1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 13 mm or 20 mm closure.

Dextrose Injection is indicated as a source of calories and water and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 13 mm or 20 mm closure.

( 1 )

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, pruritis, 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 [see Warnings and Precautions (5.3) ] • Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.6) ] Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5) ] 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 Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.