SODIUM ACETATE- sodium acetate anhydrous injection, solution, concentrate
American Regent, Inc.
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.
2 mEq/mL
4 mOsmol/mL
Rx Only
100 mL PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
DESCRIPTION
Sodium Acetate Injection, USP, 2 mEq/mL, is a sterile, nonpyrogenic solution of Sodium Acetate (C2 H3 NaO2 ) in Water for Injection. It must be diluted prior to administration.
Each mL contains Sodium Acetate (Anhydrous) 164 mg (equivalent to 2 mEq/mL), Water for Injection q.s. pH may be adjusted with Acetic Acid. Contains no bacteriostatic agent or other preservatives.
CLINICAL PHARMACOLOGY
Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/L. The sodium ion exerts a primary role in controlling total body water and its distribution.
Acetate (CH3 COO�), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO3 �) formed by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.
INDICATIONS AND USAGE
Sodium Acetate Injection, USP, is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia 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.
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.
CONTRAINDICATIONS
Sodium Acetate Injection, USP, is contraindicated in patients with hypernatremia or fluid retention
DOSAGE AND ADMINISTRATION
Sodium Acetate Injection, USP (2 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(CH3 COO�).
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Discard vial within 4 hours of initial entry.
