These Highlights Do Not Include All The Information Needed To Use Dextrose Injection (5%) Safely And Effectively. See Full Prescribing Information For Dextrose Injection (5%).

A medication error resulting in a high infusion rate of Dextrose Injection (5%) 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%) 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)].

Risk Summary

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

The background risk of major birth defects and miscarriage for the indicated populations are 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.

Risk Summary

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

Dextrose, USP is chemically designated D-glucose, monohydrate (C₆H₁₂O₆ • H₂O), a hexose sugar freely soluble in water.

The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)].

Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 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 supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5).

Dextrose is derived from corn.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

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

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

Neonates, especially preterm neonates 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%) 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 neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.

Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and 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 slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) 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 the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.

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

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

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

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

The following adverse reactions associated with the use of Dextrose Injection (5%) were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

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

Cardiovascular disorders: cyanosis, volume overload

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

Dextrose is oxidized to carbon dioxide and water.

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.

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

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

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%) administration rate should be based on the patient’s tolerance of dextrose, especially for preterm neonates 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)].

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%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

• •
  Neonatal Hypoglycemia: Closely monitor blood glucose concentration to ensure adequate glycemic control. (5.1)
• •
  Hyperglycemia and Hyperosmolar Hyperglycemic State: Use with caution in patients with known subclinical or overt diabetes mellitus. (5.2)
• •
  Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. (5.3)
• •
  Phlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.1, 5.4)
• •
  Hyponatremia: Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. (5.5)
• •
  Electrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (5.6)
• •
  Refeeding Syndrome: Monitory laboratory parameters. (5.7)

• •
  Only for intravenous infusion. (2.1)
• •
  Infusion rate depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. (2.1, 2.2, 2.3)

Injection:

• •
  5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible plastic ADD-Vantage^TM diluent containers: 50 mL, 100 mL and 250 mL.

This dextrose product is intended to be used as a diluent for the contents of an ADD- Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR^TM.

The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1)]. If thrombophlebitis develops, remove the catheter as soon as possible.

Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. (8.4)

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

Dextrose Injection, USP (5%) is a clear, colorless, sterile solution of dextrose supplied in single-dose flexible plastic ADD-Vantage^TM diluent containers. This dosage form is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with a 20 mm closure using the ADD-Vantage ADDAPTOR^TM.

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

Use the product immediately after the introduction of additives.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Do not freeze.

To contact Pfizer’s Medical Information Department, please visit www.pfizermedinfo.com or call 1‑800-438‑1985.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1143-4.0

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

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

• •
  Use a non-vented infusion set or close the vent on a vented set.
• •
  Use a dedicated line without any connections (do not connect flexible containers in series).
• •
  Do not pressurize the flexible container to increase flow rates.
• •
  If using a pumping device to administer Dextrose Injection (5%), turn off the pump before the container is empty.

To Open:

• •
  Peel overwrap at corner and remove solution container.
  • o
    Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date.
• •
  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.

To Assemble Vial and Flexible Diluent Container:

Preparation for Administration:

• 1.
  Confirm the activation and admixture of vial contents.
• 2.
  Check for leaks by squeezing the container firmly. If leaks are found, discard the unit because sterility may be compromised.
• 3.
  Close the flow control clamp of the administration set.
• 4.
  Remove the cover from the outlet port at the bottom of the container.
• 5.
  Insert the piercing pin of the administration set into the port with a twisting motion until the pin is firmly seated. Note: See full directions on the administration set carton.
• 6.
  Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend the container from the hanger.
• 7.
  Squeeze and release the drip chamber to establish the proper fluid level in the chamber.
• 8.
  Open the flow control clamp and clear air from set. Close clamp.
• 9.
  Attach the set to the venipuncture device. If the device is not indwelling, prime and make venipuncture.
• 10.
  Regulate the rate of administration with the flow control clamp. Do not use the flexible container in series connections.

Dextrose Injection (5%) is intended for intravenous use.

• •
  Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.
• •
  To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4)].
• •
  Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
• •
  Use of a final filter is recommended during administration of parenteral solutions, where possible.
• •
  Discard the unused portion.
• •
  Do not use the Dextrose Injection (5%) ADD-Vantage^TM diluent containers with chemotherapy agents.

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-68

5% DEXTROSE

Injection, USP

50

mL

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE

OF POSSIBLE ROULEAU FORMATION. FOR USE ONLY

WITH ADD-Vantage™ SYSTEM COMPONENTS. SINGLE-

DOSE CONTAINER. FOR IV USE. USUAL DOSAGE: SEE

PACKAGE INSERT. STERILE, NONPYROGENIC. USE ONLY

IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Rx ONLY

IM-4480

14475201

3

v

CONTAINS DEHP

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-69

5% DEXTROSE

Injection, USP

100

mL

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF

POSSIBLE ROULEAU FORMATION. FOR USE ONLY WITH

ADD-Vantage™ SYSTEM COMPONENTS. SINGLE-DOSE

CONTAINER. FOR IV USE. USUAL DOSAGE: SEE PACKAGE

INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION

IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT

BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Rx ONLY

IM-4481

14475601

3

v

CONTAINS DEHP

LOT

EXP.

