Potassium Acetate

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Side Effects & Adverse Reactions

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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

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History

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Other Information

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 196.3 mg of potassium acetate which provides 2 mEq each of potassium (K+) and acetate (CH3COO-). 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 CH3COOK, 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.

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Potassium Acetate Manufacturers

Hospira, Inc.

Potassium Acetate | Hospira, Inc.

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 (CH3COO-).

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.

No Recall
American Regent, Inc.

Potassium Acetate | American Regent, Inc.

Potassium Acetate for Injection, USPCONCENTRATE(4 mEq/mL), must be diluted before administration. The dose and rate of injection are dependent upon the individual condition of each patient. ECG and serum potassium 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 of potassium (K+) with an equal number of milliequivalents of acetate (CH3COO-).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

No Recall
American Regent, Inc.

Potassium Acetate | American Regent, Inc.

Potassium Acetate Injection, USP (2 mEq/mL) must be diluted before administration.

The dose and rate of administration are dependent upon the individual condition of each patient. ECG and serum potassium 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 of potassium (K+) with an equal number of milliequivalents of acetate (CH3COO−).

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.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time the Pharmacy Bulk Package was initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

No Recall
Hospira, Inc.

Potassium Acetate | Hospira, Inc.

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 (CH3COO¯).

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.

No Recall
Hospira, Inc.

Potassium Acetate | Hospira, Inc.

Potassium Acetate Injection, USP, 40 mEq 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 (CH3COO−).

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.

No Recall
Hospira, Inc.

Potassium Acetate | Hospira, Inc.

Potassium Acetate Injection, USP, 40 mEq 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 (CH3COO-).

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.

No Recall