SODIUM CHLORIDE

INDICATIONS AND USAGE 23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an additive for total parenteral nutrition (TPN) and as an additive for carbohydrate containing I.V. fluids.

DOSAGE AND ADMINISTRATION 23.4% Sodium Chloride Injection, USP Additive Solution is administered intravenously only after addition to a larger volume of fluid. The dose, dilution and rate of injection are dependent upon the individual needs of each patient. In solutions for total parenteral nutrition (TPN), 120 mEq of sodium/day (range: 75–180 mEq/day) is the recommended adult dosage, whereas the recommended dosage is 3–4 mEq/kg/day for preterm infants. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion. Additives may be incompatible with the fluid dispensed from this container. Consult with pharmacist, if available. When admixing, use aseptic technique, mix thoroughly and do not store. Directions for Proper Use of Pharmacy Bulk Package Use Aseptic Technique 1. For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 in. long adhesive portions. Adhere each end to the label on the bottle. 2. During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. 3. Remove cover from container and cleanse closure with antiseptic. 4. Insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. The closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. 5. Sequentially dispense aliquots of 23.4% Sodium Chloride Injection, USP into intravenous containers using appropriate transfer device. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling. 6. Inspect solution after admixing. Discard if the solution is discolored or particulates are observed.

WARNINGS 23.4% Sodium Chloride Injection, USP is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, specifically osmotic demyelination syndrome, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly). Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium-free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

CONTRAINDICATIONS 23.4% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.

Pregnancy Animal reproduction studies have not been conducted with 23.4% Sodium Chloride Injection, USP. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers It is not known whether 23.4% Sodium Chloride Injection, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium chloride is administered to a nursing woman.

ADVERSE REACTIONS Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS .