Dextrose
Generic Name: dextrose
Brand Names:
Dextrose
11 DESCRIPTION Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes.
Overview
11 DESCRIPTION Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes.
Uses
1 INDICATIONS AND USAGE Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Must be diluted with compatible intravenous fluids or used as admixture, prior to administration. Not for direct intravenous infusion . ( 2.1 ) • Only for slow intravenous infusion only into a: ( 2.1 ) o Central vein , if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L o Peripheral vein , if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L • Individualize dosage based on the patient's clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally ( 2.2 ) • Discontinue infusion of concentrated dextrose solutions slowly and/or administer 5% dextrose ( 2.3 ) 2.1 Important Preparation and Administration Instructions Dextrose Injection is sup...
Side Effects
6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] .
Warnings
5 WARNINGS AND PRECAUTIONS • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur ( 5.2 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Patients with impaired renal function, and preterm infants, at higher risk. 4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use.
Frequently Asked Questions
What is Dextrose used for?▼
1 INDICATIONS AND USAGE Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )
What are the side effects of Dextrose?▼
6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] .
Can I take Dextrose during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
What are the important warnings for Dextrose?▼
5 WARNINGS AND PRECAUTIONS • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur ( 5.2 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Patients with impaired renal function, and preterm infants, at higher risk. 4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.