DEXTROSE
Generic: DEXTROSE MONOHYDRATE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
0332f34a-7038-47cc-ba59-d55cad6b73ca
Indications & Usage
1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient or contraindicated.
Dextrose Injection is indicated as a source of calories when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated.
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Dextrose Injection is indicated as a source of calories when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated.
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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: • Pulmonary embolism due to pulmonary vascular precipitates [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) ] • Vein damage and thrombosis [see Warnings and Precautions (5.4) ] • H yponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] • Risk of infections [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, infection both systemic and at the injection site, and vein thrombosis or phlebitis.
( 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: • Pulmonary embolism due to pulmonary vascular precipitates [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) ] • Vein damage and thrombosis [see Warnings and Precautions (5.4) ] • H yponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] • Risk of infections [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, infection both systemic and at the injection site, and vein thrombosis or phlebitis.
( 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.