FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Sodum Acetate Manufacturers
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American Regent, Inc.
Sodum Acetate | American Regent, Inc.
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.
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