displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sodium Acetate for Injection, USP CONCENTRATE, 4 mEq/mL, is a sterile, nonpyrogenic, concentrated solution of Sodium Acetate (C2H3NaO2) in Water for Injection. It must be diluted prior to administration.
Each 50 mL vial contains 16.4 grams of Sodium Acetate (anhydrous) which provides 200 mEq each of Sodium (Na+) and Acetate (CH3COO–).
The pH is adjusted with acetic acid and the solution contains no bacteriostatic agent or other preservative.
The solution is intended as an alternative to Sodium Chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Unused portion should be discarded.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Sodium is the principal cation of extracellular fluids. The sodium ion exerts a primary role in controlling total body water and its distribution. The acetate ion is completely metabolized in the body, providing a source of hydrogen ion acceptors.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sodium Acetate for Injection, USP CONCENTRATE is indicated as a source of sodium in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas, when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Sodium Acetate for Injection, USP CONCENTRATE is contraindicated in patients with HYPERNATREMIA.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Sodium Acetate for Injection, USP CONCENTRATE must be diluted before use. To avoid sodium overload and water retention, infuse sodium containing solutions slowly. Do not use unless solution is clear and seal is intact.
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.
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Sodium replacement therapy should be guided primarily by serum sodium level. Use with caution in patients with renal impairment, cirrhosis, cardiac failure or other edematous or sodium retaining states.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing compounds. See WARNINGS.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Sodium Acetate for Injection, USP CONCENTRATE (4 mEq/mL), is administered intravenously only after dilution.
The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluids to provide the desired number of milliequivalents (mEq) of sodium (Na+) with an equal number of milliequivalents of acetate (CH3COO–).
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sodium Acetate for Injection, USP CONCENTRATE (4 mEq /mL)
NDC 0517-5023-25 50 mL Single Dose Vial packed in boxes of 25
Store at 20° – 25°C (68° – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) (See USP Controlled Room Temperature).
SHIRLEY, NY 11967
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPLE DISPLAY PANEL – 50 mL Container
FOR INJECTION, USP
200 mEq/50 mL
50 mL SINGLE DOSE VIAL
FOR IV USE AFTER DILUTION
SHIRLEY, NY 11967