Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Acetate Injection, USP is packaged in a pharmacy bulk package vial, 20 vials per tray, and is available as follows: Product No. NDC No. Sodium Acetate Content (%) Na + (sodium) mEq/mL CH 3 COO - (acetate) mEq/mL mOsmol/mL Fill Vol. (mL) 322100 63323-032-00 32.8 4 4 8 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451406 Issued: December 2017 Figure; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label NDC 63323-032-04 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION CAUTION: MUST BE DILUTED For Intravenous Use Only 100 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label NDC 63323-032-00 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION For Intravenous Use Only 20 (1 x 20) 100 mL Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label
- HOW SUPPLIED: Sodium Acetate Injection, USP is packaged in a pharmacy bulk package vial, 20 vials per tray, and is available as follows: Product No. NDC No. Sodium Acetate Content (%) Na + (sodium) mEq/mL CH 3 COO - (acetate) mEq/mL mOsmol/mL Fill Vol. (mL) 322100 63323-032-00 32.8 4 4 8 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451406 Issued: December 2017 Figure
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label NDC 63323-032-04 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION CAUTION: MUST BE DILUTED For Intravenous Use Only 100 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label NDC 63323-032-00 Sodium Acetate Injection, USP 400 mEq per 100 mL (4 mEq per mL) PHARMACY BULK PACKAGE– NOT FOR DIRECT INFUSION For Intravenous Use Only 20 (1 x 20) 100 mL Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Acetate 400 mEq per 100 mL Tray Label
Overview
Sodium Acetate Injection, USP (4 mEq per mL) is a sterile, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: 328 mg sodium acetate (anhydrous) which provides 4 mEq each of sodium (Na + ) and acetate (CH 3 COO - ). The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH may have been adjusted with glacial acetic acid to 6.5 (6.0 to 7.0). The osmolar concentration is 8 mOsmol/mL (calc); specific gravity 1.1511. 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. Sodium acetate, USP anhydrous is chemically designated as CH 3 COONa, a hygroscopic powder very soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
Indications & Usage
: Sodium Acetate Injection, USP (4 mEq per mL) 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.
Dosage & Administration
: Sodium Acetate Injection, USP (4 mEq per mL) is administered intravenously only after dilution in a larger volume of fluid. 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. Using aseptic technique, transfer the desired amount to other intravenous fluids to provide the appropriate number of milliequivalents (mEq) of sodium acetate. Sodium Acetate Injection, USP (4 mEq per mL) in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours after compounding. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see PRECAUTIONS ). Directions for Dispensing from Pharmacy Bulk Package The Pharmacy Bulk Package is for use in the Pharmacy Admixture Service only in a laminar flow hood. It should be inserted into the ring sling (plastic hanging device) provided and suspended as a unit in the laminar flow hood. The container closure should be penetrated only one time utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Swab vial stopper with an antiseptic solution. Insert the dispensing set into the vial using aseptic technique (see graphic illustration below ). Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. Discard the container no later than 4 hours after initial closure puncture. Do not administer unless solution is clear and seal is intact. Figure
Warnings & Precautions
WARNINGS: Sodium Acetate Injection, USP (4 mEq per mL) must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. 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 ions may result in sodium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading 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
: Sodium Acetate Injection, USP (4 mEq per mL) 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 ).
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