POTASSIUM ACETATE

INDICATIONS AND USAGE Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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 AND ADMINISTRATION Potassium Acetate Injection, USP (2 mEq/mL) in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile nutrient admixtures. Potassium Acetate Injection, USP (2 mEq/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. ECG and serum potassium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of potassium (K + ) with an equal number of milliequivalents of acetate (CH 3 COO - ). Maximum infusion rate: The infusion rate should not exceed 1 mEq/kg/hr. Normal daily requirements: Newborn: 2–6 mEq/kg/24 hr. Children: 2–3 mEq/kg/24 hr. Adult: 40 – 80 mEq/24 hr. Intraosseous infusion can be an alternate route for drug administration when intravenous access is not readily available. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .) Directions for Dispensing From Pharmacy Bulk Package The Pharmacy Bulk Package is for use in the Pharmacy Admixtures Service only. For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 inch long adhesive portions. Adhere each end to the label on the bottle. The vials should be suspended as a unit in the laminar flow hood. A single entry through the vial closure should be made with a sterile dispensing set or transfer device. Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended as it may cause leakage and multiple entries will increase the potential of microbial and particulate contamination. The above process should be carried out under a laminar flow hood using aseptic technique. Discard any unused portion within 4 hours after initial closure entry.

CONTRAINDICATIONS Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

ADVERSE REACTIONS Adverse reactions involve the possibility of potassium intoxication. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. (See WARNINGS and PRECAUTIONS .) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium 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 196 mg of potassium acetate which provides 2 mEq each of potassium (K + ) and acetate (CH 3 COO - ). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K + ) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CH 3 COOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations.

OVERDOSAGE In the event of overdosage, discontinue infusion containing potassium acetate immediately and institute corrective therapy as indicated to reduce elevated serum potassium levels and restore acid-base balance if necessary. (See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS . )

HOW SUPPLIED Potassium Acetate Injection, USP is supplied as follows: Unit of Sale Concentration Each NDC 0409-8183-25 40 mEq/20 mL NDC 0409-8183-15 Tray of 25 (2 mEq/mL) Single-Dose Fliptop Vial Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25oC (68 to 77oF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-0902-4.0 Revised: 11/2020 Logo