DEXTROSE
Generic: DEXTROSE MONOHYDRATE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
3bb406a9-f5cb-403a-b1bb-5c4facbea3d5
Indications & Usage
1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories.
Dextrose Injection is indicated as a source of water and calories.
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Dextrose Injection is indicated as a source of water and calories.
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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, 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, and infusion site thrombophlebitis (10% dextrose only) [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 (10% dextrose only) 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.
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, and infusion site thrombophlebitis (10% dextrose only) [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 (10% dextrose only) 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.