Dextrose Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration.
WARNING: Dextrose Injection USP contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Prolonged infusion of isotonic or hypotonic dextrose in water may increase the volume of extracellular fluid and cause water intoxication.
Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration.
Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.
There is currently no drug history available for this drug.
Each 100 mL of 5% Dextrose Injection USP contains:
Hydrous Dextrose USP 5 g; Water for Injection USP qs
pH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/liter
Calories per liter: 170
Each 100 mL of 10% Dextrose Injection USP contains:
Hydrous Dextrose USP 10 g; Water for Injection USP qs
pH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonic
Calories per liter: 340
Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration.
The formula of the active ingredient is:
|Ingredient||Molecular Formula||Molecular Weight|
|Hydrous Dextrose USP||198.17|
The EXCEL Container is Latex-free; PVC-free; and DEHP-free.
The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic technique.
The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.