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 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 [see Dosage and Administration ( 2.1 )] .The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops. 5.4 Hyponatremia Dextrose Injection is a hypertonic solution [see Description, Table 1 ( 11 )] . In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids. Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted. Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations ( 8.4 , 8.5 )] . Avoid Dextrose Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia. 5.5 Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Depending on the volume and rate of infusion, the patient's underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, (including hypoosmotic hyponatremia), overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution. Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and 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. Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations ( 8.4 , 8.5 )]. 5.6 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.