Label: SODUM ACETATE- sodium acetate injection, solution, concentrate
- NDC Code(s): 0517-5023-25
- Packager: American Regent, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated January 20, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
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.
- CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
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.
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.
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.
Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing compounds. See WARNINGS.
DOSAGE AND ADMINISTRATION
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.
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- Serialization Label
INGREDIENTS AND APPEARANCE
sodium acetate injection, solution, concentrate
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-5023 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE ANHYDROUS 328 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-5023-25 25 in 1 TRAY 09/30/1990 1 50 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 09/30/1990 Labeler - American Regent, Inc. (002033710) Establishment Name Address ID/FEI Business Operations American Regent, Inc. 002033710 ANALYSIS(0517-5023) , MANUFACTURE(0517-5023)