Sodium Chloride

INDICATIONS AND USAGE: Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. The toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect. Symptoms of sodium chloride deficiency are very similar to those of Addison's disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. Other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.

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.

CONTRAINDICATIONS: Surgical patients should seldom receive salt- containing solutions immediately following surgery unless factors producing salt depletion are present. Because of renal retention of salt during surgery, additional electrolyte given intravenously may result in fluid retention, edema and overloading of the circulation.

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Parenteral administration of quantities of sodium in excess of the amount of water or sodium chloride needed or at a rate more rapid than can be accommodated by the patient's circulatory function may result in edema and clinical findings resembling those of congestive heart failure. Adverse effects are particularly likely to develop in patients with impaired renal or cardiac function. Signs of postoperative salt intolerance include cellular dehydration, weakness, disorientation, anorexia, nausea, distention, deep respiration, oliguria and increased blood urea nitrogen.

DESCRIPTION 14.6% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either 2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Na + and Cl ̄ ) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 5 mOsmol/mL (calc.); specific gravity is 1.10. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

OVERDOSAGE: Administration of too much sodium chloride may result in serious electrolyte disturbances with resulting retention of water, edema, loss of potassium and aggravation of an existing acidosis. When intake of sodium chloride is excessive, excretion of crystalloids is increased in an attempt to maintain normal osmotic pressure. Thus there is increased excretion of potassium and of bicarbonate and, consequently, a tendency toward acidosis. There is also a rapid elimination of any foreign salt, such as iodide and bromide, being used for therapy.

How Supplied Sodium Chloride Injection, USP, 23.4% is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. The container closure is not made with natural rubber latex. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 63323-093-30 30 mL fill in a 50 mL Single-dose Plastic Fliptop Vial Unit of 25 NDC 0404-9978-30 1 30 mL Single-dose Plastic Fliptop Vial in a bag (Vial bears NDC 63323-093-01) 23.4% 120 mEq/30 mL (4 mEq/mL) image2.jpg