Potassium Acetate Recall
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Questions & Answers
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
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.