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Dextrose 5 in .9 Sodium Chloride

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Dextrose 5% in 0.9% Sodium Chloride

WARNINGS

Dextrose and Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

Dextrose injections with low electrolyte concentrations should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood.

The intravenous administration of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional 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 and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) may result in significant hypokalemia.

In patients with diminished renal function, administration of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) may result in sodium retention.

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.

Caution must be exercised in the administration of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) to patients receiving corticosteroids or corticotropin.

Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) 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 and Sodium Chloride Injection, USP. It is also not known whether Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) in pediatric patients have not been established by adequate and well controlled trials, however, the use of dextrose and sodium chloride solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible hemorrhage.

Carcinogenesis, mutagenesis, impairment of fertility

Studies with Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) is administered to a nursing mother.

Geriatric Use

Clinical studies of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) 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 other drug therapy. Do not administer unless solution is clear and seal is intact.

Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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