Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 14.6% Sodium Chloride Injection, USP Additive Solution is supplied as the following: Unit of Sale Concentration Each NDC 0409-6657-73 Tray of 25 50 mEq/20 mL (2.5 mEq/mL) NDC 0409-6657-01 20 mL Single-dose Plastic Fliptop Vial NDC 0409-6660-75 Tray of 25 100 mEq/40 mL (2.5 mEq/mL) NDC 0409-6660-01 40 mL Single-dose Plastic Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1099-1.0 9/2017 Hospira logo; PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL Single-dose CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE 14.6% Sodium Chloride Injection, USP 50 mEq/20 mL (2.5 mEq/mL) PRINCIPAL DISPLAY PANEL - 20 mL Vial Label; PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE. 20 mL Single-dose NDC 0409-6657-73 Contains 25 of NDC 0409-6657-01 Rx only 14.6% Sodium Chloride Injection, USP 50 mEq/20 mL (2.5 mEq/mL) Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray; PRINCIPAL DISPLAY PANEL - 40 mL Vial Label 40 mL Single-dose CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE 14.6% Sodium Chloride Injection, USP 100 mEq/40 mL (2.5 mEq/mL) PRINCIPAL DISPLAY PANEL - 40 mL Vial Label; PRINCIPAL DISPLAY PANEL - 40 mL Vial Tray CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE. 40 mL Single-dose NDC 0409-6660-75 Contains 25 of NDC 0409-6660-01 Rx only 14.6% Sodium Chloride Injection, USP 100 mEq/40 mL (2.5 mEq/mL) Hospira PRINCIPAL DISPLAY PANEL - 40 mL Vial Tray
- HOW SUPPLIED 14.6% Sodium Chloride Injection, USP Additive Solution is supplied as the following: Unit of Sale Concentration Each NDC 0409-6657-73 Tray of 25 50 mEq/20 mL (2.5 mEq/mL) NDC 0409-6657-01 20 mL Single-dose Plastic Fliptop Vial NDC 0409-6660-75 Tray of 25 100 mEq/40 mL (2.5 mEq/mL) NDC 0409-6660-01 40 mL Single-dose Plastic Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1099-1.0 9/2017 Hospira logo
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL Single-dose CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE 14.6% Sodium Chloride Injection, USP 50 mEq/20 mL (2.5 mEq/mL) PRINCIPAL DISPLAY PANEL - 20 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE. 20 mL Single-dose NDC 0409-6657-73 Contains 25 of NDC 0409-6657-01 Rx only 14.6% Sodium Chloride Injection, USP 50 mEq/20 mL (2.5 mEq/mL) Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray
- PRINCIPAL DISPLAY PANEL - 40 mL Vial Label 40 mL Single-dose CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE 14.6% Sodium Chloride Injection, USP 100 mEq/40 mL (2.5 mEq/mL) PRINCIPAL DISPLAY PANEL - 40 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 40 mL Vial Tray CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE. 40 mL Single-dose NDC 0409-6660-75 Contains 25 of NDC 0409-6660-01 Rx only 14.6% Sodium Chloride Injection, USP 100 mEq/40 mL (2.5 mEq/mL) Hospira PRINCIPAL DISPLAY PANEL - 40 mL Vial Tray
Overview
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.
Indications & Usage
14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
Dosage & Administration
14.6% 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. All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)
Warnings & Precautions
WARNINGS 14.6% 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, 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 overload 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
14.6% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions
Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. (See WARNINGS and PRECAUTIONS .)
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.