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warnings and cautions
5 WARNINGS AND PRECAUTIONS Neonatal Hypoglycemia : Closely monitor blood glucose concentrations 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 : Monitor 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% and 10%) 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% and 10%) 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% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration. 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (5% and 10%) immediately if signs or symptoms...
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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neonatal Hypoglycemia [see Warnings and Precautions (5.1) ] Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Phlebitis and Thrombosis [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.6) ] Refeeding syndrome [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of Dextrose Injection (5% and 10%) were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, erythema, extravasation, pain, phlebitis, 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 or phlebitis, and electrolyte imbalance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.