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-04

5% DEXTROSE

Injection, USP

250

mL

EACH 100 mL CONTAINS

DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc).

pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS

WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD

TRANSFUSIONS BECAUSE

OF POSSIBLE ROULEAU

FORMATION. FOR USE ONLY

WITH ADD-Vantage™ SYSTEM

COMPONENTS. SINGLE-

DOSE CONTAINER. FOR

INTRAVENOUS USE. USUAL

DOSAGE: SEE INSERT. STERILE,

NONPYROGENIC. USE ONLY

IF SOLUTION IS CLEAR AND

CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Hospira

3

v

CONTAINS DEHP

IM-4482

14475801

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

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

Avoid Dextrose Injection (5%) in patients at risk for fluid and/or solute overload. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and 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.

TO OPEN – PEEL AT NOTCH

Five/ADD-Vantage™ Units

For use only with ADD-Vantage™ system components.

The overwrap is a moisture barrier. Use units within 30 days of opening overwrap, as long as the use

date does not exceed the printed expiration date. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be

impaired. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Rx only

14475301

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

WR-0581

One/ADD-Vantage™ Unit

TO OPEN–PEEL AT CORNER

For use only with ADD-Vantage™ system components.

The overwrap is a moisture barrier. Use unit within 30 days of opening

overwrap, as long as the use date does not exceed the printed

expiration date. Store at 20 to 25°C (68 to 77°F). [See USP Controlled

Room Temperature.] Protect from freezing. See insert.

After removing the overwrap, check for minute leaks by

squeezing container firmly. If leaks are found, discard

unit as sterility may be impaired.

Rx only

14475901

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

WR-0583

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

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

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

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

Dextrose Injection (5%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.2, 5.5, 5.6)]. Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance.

Concomitant administration of Dextrose Injection (5%) 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%) 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)].

A medication error resulting in a high infusion rate of Dextrose Injection (5%) 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%) 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)].

Risk Summary

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

The background risk of major birth defects and miscarriage for the indicated populations are 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.

Risk Summary

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

Dextrose, USP is chemically designated D-glucose, monohydrate (C₆H₁₂O₆ • H₂O), a hexose sugar freely soluble in water.

The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)].

Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 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 supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5).

Dextrose is derived from corn.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

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

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

Neonates, especially preterm neonates 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%) 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 neonates, excessive or rapid administration of Dextrose Injection (5%) may increase the risk of intracerebral hemorrhage.

Dextrose Injection (5%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and 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 slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5%) 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 the infusion rate, and patients should be closely monitored during Dextrose Injection (5%) treatment.

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

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

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

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

The following adverse reactions associated with the use of Dextrose Injection (5%) were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

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

Cardiovascular disorders: cyanosis, volume overload

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

Dextrose is oxidized to carbon dioxide and water.

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.

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

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

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%) administration rate should be based on the patient’s tolerance of dextrose, especially for preterm neonates 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)].

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%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

• •
  Neonatal Hypoglycemia: Closely monitor blood glucose concentration to ensure adequate glycemic control. (5.1)
• •
  Hyperglycemia and Hyperosmolar Hyperglycemic State: Use with caution in patients with known subclinical or overt diabetes mellitus. (5.2)
• •
  Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. (5.3)
• •
  Phlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.1, 5.4)
• •
  Hyponatremia: Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. (5.5)
• •
  Electrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (5.6)
• •
  Refeeding Syndrome: Monitory laboratory parameters. (5.7)

• •
  Only for intravenous infusion. (2.1)
• •
  Infusion rate depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. (2.1, 2.2, 2.3)

Injection:

• •
  5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible plastic ADD-Vantage^TM diluent containers: 50 mL, 100 mL and 250 mL.

This dextrose product is intended to be used as a diluent for the contents of an ADD- Vantage vial or a single-dose powdered drug vial with 20 mm closure using the ADD-Vantage ADDAPTOR^TM.

The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1)]. If thrombophlebitis develops, remove the catheter as soon as possible.

Pediatric Use: Increased risk of hypoglycemia/hyperglycemia and imbalances in fluid/electrolytes; monitor serum glucose concentrations, volume status, and electrolytes. (8.4)

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

Dextrose Injection, USP (5%) is a clear, colorless, sterile solution of dextrose supplied in single-dose flexible plastic ADD-Vantage^TM diluent containers. This dosage form is intended to be used as a diluent for the contents of an ADD-Vantage vial or a single-dose powdered drug vial with a 20 mm closure using the ADD-Vantage ADDAPTOR^TM.

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

Use the product immediately after the introduction of additives.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Do not freeze.

