FDA label 3d33f2c3-fdfd-2c0d-e063-6394a90a0bfc

5 WARNINGS AND PRECAUTIONS 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 ) Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. ( 5.2 ) Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.3 ) Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. ( 5.4 ) Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) 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. 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (25%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness. To minimize these risks, slowly inject Dextrose Injection (25%) and monitor blood glucose levels before and after treatment with Dextrose Injection (25%). Due to the increased risk of hyperglycemia in neonates and low birth weight infants, use caution when selecting the dosage and injection rate of Dextrose Injection (25%). 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (25%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (25%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated. 5.3 Phlebitis and Thrombosis Dextrose Injection (25%) 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 (25%) via slow intravenous injection into a central vein 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 (25%) and initiate corrective measures. 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 (25%) 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 (25%). Depending on the administered volume and the infusion rate, administration of Dextrose Injection (25%) can cause fluid overload, including pulmonary edema. Avoid Dextrose Injection (25%) 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 (25%) 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, and 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 (25%) 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 Neonatal Adverse Reactions from Unapproved Maternal Use at Time of Delivery Dextrose Injection (25%) is not approved for use in adolescents or adults. Maternal hyperglycemia secondary to the use of concentrated dextrose solutions at the time of delivery has been associated with adverse outcomes such as neonatal hypoglycemia.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.1) ] . Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] . Phlebitis and Thrombosis [see Warnings and Precautions (5.3) ] Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload 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.