23.4% (4 mEq per mL)
8 mOsmol/mL

Rx Only

DESCRIPTION

Concentrated Sodium Chloride Injection, USP 23.4% is sterile, preservative free, nonpyrogenic, solution of Sodium Chloride in water for injection. Each mL contains: Sodium Chloride 234 mg (4 milliequivalents), Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. It is intended for dilution use only.

(1 mL diluted with 25 mL of Water for Injection will give approximately 308 mOsmol/mL).

Unused amount of the 30 mL Single Dose Vial should be discarded immediately following withdrawal of any portion of contents.

The 100 mL Pharmacy Bulk Package contains many single doses for use in a pharmacy admixture program in the preparation of parenteral fluids.

CLINICAL PHARMACOLOGY

Sodium Chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. Sodium (Na+) is the principle cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Concentrated 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 requirement of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, determine the appropriate number of milliequivalents of Concentrated Sodium Chloride Injection, USP and dilute for use.

CONTRAINDICATIONS

None known.

WARNINGS

Concentrated Sodium Chloride Injection, USP is hypertonic, and must be diluted before use. Inadvertent direct injection or absorption of Concentrated Sodium Chloride Injection, USP may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly). Do not use unless solution is clear. No preservative added.

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.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION

Concentrated Sodium Chloride Injection, USP is Strongly Hypertonic And Must Be Diluted Prior To Administration (See WARNINGS). The dosage of Concentrated Sodium Chloride Injection, USP as an additive in parenteral fluid therapy is predicated on the specific requirement of the patient after necessary clinical and laboratory information is considered and correlated. The appropriate volume is then withdrawn for proper dilution. Having determined the milliequivalents of Sodium Chloride to be added, divide by four to calculate the number of milliliters (mL) of concentrated solution to be used. Withdraw this volume aseptically and transfer this additive solution into appropriate intravenous solutions such as 5% dextrose injection. The properly diluted solutions may be given intravenously or subcutaneously.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use only if solution is clear and seal intact.

HOW SUPPLIED

Concentrated Sodium Chloride Injection, USP 23.4% (4 mEq per mL). No preservative added.

NDC 0517-2930-25             30 mL Single Dose Vials                          Packed in boxes of 25
NDC 0517-2900-25             100 mL Pharmacy Bulk Package              Packed in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN2930
Rev. 11/05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPLE DISPLAY PANEL – 30 mL Container

NCD 0517-2930-25

CONCENTRATED
SODIUM CHLORIDE
INJECTION, USP
23.4% (234 mg/mL)
4 mEq/mL

30 mL SINGLE DOSE VIAL

FOR IV OR SC USE
AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967