Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old. (1)

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

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The recommended initial dose is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg). If clinically indicated, additional single doses of 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. (2.2)

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

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See full prescribing information for more information on preparation, administration instructions, and dosing considerations. (2.1, 2.2)

Injection:

 

25% (2.5 g/10 mL) (250 mg/mL) of dextrose hydrous in a clear, colorless solution in a single-dose Ansyr™ Plastic Syringe. (3)

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Intracranial or intraspinal hemorrhage. (4)

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Severe dehydration. (4)

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Hypersensitivity to dextrose. (4)

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Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose levels before and after treatment. Use caution when selecting the dosage and injection rate due to the increased risk of hyperglycemia in neonates and low birth weight infants. (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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Neonatal Adverse Reactions from Unapproved Maternal Use at Time of Delivery: Maternal hyperglycemia at the time of delivery has been associated with adverse outcomes such as neonatal hypoglycemia.

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.