Potassium Acetate POTASSIUM ACETATE HOSPIRA, INC. FDA Approved 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.
FunFoxMeds bottle
Substance Potassium Acetate
Route
INTRAVENOUS
Applications
NDA018896

Drug Facts

Composition & Profile

Strengths
50 ml
Quantities
50 ml
Treats Conditions
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

Identifiers & Packaging

Container Type BOTTLE
UNII
M911911U02
Packaging

HOW SUPPLIED Potassium Acetate Injection, USP is a Pharmacy Bulk Package which provides multiple single doses for continuous admixture compounding procedures is supplied as follows: Unit of Sale Concentration Each NDC 0409-3294-51 100 mEq/50 mL NDC 0409-3294-61 Carton of 25 (2 mEq/mL) Glass Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0903-2.0 9/2017; PRINCIPAL DISPLAY PANEL - 50 mL Vial Label 50 mL K + Potassium Acetate Injection, USP 100 mEq/50 mL (2 mEq/mL) Pharmacy Bulk Package–Not for direct infusion. Must be diluted. For Intravenous use.* Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 50 mL Vial Label; PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray 50 mL Rx only NDC 0409-3294-51 Contains 25 of NDC 0409-3294-61 Potassium Acetate Injection, USP 100 mEq/50 mL (2 mEq/mL) Pharmacy Bulk Package–Not for Direct Infusion CAUTION: MUST BE DILUTED. FOR INTRAVENOUS USE.* Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray

Package Descriptions
  • HOW SUPPLIED Potassium Acetate Injection, USP is a Pharmacy Bulk Package which provides multiple single doses for continuous admixture compounding procedures is supplied as follows: Unit of Sale Concentration Each NDC 0409-3294-51 100 mEq/50 mL NDC 0409-3294-61 Carton of 25 (2 mEq/mL) Glass Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0903-2.0 9/2017
  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Label 50 mL K + Potassium Acetate Injection, USP 100 mEq/50 mL (2 mEq/mL) Pharmacy Bulk Package–Not for direct infusion. Must be diluted. For Intravenous use.* Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray 50 mL Rx only NDC 0409-3294-51 Contains 25 of NDC 0409-3294-61 Potassium Acetate Injection, USP 100 mEq/50 mL (2 mEq/mL) Pharmacy Bulk Package–Not for Direct Infusion CAUTION: MUST BE DILUTED. FOR INTRAVENOUS USE.* Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray

Overview

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.

Indications & 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 & 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.

Warnings & Precautions
WARNINGS Potassium Acetate Injection, USP (2 mEq/mL) must be diluted before use. To avoid potassium intoxication, infuse potassium-containing solutions slowly. Potassium replacement therapy should be monitored whenever possible by continuous or serial electrocardiography (ECG). Serum potassium levels are not necessarily dependable indicators of tissue potassium levels. Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium 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. 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

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 .)


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