Dextrose Injection (50%) is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older. (1)

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Only for intravenous infusion. Do not administer subcutaneous or intramuscularly. (2.1)

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Adults and Pediatric Patients 12 years of Age and Older

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Administer into a central vein or large peripheral vein.

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Recommended dosage is 10to 25 grams (20 to 50 mL) administered once. Repeated doses may be administered as clinically appropriate. (2.2)

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Pediatric Patients 2 to 11 Years of Age

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Administer into a central vein

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Appropriate dosage depends on the age, weight, clinical and metabolic conditions of the patient, and concomitant therapy. (2.2)

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Maximum rate of dextrose administration without producing hyperglycemia is o.5 g/kg of body weight/hour. (2.2)

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See full prescribing information for more information on preparation and administration instructions. (2.12.2)

Injection: 50% (25 g/50 mL) (500 mg/mL) of single-dose dextrose hydrous supplied as: (3)

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LifeShield® Abboject® Unit of Use Syringe with Male Luer Lock Adapter and protected needle

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Abboject® Syringe with Male Luer Lock Adapter

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Ansyr® II Plastic Syringe with syringe and barrel detached

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Fliptop Vials

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Intracranial or intraspinal hemorrhage. (4)

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Severe dehydration. (4)

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Alcohol withdrawal. (4)

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Known hypersensitivity to dextrose. (4)

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Hyperglycemia or Hyperosmolar Syndrome: Monitor blood and urine glucose; administer insulin as needed. (5.1)

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Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. (5.2)

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Phlebitis and Thrombosis: Remove catheter as soon as possible if thrombophlebitis develops. (2.1, 5.3)

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Electrolyte Imbalance and Fluid Overload: Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. (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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Potential Aluminum Toxicity for Patients with Immature or Impaired Renal Function: Prolonged administration of Dextrose Injection (50%) may lead to toxic levels of aluminum in pediatric patients with immature renal function or renal impairment, and in adults with renal impairment. (5.6)

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. Use a different dextrose product if treatment is necessary in a pediatric patient younger than 2 years old. (8.4)