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Dextrose

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Dextrose Injection 5%

WARNINGS

Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Excessive administration of dextrose (hydrous dextrose (hydrous dextrose) ) injections may result in significant hypokalemia.

In very low birth weight infants, excessive or rapid administration of dextrose (hydrous dextrose (hydrous dextrose) ) injection may result in increased serum osmolality and possible intracerebral hemorrhage.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Dextrose Injection, USP. It is also not known whether Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use

Dextrose (hydrous dextrose (hydrous dextrose) ) is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose (hydrous dextrose (hydrous dextrose) ) must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose (hydrous dextrose (hydrous dextrose) ) is prescribed to pediatric patients, particularly neonates and low birth weight infants.

Geriatric Use

Clinical studies of Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Do not administer unless solution is clear and seal is intact.

Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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