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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.1 ) Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) Vein Damage and Thrombosis : Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. ( 2.2 , 5.3 ) Hyponatremia : Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 ) Electrolyte Imbalance and Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. ( 5.5 ) Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake. ( 5.6 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions 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 ( 5.5 )] . 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. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration. 5.2 Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions ( 6 )] . Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. 5.3 Vein Damage and Thrombosis Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administe...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions : anaphylaxis, pruritus, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions ( 5.2 )] Infusion Site Reactions : infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis [see Warnings and Precautions ( 5.3 )] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions ( 5.5 )] Refeeding syndrome [see Warnings and Precautions ( 5.6 )] Pulmonary vascular precipitates The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.