FDA
Sodium Chloride 0.9% in Plastic Container
The FDA lists this product in 46 strengths and forms.
Indications
This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).
Contraindications
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings and precautions
FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, each of these 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).
Pregnancy and breastfeeding
Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.
Adverse reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable 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.



