Get your patient on Potassium Acetate - Potassium Acetate injection, Solution, Concentrate (Potassium Acetate)
Potassium Acetate - Potassium Acetate injection, Solution, Concentrate prescribing information
INDICATIONS AND USAGE
Potassium Acetate Injection (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.
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.
CLINICAL PHARMACOLOGY
As the principal cation of the intracellular fluid, potassium plays an important role in fluid and electrolyte balance. The normal potassium concentration in the intracellular fluid compartment is about 160 mEq/liter. The normal serum potassium range is 3.5 to 5.0 mEq/liter. The kidney normally regulates potassium balance but does not conserve potassium as well or as promptly as it conserves sodium. The daily turnover of potassium in the normal adult averages 50 to 150 mEq (milliequivalents) and represents 1.5 to 5% of the total potassium content of the body.
Acetate (CH 3 COO − ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO 3 − ) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.
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:
| Product Code | Unit of Sale | Strength | Each |
| 510150 | NDC 65219-512-50 Unit of 25 | 100 mEq/50 mL (2 mEq/mL) | NDC 65219-512-02 50 mL Pharmacy Bulk Package Fliptop Vial |
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
The container closure is not made with natural rubber latex.
www.fresenius-kabi.com/us
451831
Issued: August 2024
