Physiolyte

PHYSIOLYTE- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride irrigant
B. Braun Medical Inc.

Balanced Electrolyte Solution for Irrigation.
For All General Irrigation, Washing, and Rinsing Purposes.
Not for Injection by Usual Parenteral Route.

DESCRIPTION

Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes.

Each 100 mL contains:
Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g
Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride
USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g
Water for Injection USP qs
Glacial Acetic Acid USP has been added to adjust the pH

pH: 6.8 (6.3–7.3)
Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter)

Concentration of Electrolytes (mEq/liter): Sodium 140
Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3 COO) 27Gluconate (HOCH2 (CHOH)4 COO) 23

It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.

The formulas of the active ingredients are:

Ingredients Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44
Sodium Acetate Trihydrate USP CH3 COONa•3H2 O 136.08
Potassium Chloride USP KCl 74.55
Magnesium Chloride Hexahydrate USP MgCl2 •6H2 O 203.30
Sodium Gluconate USPChemical Structure 218.14

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Not made with natural rubber latex, PVC or DEHP.

CLINICAL PHARMACOLOGY

Physiolyte exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.

Physiolyte provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Isolyte® S (Multi-Electrolyte Solution) a multiple electrolyte solution for IV replacement of acute extracellular fluid losses.

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular and cardiac conduction and irritability.

Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water, and serve as alkalinizing agents.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Physiolyte™ (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

CONTRAINDICATIONS

Physiolyte is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

WARNINGS

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations.

Do not warm above 150°F (66°C).

After opening container, it’s contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

PRECAUTIONS

General

Use aseptic technique when preparing and administering sterile irrigation solutions for irrigating body cavities, wounds and urethral catheters or for wetting dressings that come in contact with the body tissues. Use only if solution is clear and container and seal are intact.

Do not use for irrigation that may result in absorption of large amounts into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Physiolyte™ (A Physiological Irrigating Solution) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Physiolyte™ (A Physiological Irrigating Solution). It is also not known whether Physiolyte™ (A Physiological Irrigating Solution) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Physiolyte™ (A Physiological Irrigating Solution) should be given to a pregnant woman only if clearly needed.

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