dextrose 40% in plastic container
dextrose · by otsuka icu medcl
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Overview
Dextrose Injection 70%, USP is a clear, sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in Water for Injection in a flexible plastic container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program. Dextrose Injection is not for direct intravenous infusion [see Dosage and Administration (2.1) ] . The Pharmacy Bulk Package is designed to facilitate admixture or dilution to provide dextrose in various concentrations and is available in a 2000 mL size. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use following admixture or dilution. The pH range is 4.0 (3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 70%, USP Strength Fill Volume Amount of Dextrose Hydrous, USP per container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container Osmolarity (mOsmol per liter) (calc.) Dextrose Injection 70%, USP (0.7 grams/mL) 2000 mL 1400 grams 4760 3530 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H…
How to use
2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • For slow intravenous infusion only into a: ( 2.2 ) o Central vein, if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L approximately. o Peripheral vein, if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L approximately. • Individualize dosage based on the patient’s clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally. ( 2.3 ) • Discontinue infusion of concentrated dextrose solutions slowly. ( 2.4 ) 2.1 Preparation Instructions Prior to Administration Dextrose Injection is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion. Dextrose Injection is intended for use in the preparation of sterile, intravenous admixtures. Prior to administration, Dextrose Injection must be transferred to a separate PN container , diluted with other compatible intravenous fluids and used as an admixture in PN solutions. • Do not remove from overpouch until ready to use. • Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution…
Side effects
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…
Warnings
Important safety information
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.3 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity of approximately 900 mOsm/L or greater through a central vein. ( 2.2 , 5.4 ) • Hyponatremia: Monitor serum sodium to minimize the risk of hypo- or hyperosmotic hyponatremia. ( 5.5 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters. ( 5.6 ) • Refeeding Syndrome : Monitory laboratory parameters. ( 5.7 ) • Hepatobiliary Disorders : Monitor liver function parameters and ammonia levels. ( 5.8 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Adult patients with impaired renal function and preterm infants are at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.9 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function…
Interactions
Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.1 ) 7.1 Other Products that Affect Glycemic Control or Fluid and/or Electrolyte Balance Dextrose Injection can affect glycemic control and fluid and/or electrolyte balance [see Warnings and Precautions (5.2 , 5.5 , 5.11 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, or fluid and/or electrolyte balance (such as diuretics and anti-epileptics).
Drug class
Dosage forms
INJECTABLE
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Frequently asked questions
- What is Dextrose 40% In Plastic Container?
- Dextrose Injection 70%, USP is a clear, sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in Water for Injection in a flexible plastic container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program. Dextrose Injection is not for direct intravenous infusion [see Dosage and Administration (2.1) ] . The Pharmacy Bulk Package is designed to facilitate admixture or dilution to provide dextrose in various concentrations and is available in a 2000 mL size. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use following admixture or dilution. The pH range is 4.0 (3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 70%, USP Strength Fill Volume Amount of Dextrose Hydrous, USP per container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container Osmolarity (mOsmol per liter) (calc.) Dextrose Injection 70%, USP (0.7 grams/mL) 2000 mL 1400 grams 4760 3530 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H…
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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