Potassium acetate

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# Overview
Potassium acetate is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. that is FDA approved for the treatment of hypokalemia in patients with restricted or no oral intake.   Common adverse reactions include potassium intoxication (paresthesias of the extremities,listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block).

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- Potassium Acetate Injection, USP, 40 mEq 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
- 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.

### Dosage
- 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:
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Potassium acetate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Potassium acetate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Potassium acetate in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Potassium acetate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Potassium acetate in pediatric patients.

# Contraindications
- Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

# Warnings
- Potassium Acetate Injection, USP, 40 mEq 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.

### Precautions
- Do not administer unless solution is clear and seal is intact. Discard unused portion.
- Potassium replacement therapy should be guided primarily by ECG monitoring and secondarily by the serum potassium level.
- High plasma concentrations of potassium may cause death by cardiac depression, arrhythmias or arrest.
- Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.
- Solutions containing acetate ion should be used with caution as excess administration may result in metabolic alkalosis.

# Adverse Reactions

## Clinical Trials Experience
- 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.

## Postmarketing Experience
There is limited information regarding Potassium acetate Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Potassium acetate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- 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.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Potassium acetate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Potassium acetate during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Potassium acetate with respect to nursing mothers.

### Pediatric Use
- The safety and effectiveness of potassium acetate have been established in pediatric patients.

### Geriatic Use
- An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
- Potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

### Gender
There is no FDA guidance on the use of Potassium acetate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Potassium acetate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Potassium acetate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Potassium acetate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Potassium acetate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Potassium acetate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous
- 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).
- Intraosseous

### Monitoring
- ECG and serum potassium should be monitored as a guide to dosage.
- Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

# IV Compatibility
There is limited information regarding IV Compatibility of Potassium acetate in the drug label.

# Overdosage
- 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

# Pharmacology

## Mechanism of Action
- As the principal cation of the intracellular fluid, potassium plays an important role in fluid and electrolyte balance
- Acetate (CH3COO), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO3) by metabolic conversion in the liver.

## Structure
- Potassium acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.
- The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Potassium acetate in the drug label.

## Pharmacokinetics
- 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 (CH3COO), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO3) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Potassium acetate in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Potassium acetate in the drug label.

# How Supplied
- Potassium Acetate Injection, USP, 40 mEq (2 mEq/mL) of K+ is supplied in a 20 mL partial-fill single-dose fliptop vial (List 8183).
- Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the I.V. container.

## Storage
- Store at 20 to 25C (68 to 77F).

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Potassium acetate in the drug label.

# Precautions with Alcohol
- Alcohol-Potassium acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- POTASSIUM ACETATE

# Look-Alike Drug Names
There is limited information regarding Potassium acetate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price