Physiosol Irrigation

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

Each 100 mL of PhysioSol™ Irrigation contains sodium chloride 526 mg, sodium acetate 222 mg, sodium gluconate 502 mg, potassium chloride 37 mg, magnesium chloride hexahydrate 30 mg. The pH is 6.0 (5.0 to 6.5) adjusted with hydrochloric acid. The solution is isotonic (294 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na+ 140, K+ 5, Mg++ 3, Cl− 98, HCO3− 50 alternates (27 as acetate and 23 as gluconate).

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

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

Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl2 • 6H2O), colorless, odorless flakes or crystals very soluble in water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Sodium Acetate, USP is chemically designated sodium acetate (C2H3O2Na), colorless crystals or white crystalline powder or flakes very soluble in water. It has the following structural formula:

Sodium gluconate is chemically designated C6H11NaO7, the normal sodium salt of gluconic acid soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentrations.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

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

Caution should be observed when a 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.

Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.

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 semi-rigid wide mouth container. When used for irrigation via 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.

Do not administer unless solution is clear, seal is intact, and container is undamaged. Discard unused portion.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with PhysioSol™ Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers:

Caution should be exercised when PhysioSol™ Irrigation is administered to a nursing woman.

Pregnancy:

Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with PhysioSol™ Irrigation. It is also not known whether PhysioSol™ Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PhysioSol™ Irrigation should be given to a pregnant woman only if clearly needed.

Pediatric Use:

The safety and effectiveness of PhysioSol™ Irrigation pH 7.4 have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use:

Clinical studies of PhysioSol™ Irrigation have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Consult your pharmacist.

How to use Physiosol Solution, Irrigation

Consult your pharmacist.