Plasma-Lyte R

PLASMA-LYTE R- sodium chloride, potassium chloride, magnesium chloride, sodium acetate trihydrate, sodium lactate and calcium chloride injection, solution
Baxter Healthcare Corporation

DESCRIPTION

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 640 mg of Sodium Acetate Trihydrate, USP (C2 H3 NaO2 •3H2 O); 496 mg of Sodium Chloride, USP (NaCl); 89.6 mg of Sodium Lactate (C3 H5 NaO3 ); 74.6 mg of Potassium Chloride, USP (KCl); 36.8 mg of Calcium Chloride, USP (CaCl2 •2H2 O); and 30.5 mg of Magnesium Chloride, USP (MgCl2 •6H2 O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0).

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 10 mEq potassium, 5 mEq calcium, 3 mEq magnesium, 103 mEq chloride, 47 mEq acetate, and 8 mEq lactate. The osmolarity is 312 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions may cause vein damage. The caloric content is 11 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

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) produces a metabolic alkalinizing effect. Acetate and lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.

CONTRAINDICATIONS

None known

WARNINGS

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, 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 R Injection (Multiple Electrolytes Injection, Type 2, 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 R Injection (Multiple Electrolytes Injection, Type 2, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate or 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 R Injection (Multiple Electrolytes Injection, Type 2, USP) should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.

The intravenous administration of PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, 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 R Injection (Multiple Electrolytes Injection, Type 2, USP) may result in sodium or potassium retention. PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, 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.

PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) to patients receiving corticosteroids or corticotropin.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP). It is also not known whether PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) should be given to a pregnant woman only if clearly needed.

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