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Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use

Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age.

Dextrose Injection (25%) can increase the risk of developing hypo- or hyperglycemia in neonates, especially preterm neonates with low birth weight. Excessive or rapid administration of Dextrose Injection (25%) may also result in increased serum osmolality and increase the risk of intracerebral hemorrhage in very low birth weight neonates [see Warnings and Precautions (5.1)].

Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients treated with Dextrose Injection (25%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4, 5.5)].

Dextrose Injection (25%) is not indicated in pediatric patients 2 years of age and older.

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