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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, those irrigations must be regarded as a systemic drug. Absorption of large amounts 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Do not heat over 66°C (150°F).
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FDA Safety Alerts
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FDA Labeling Changes
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PhysioSol™ is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
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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.