions (5.3)]. oHyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. oElectrolyte imbalance, fluid overload andhypervolemia [see Warnings and Precautions (5.5)]. oRefeeding syndrome [see Warnings and Precautions (5.6)]. oPulmonary vascular precipitates (10% dextrose only). 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.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dextrose is oxidized to carbon dioxide and water, yielding energy.

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, 150 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 grams17252150 mL7.5 grams25.5252250 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 chemicaly designated H2O.Dextrose is derived from corn.The VIAFLEX Plus plastic container is fabricated from specially formulated 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 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 parts per million. However, 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)oSee full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3). oOnly for intravenous infusion. (2.1). oSee full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3). 2.1 Important Administration Instructions oDextrose Injection is intended for intravenous use.oPeripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].oDo not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry. oPrior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.oUse of final filter is recommended during administration of parenteral solutions, where possible.. oDextrose Injection is intended for intravenous use.. oPeripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].. oDo not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.. oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry. oPrior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.. oUse of final filter is recommended during administration of parenteral solutions, where possible.. 2.2 Recommended Dosage The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patients tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. 2.3 Instructions for Use 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.Storage oUse promptly; do not store solutions containing additives. oSingle-dose container. oDiscard any unused portion. 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.. oUse promptly; do not store solutions containing additives. oSingle-dose container. oDiscard any unused portion.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection, USP is clear, sterile, non-pyrogenic solution of dextrose in single-dose containers:o5% (0.05 grams/mL): grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 250 mL, 500 mL, and 1000 mLo10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. o5% (0.05 grams/mL): grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 250 mL, 500 mL, and 1000 mL. o10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. Injection: o5% (0.05 grams/mL): grams of dextrose hydrous per 100 mL in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 250 mL, 500 mL, and 1000 mL. (3)o10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. (3). o5% (0.05 grams/mL): grams of dextrose hydrous per 100 mL in single-dose partial-fill flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 250 mL, 500 mL, and 1000 mL. (3). o10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in partial-fill flexible containers: 250 mL, 500 mL, and 1000 mL. (3).

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. (7.1). 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.4, 5.5)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

GERIATRIC USE SECTION.

