Dextrose

5 WARNINGS AND PRECAUTIONS • 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 ) 5.1 Neonatal Hypoglycemia 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. 5.2 Hyperglycemia and Hyperosmolar Hyperglycemic State 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. 5.3 Hypersensitivity Reactions 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. 5.4 Phlebitis and Thrombosis 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. 5.5 Hyponatremia 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) ] . 5.6 Electrolyte Imbalance and Fluid Overload 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. 5.7 Refeeding Syndrome 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.