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. (1)

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Only for intravenous infusion. (2.1)

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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:

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5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in single-dose flexible plastic ADD-VantageTM 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 ADDAPTORTM. (3)

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Clinically significant hyperglycemia. (4)

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Known hypersensitivity to dextrose. (4)

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Neonatal Hypoglycemia: Closely monitor blood glucose concentration to ensure adequate glycemic control. (5.1)

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Hyperglycemia and Hyperosmolar Hyperglycemic State: Use with caution in patients with known subclinical or overt diabetes mellitus. (5.2)

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Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. (5.3)

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Phlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.1, 5.4)

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Hyponatremia: Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. (5.5)

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Electrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (5.6)

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Refeeding Syndrome: Monitory laboratory parameters. (5.7)

The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

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