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Dextrose Electrolytes No 75

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Dextrose / Electrolytes No. 75

Warnings
Precautions

WARNINGS

5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, 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.

5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, 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.

5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate 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.

The intravenous administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) cancause 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 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3,USP) may result in sodium or potassium retention.

5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is not for use in the treatment of lactic acidosis.

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.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of 5% Dextrose and Electrolyte No.75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) to patients receiving corticosteroids or corticotropin. 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, 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 5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, USP). It is also not known whether 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type3,USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be given to apregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of dextrose and electrolytes 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.

Geriatric Use

Clinical studies of 5% Dextrose and Electrolyte No. 75 Injection (5% dextrose and electrolyte no. 75 inj) (Multiple Electrolytes and Dextrose Injection, Type 3, 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 other drug therapy.

Carcinogenesis, mutagenesis, impairment of fertility

Studies with 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, 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 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is administered to a nursing mother.

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

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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