Plasma-Lyte A (Page 2 of 3)

PRECAUTIONS

Patients with Renal Impairment

In patients with renal impairment, administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may result in sodium and/or potassium or magnesium retention (see WARNINGS). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention or magnesium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions

Other Products that Affect Fluid and/or Electrolyte Balance

Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Other Drugs that Increase the Risk of Hyponatremia

Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Lithium

Renal clearance of lithium may be increased during administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use.

Other Products that Increase the Risk of Hyperkalemia

Because of its potassium content, avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations.

Drugs with pH Dependent Renal Elimination

Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Drug/Laboratory Test Interactions

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions should be interpreted cautiously and confirmed by other diagnostic methods.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

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 PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is administered to a nursing mother.

Pediatric Use

The use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients is based on clinical practice.

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, 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. Consider monitoring renal function in elderly patients.

ADVERSE REACTIONS

Post-Marketing Adverse Reactions

The following adverse reactions associated with the use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Hypersensitivity and Infusion Reactions: tachycardia, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills.

General Disorders and Administration Site Conditions: infusion site pain, burning sensation.

Metabolism and nutrition disorders: hyperkalemia, hyponatremia.

Nervous System Disorders: hyponatremic encephalopathy.

Overdose

Excessive administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause:

fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.
hypernatremia and hyperkalemia, especially in patients with severe renal impairment.
hypermagnesemia. See WARNINGS and ADVERSE REACTIONS
metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations.

When assessing an overdose, any additives in the solution must also be considered.

The effects of an overdose may require immediate medical attention and treatment.

Interventions include discontinuation of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

DOSAGE AND ADMINISTRATION

Important Administration Instructions

PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is intended for intravenous administration using sterile equipment.
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
Use a dedicated line without any connections to avoid air embolism.
Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
PLASMA-LYTE A Injection pH 7.4 (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 A Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

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