PHYSIOLYTE

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 (CH 3 COO − ) 27 Gluconate (HOCH 2 (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 CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Sodium Gluconate USP 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. Chemical Structure

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

As required for irrigation. The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

Physiolyte is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).