pharmacopeia
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/api/v1/drug/potassium-acetate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.

Indications

Sourced from openFDA
  • 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.ICD-10: E87.6

Contraindications

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

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

Potassium Acetate Injection (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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy Animal reproduction studies have not been conducted with potassium acetate. It is also not known whether potassium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium acetate should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

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 .)

Approval history

Sourced from openFDA
  • Aug 13, 1975NDANDA017610Otsuka Icu Medcl
  • Jul 20, 1984NDANDA018896Hospira
  • Dec 29, 2015ANDAANDA206203Exela Pharma
  • Nov 27, 2024ANDAANDA217515Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,894 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea1397.3%
  2. 2Nausea1327.0%
  3. 3Fatigue1296.8%
  4. 4Dyspnoea1216.4%
  5. 5Dizziness1055.5%
  6. 6Asthenia1005.3%
  7. 7Drug Ineffective975.1%
  8. 8Pain914.8%
  9. 9Headache884.6%
  10. 10Arthralgia743.9%
  11. 11Weight Decreased733.9%
  12. 12Fall703.7%
  13. 13Vomiting703.7%
  14. 14Pain In Extremity683.6%
  15. 15Death653.4%

Literature

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Recent PubMed references pinned to Potassium Acetate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 30 ClinicalTrials.gov registrations naming Potassium Acetate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Potassium Acetate work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.
What is Potassium Acetate used for?
According to FDA labeling, Potassium Acetate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Potassium Acetate?
Potassium Acetate is classified as Electrolyte solutions, Acid-Base Activity, Electrolyte Activity, Cellular Activity Alteration, Increased Insulin Secretion, Organized Electrical Activity Alteration.
What are the brand names for Potassium Acetate?
Potassium Acetate is marketed under brand names including Aminosyn 3.5 % M, Sulfite Free, Normosol-M, Nutrilyte, Nutrilyte II, Plasma-Lyte 56 in 5 % Dextrose.
What are the contraindications for Potassium Acetate?
Potassium Acetate labeling lists contraindications including: Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.. Always consult the full prescribing information and a clinician.
Note. Data for potassium-acetate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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