Dextrose

RECENT MAJOR CHANGES Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 05/2026 Contraindications ( 4 ) 05/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 05/2026

INDICATIONS AND USAGE 25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% Dextrose Injection also provides a minimal source of carbohydrate calories.

2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • For slow intravenous infusion only into a: ( 2.2 ) o Central vein, if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L approximately. o Peripheral vein, if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L approximately. • Individualize dosage based on the patient’s clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally. ( 2.3 ) • Discontinue infusion of concentrated dextrose solutions slowly. ( 2.4 ) 2.1 Preparation Instructions Prior to Administration Dextrose Injection is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion. Dextrose Injection is intended for use in the preparation of sterile, intravenous admixtures. Prior to administration, Dextrose Injection must be transferred to a separate PN container , diluted with other compatible intravenous fluids and used as an admixture in PN solutions. • Do not remove from overpouch until ready to use. • Tear protective overwrap 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. • Inspect Dextrose Injection prior to use. Opacity of the container may be observed due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check for minute leaks by squeezing the inner container firmly. If leaks are found, discard solution as sterility may be impaired. o Do not use unless solution is clear and container is intact. • Because additives may be incompatible, evaluate all additions for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1)] . Preparation for Admixing 1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). 2. Suspend container from eyelet support. 3. Remove plastic protector from outlet port at bottom of container. 4. Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. 5. The VIAFLEX plastic container should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry notation. 6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours. 2.2 Important Administration Instructions • Dextrose Injection is for admixing use only and is not for direct intravenous infusion . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids and used as an admixture in PN solutions . • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administratio …

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection 20%, 30%, 40%, 50%, and 70% USP are sterile, non-pyrogenic, hypertonic solutions of dextrose in single-dose, partial-fill, flexible containers. 500 mL fill volume in 1000 mL flexible container • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL Injection: Single-dose, partial-fill, flexible containers with ( 3 ): 500 mL fill volume in 1000 mL flexible container: • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL

4 CONTRAINDICATIONS Dextrose Injection (50%) is contraindicated in patients with: • Intracranial or intraspinal hemorrhage because Dextrose Injection (50%) can worsen cerebral edema by causing a fluid shift across the blood-brain barrier. • Severe dehydration because of the potential to worsen the patient’s hyperosmolar state. • Alcohol withdrawal because of the potential to precipitate Wernicke encephalopathy (WE) or cardiomyopathy in thiamine-deficient patients. • Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Intracranial or intraspinal hemorrhage. ( 4 ) • Severe dehydration. ( 4 ) • Alcohol withdrawal. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )

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 a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: • Pulmonary embolism due to pulmonary vascular precipitates [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) ] • Vein damage and thrombosis [see Warnings and Precautions (5.4) ] • H yponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] • Risk of infections [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, infection both systemic and at the injection site, and vein thrombosis or phlebitis. ( 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.

7 DRUG INTERACTIONS Drugs with 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 Drugs with 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) ] .

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. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Malnutrition in pregnant women is associated with adverse maternal and fetal outcomes (see Clinical Considerations). 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 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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. 8.2 Lactation Risk Summary There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a 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 mother’s 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. Plasma electrolyte concentrations should be closely monitored 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. Because of immature renal function, preterm infants receiving prolonged treatment with dextrose injection, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9) ]. Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] . Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. 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 (5.5)] . 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. This …

12.1 Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.

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. Table 1. Contents and Characteristics of Dextrose Injection 5% and 10%, USP Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per 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 (C 6 H 12 O 6 • H 2 O), 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. Dextrose Hydrous Structural Formula

10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.2 , 5.11) ] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion 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.

16 How Supplied/Storage and Handling How Supplied Dextrose Injection, USP (50%) is supplied as a clear, colorless solution in single-dose containers as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 50 mL LifeShield® Abboject® Unit of Use Syringe with Male Luer Lock adapter and protected needle 50% (25 g/50 mL) (0.5 g/mL) 0409-4902-34 Bundle of 10 50 mL Single-Dose Abboject® Syringe with Male Luer Lock Adapter 50% (25 g/50 mL) (0.5 g/mL) 0409-0505-25 Bundle of 10 50 mL Ansyr® II Plastic Syringe with syringe and barrel detached 50% (25 g/50 mL) (0.5 g/mL) 0409-7517-16 Tray of 25 50 mL Single-Dose Fliptop Vials 50% (25 g/50 mL) (0.5 g/mL) 0409-6648-02 Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-6648-02 Tray containing 25 50 mL Single-Dose Fliptop Vials NDC 0404-9847-50 1 Single-Dose Fliptop Vial per bag (Vial bears NDC 0409-6648-16) 25 g/50 mL (0.5 g/mL) NDC 0409-7517-16 Bundle containing 10 Ansyr II Plastic Syringe NDC 0404-9845-50 1 Ansyr II Plastic Syringe per bag (Syringe bears NDC 0409-7517-66) 25 g/50 mL (0.5mg/mL) Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Abboject® is a trademark of Abbott Laboratories. LifeShield® is the trademark of ICU Medical, Inc. and is used under license. To contact Pfizers Medical Information Department, please visit www.pfizermedinfo.com or call 1‐800‐438‐1985. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-8.0