Dextrose and Electrolyte No. 75

DEXTROSE AND ELECTROLYTE NO. 75- dextrose hydrous, sodium lactate, potassium chloride, sodium chloride and potassium phosphate, monobasic injection, solution
Baxter Healthcare Corporation

DESCRIPTION

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 220 mg Sodium Lactate (C3 H5 NaO3 ), 205 mg Potassium Chloride, USP (KCl), 120 mg Sodium Chloride, USP (NaCl), and 100 mg Monobasic Potassium Phosphate, NF (KH2 PO4 ). It contains no antimicrobial agents. pH 5.0 (4.0 to 6.5).

Image from Drug Label Content

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 40 mEq sodium, 35 mEq potassium, 48 mEq chloride, 20 mEq lactate, and 15 mEq phosphate as HPO4=. The osmolarity is 402 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) produce a metabolic alkalinizing effect. Lactate ions are metabolized in the liver to glycogen, and ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.

CONTRAINDICATIONS

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

5% Dextrose and Electrolyte No. 75 Injection (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 (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 (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) 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 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 (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

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