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Plasma-Lyte 56

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Plasma-Lyte 56 and Dextrose

WARNINGS

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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 Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) 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 injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may result in sodium or potassium 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.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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 Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). It is also not known whether Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of plasmalyte and dextrose 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 and Mutagenesis and Impairment of Fertility

Studies with Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) 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 Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is administered to a nursing mother.

Geriatric Use

Clinical studies of Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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: 5/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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