5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State

Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (50%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness. To minimize these risks, slowly infuse Dextrose Injection (50%) and monitor blood and urine glucose during treatment with Dextrose Injection (50%).

If Dextrose Injection (50%) is abruptly discontinued, patients should receive 5% or 10% dextrose injection to avoid rebound hypoglycemia.

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (50%) administration [see Adverse Reactions (6)]. Stop administration of Dextrose Injection (50%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.3 Phlebitis and Thrombosis

Dextrose Injection (50%) is hypertonic (has an osmolarity greater than 900 mOsm/L) and may cause phlebitis and thrombosis at the site of injection. If thrombophlebitis occurs, remove the catheter as soon as possible.

Administer Dextrose Injection (50%) via slow intravenous infusion into a central vein (when possible) to reduce the risk of phlebitis and thrombosis. Ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis occurs, stop administration of Dextrose Injection (50%) and initiate corrective measures. Avoid administration of Dextrose Injection (50%) into a peripheral vein in pediatric patients 2 to 11 years old. If central venous access cannot be obtained in these pediatric patients, consider using an alternative commercially available dextrose product with a lower concentration.

Do not administer Dextrose Injection (50%) subcutaneously or intramuscularly.

5.4 Electrolyte Imbalance and Fluid Overload

Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (50%).

Depending on the administered volume and the infusion rate, administration of Dextrose Injection (50%) can cause fluid overload including pulmonary edema.

Avoid Dextrose Injection (50%) 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.

5.5 Hyponatremia

Dextrose Injection (50%) 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 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) and Use in Specific Populations (8.4)].

Avoid Dextrose Injection (50%) 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 (5.4)].

5.6 Potential Aluminum Toxicity for Patients with Immature or Impaired Renal Function

Dextrose Injection (50%) contains up to 600 mcg/L of aluminum. Prolonged administration of Dextrose Injection (50%) may lead to toxic levels of aluminum in pediatric patients with immature renal function. Due to the potential for excessive aluminum exposure, Dextrose Injection (50%) is not approved for pediatric patients younger than 2 years of age. Parenteral aluminum exposure greater than 4 to 5 mcg/kg/day has been associated with central nervous system and bone toxicity in this age group.

Prolonged administration of Dextrose Injection (50%) may also lead to toxic levels of aluminum in adults and pediatric patients with renal impairment.