Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX Plastic Container

Generic Name: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
Dosage Form: injection

Plasma-Lyte 148 Injection (Multiple Electrolytes 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 294 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 21 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.

Plasma-Lyte 148 - Clinical Pharmacology

Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, 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 148 Injection (Multiple Electrolytes 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 for Plasma-Lyte 148

Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.

Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. Plasma-Lyte 148 Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

Contraindications

None known

Warnings

Plasma-Lyte 148 Injection (Multiple Electrolytes 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 Injection (Multiple Electrolytes 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 Injection (Multiple Electrolytes 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 Injection (Multiple Electrolytes 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 Injection (Multiple Electrolytes 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 148 Injection (Multiple Electrolytes 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 Injection (Multiple Electrolytes Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Pregnancy

Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Plasma-Lyte 148 Dosage and Administration

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.