Plasma-Lyte R Multiple Electrolytes Injectable Solution
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.
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 (C 2 H 3 NaO 2 •3H 2 O); 496 mg of Sodium Chloride, USP (NaCl); 89.6 mg of Sodium Lactate (C 3 H 5 NaO 3 ); 74.6 mg of Potassium Chloride, USP (KCl); 36.8 mg of Calcium Chloride, USP (CaCl 2 •2H 2 O); and 30.5 mg of Magnesium Chloride, USP (MgCl 2 •6H 2 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.
HOW SUPPLIED
PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) in VIAFLEX plastic containers is available as shown below: Code Size (mL) NDC 2B2504 1000 NDC 0338-0177-04 Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat.
It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.
GERIATRIC USE
Geriatric Use Clinical studies of PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, 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 drug therapy.
Do not administer unless solution is clear and seal is intact.
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.
PEDIATRIC USE
Pediatric Use Safety and effectiveness of PLASMA-LYTE R Injection (Multiple Electrolytes Injection, Type 2, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature.
The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.
PREGNANCY
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.
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.