To contact Pfizer’s Medical Information Department, please visit www.pfizermedinfo.com or call 1‑800-438‑1985.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1143-4.0

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

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

• •
  Use a non-vented infusion set or close the vent on a vented set.
• •
  Use a dedicated line without any connections (do not connect flexible containers in series).
• •
  Do not pressurize the flexible container to increase flow rates.
• •
  If using a pumping device to administer Dextrose Injection (5%), turn off the pump before the container is empty.

To Open:

• •
  Peel overwrap at corner and remove solution container.
  • o
    Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date.
• •
  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.

To Assemble Vial and Flexible Diluent Container:

Preparation for Administration:

• 1.
  Confirm the activation and admixture of vial contents.
• 2.
  Check for leaks by squeezing the container firmly. If leaks are found, discard the unit because sterility may be compromised.
• 3.
  Close the flow control clamp of the administration set.
• 4.
  Remove the cover from the outlet port at the bottom of the container.
• 5.
  Insert the piercing pin of the administration set into the port with a twisting motion until the pin is firmly seated. Note: See full directions on the administration set carton.
• 6.
  Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend the container from the hanger.
• 7.
  Squeeze and release the drip chamber to establish the proper fluid level in the chamber.
• 8.
  Open the flow control clamp and clear air from set. Close clamp.
• 9.
  Attach the set to the venipuncture device. If the device is not indwelling, prime and make venipuncture.
• 10.
  Regulate the rate of administration with the flow control clamp. Do not use the flexible container in series connections.

Dextrose Injection (5%) is intended for intravenous use.

• •
  Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.
• •
  To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4)].
• •
  Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
• •
  Use of a final filter is recommended during administration of parenteral solutions, where possible.
• •
  Discard the unused portion.
• •
  Do not use the Dextrose Injection (5%) ADD-Vantage^TM diluent containers with chemotherapy agents.

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-68

5% DEXTROSE

Injection, USP

50

mL

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE

OF POSSIBLE ROULEAU FORMATION. FOR USE ONLY

WITH ADD-Vantage™ SYSTEM COMPONENTS. SINGLE-

DOSE CONTAINER. FOR IV USE. USUAL DOSAGE: SEE

PACKAGE INSERT. STERILE, NONPYROGENIC. USE ONLY

IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Rx ONLY

IM-4480

14475201

3

v

CONTAINS DEHP

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-69

5% DEXTROSE

Injection, USP

100

mL

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc.). pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF

POSSIBLE ROULEAU FORMATION. FOR USE ONLY WITH

ADD-Vantage™ SYSTEM COMPONENTS. SINGLE-DOSE

CONTAINER. FOR IV USE. USUAL DOSAGE: SEE PACKAGE

INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION

IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT

BE USED IN SERIES CONNECTIONS.

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Rx ONLY

IM-4481

14475601

3

v

CONTAINS DEHP

LOT

EXP.

PULL INNER PLUG/STOPPER

AND MIX DRUG BEFORE USE

ADD-Vantage™ Unit

NDC 0409-7100-04

5% DEXTROSE

Injection, USP

250

mL

EACH 100 mL CONTAINS

DEXTROSE, HYDROUS 5 g.

253 mOsmol/LITER (calc).

pH 4.3 (3.2 TO 6.5)

DEXTROSE SOLUTIONS

WITHOUT SALTS SHOULD

NOT BE USED IN BLOOD

TRANSFUSIONS BECAUSE

OF POSSIBLE ROULEAU

FORMATION. FOR USE ONLY

WITH ADD-Vantage™ SYSTEM

COMPONENTS. SINGLE-

DOSE CONTAINER. FOR

INTRAVENOUS USE. USUAL

DOSAGE: SEE INSERT. STERILE,

NONPYROGENIC. USE ONLY

IF SOLUTION IS CLEAR AND

CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

DISTRIBUTED BY

HOSPIRA, INC.,

LAKE FOREST, IL 60045 USA

Hospira

3

v

CONTAINS DEHP

IM-4482

14475801

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

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

Avoid Dextrose Injection (5%) in patients at risk for fluid and/or solute overload. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and 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.

TO OPEN – PEEL AT NOTCH

Five/ADD-Vantage™ Units

For use only with ADD-Vantage™ system components.

The overwrap is a moisture barrier. Use units within 30 days of opening overwrap, as long as the use

date does not exceed the printed expiration date. After removing the overwrap, check for minute

leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be

impaired. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Rx only

14475301

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

WR-0581

One/ADD-Vantage™ Unit

TO OPEN–PEEL AT CORNER

For use only with ADD-Vantage™ system components.

The overwrap is a moisture barrier. Use unit within 30 days of opening

overwrap, as long as the use date does not exceed the printed

expiration date. Store at 20 to 25°C (68 to 77°F). [See USP Controlled

Room Temperature.] Protect from freezing. See insert.

After removing the overwrap, check for minute leaks by

squeezing container firmly. If leaks are found, discard

unit as sterility may be impaired.

Rx only

14475901

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

WR-0583

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

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

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

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

Dextrose Injection (5%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.2, 5.5, 5.6)]. Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance.

Concomitant administration of Dextrose Injection (5%) 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%) 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)].