8.5 Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. 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 other drug therapy.Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection 5% and 10%, USP are clear, colorless, sterile solutions of dextrose supplied in single-dose, partial-fill flexible containers.Product DescriptionSizeCodeNDCDextrose Injection 5%, USP(0.05 grams/mL)25 mLQuad pack2B00800338-0017-1050 mLSingle packQuad pack Multi pack2B00862B00812B00880338-0017-410338-0017-110338-0017-31100 mLSingle packQuad packMulti pack2B0087 2B00822B00890338-0017-480338-0017-180338-0017-38150 mL250 mL500 mL1000 mL2B00612B00622B00632B00640338-0017-010338-0017-020338-0017-030338-0017-04Dextrose Injection 10%, USP(0.1 grams/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 is indicated as source of water and calories.. Dextrose Injection is indicated as source of water and calories. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection:oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]oHypersensitivity reactions [see Warnings and Precautions (5.2)]oVein damage and thrombosis [see Warnings and Precautions (5.3)]oHyponatremia [see Warnings and Precautions (5.4)]oElectrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)]oRefeeding syndrome [see Warnings and Precautions (5.6)]Manufactured by, Packed by, Distributed by:Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in USA07-19-00-1441Baxter and Viaflex are trademarks of Baxter International Inc.. oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]. oHypersensitivity reactions [see Warnings and Precautions (5.2)]. oVein damage and thrombosis [see Warnings and Precautions (5.3)]. oHyponatremia [see Warnings and Precautions (5.4)]. oElectrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)]. oRefeeding syndrome [see Warnings and Precautions (5.6)].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Container Label LOTEXP5% DextroseInjection USP2B0061NDC 0038-0017-01150 mLEach 100 mL contains5 DextroseHydrousUSP pH 4.0 (3.2 to 6.5)Osmolarity 252 mOsmol/L (calc)SterileNonpyrogenic Single dose container Read package insert for fullinformation Additives may beincompatible Dosage Intravenously asdirected by physician CautionsSqueeze and inspect inner bag whichmaintains product sterility Discard ifleaks are found Must not be used inseries connections Do not administersimultaneously with blood Do notuseunless solution is clear Rx OnlyStore unit in moisture barrier overwrapat room temperature(25C/77F) untilready to use Avoid excessive heat SeeinsertViaflex container PL146 plasticBAXTER VIAFLEX and PL 146 aretrademarks of Baxter International IncFor product information 1-800-933-0303BaxterBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in USACarton Label Carton Label 2B006136-150 MLVIAFLEX(R) CONTAINER5% DEXTROSE INJECTION, USPSECONDARY BAR CODE(17) YYMMOO (10) XXXXXPRIMARY BAR CODE(01) 5030338017015EXPXXXXXLOTXXXXXContainer Label Container Label LOTEXP2B0063NDC 0038-0023-03DIN 0006036410% DextroseInjection USP500 mLEach 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 thorouhly Do not store Dosage Intravenously as directed by physician See cirections 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 CanadaCarton Label Carton Label 2B0063Q24-500 MLVIAFLEX(R) CONTAINER10% DEXTROSE INJECTION, USPSECONDARY BAR CODE(17) YYMMOO (10) XXXXXPRIMARY BAR CODE(01) 50303380023030EXPXXXXXLOTXXXXX. Dextrose Representative Container Label. Dextrose Representative Carton Label. Representative Container Label NDC 0338-0023-03. Representative Carton Label 0338-0023-03.

PEDIATRIC USE SECTION.

8.4 Pediatric Use The safety profile of Dextrose Injection in pediatric patients is similar to adults.Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].

PREGNANCY SECTION.

8.1 Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated 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.

Contraindications (4) 08/2019Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 08/2019.

SPL UNCLASSIFIED SECTION.

2.1 Important Administration Instructions oDextrose Injection is intended for intravenous use.oPeripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].oDo not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry. oPrior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.oUse of final filter is recommended during administration of parenteral solutions, where possible.. oDextrose Injection is intended for intravenous use.. oPeripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].. oDo not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.. oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry. oPrior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.. oUse of final filter is recommended during administration of parenteral solutions, where possible.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. (8.4). 8.1 Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated 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 SummaryThere are no data on the presence of dextrose in human milk, the effects on breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.. 8.4 Pediatric Use The safety profile of Dextrose Injection in pediatric patients is similar to adults.Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].. 8.5 Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. 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 other drug therapy.Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS oHyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.1)oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2)oVein Damage and Thrombosis: Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. (2.2, 5.3)oHyponatremia: Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. (5.4)oElectrolyte Imbalance and Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. (5.5)oRefeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6). oHyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.1). oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2). oVein Damage and Thrombosis: Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. (2.2, 5.3). oHyponatremia: Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. (5.4). oElectrolyte Imbalance and Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. (5.5). oRefeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6). 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State. The use of dextrose infusions 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 (5.5)]. 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. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.. 5.2 Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions (6)]. Stop infusion immediately and treat patient accordingly if signs or symptoms of hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.. 5.3 Vein Damage and Thrombosis Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of >= at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2. 1)]. The infusion of hypertonic solutions into peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.. 5.4 Hyponatremia 10% Dextrose Injection is hypertonic solution [see Description, Table (11)]. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.Depending on the tonicity of the solution, the volume and rate of infusion, and depending on patients underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia.The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted.Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations (8.4, 8.5)]. Avoid Dextrose Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.. 5.5 Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions.Depending on the volume and rate of infusion, the patients underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, (including hypoosmotic hyponatremia), overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution.Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and 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. Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations (8.4, 8.5)]. 5.6 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.