Physiolyte
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Physiolyte® (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
History
There is currently no drug history available for this drug.
Other Information
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 (CH3COO−) 27
Gluconate (HOCH2(CHOH)4COO−) 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 | CH3COONa•3H2O | 136.08 |
| Potassium Chloride USP | KCl | 74.55 |
| Magnesium Chloride Hexahydrate USP | MgCl2•6H2O | 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.
The PIC Container is PVC-free and DEHP-free.
Sources
Physiolyte Manufacturers
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B. Braun Medical Inc.
![Physiolyte (Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride) Irrigant [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Physiolyte | B. Braun Medical Inc.
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.
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