Dextrose
Generic: DEXTROSE MONOHYDRATE
Basic Information
Manufacturer
Becton Dickinson and Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8e7046f8-841e-465a-af69-af9fb3d6799d
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.
( 1 )
Dextrose Injection is indicated as a source of water and calories.
( 1 )
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, pruritus, 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 [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 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 Fresenius Kabi USA, LLC at 1-800-551-7176 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, pruritus, 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 [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 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.