Plasma-Lyte 148 and Dextrose

PLASMA-LYTE 148 AND DEXTROSE- dextrose hydrous, sodium chloride, potassium chloride, magnesium chloride, sodium gluconate and sodium acetate injection, solution
Baxter Healthcare Corporation

DESCRIPTION

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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*, 526 mg Sodium Chloride, USP (NaCl); 502 mg Sodium Gluconate (C6 H11 NaO7 ); 368 mg Sodium Acetate Trihydrate, USP (C2 H3 NaO2 •3H2 O), 37 mg Potassium Chloride, USP (KCl); and 30 mg Magnesium Chloride, USP (MgCl2 •6H2 O). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5). The pH is adjusted with hydrochloric acid.

Image from Drug Label Content

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate and 23 mEq gluconate. The osmolarity is 547 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 190 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 may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

CLINICAL PHARMACOLOGY

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) produces a metabolic alkalinizing effect. Acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, 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

Plasma-Lyte® 148 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® 148 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® 148 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 or gluconate 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 Plasma-Lyte® 148 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® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may result in sodium or potassium retention.

GENERAL 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® 148 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® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Plasma-Lyte® 148 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® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). It is also not known whether Plasma-Lyte® 148 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® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

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