Potassium Acetate 200 meq/100mL
Potassium Acetate · INJECTION · Exela Pharma Sciences, LLC
Potassium Acetate is a injection containing potassium acetate at 200 meq/100mL, taken intravenous. Manufactured by Exela Pharma Sciences, LLC.
Key Facts
- Brand Name
- Potassium Acetate
- Generic Name
- Potassium Acetate
- NDC Code (Product)
51754-2004- Manufacturer
- Exela Pharma Sciences, LLC
- Strength
- 200 meq/100mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206203
- Marketing Start
- 08/01/2023
Recall History
Exela Pharma Sciences LLC
Short Fill
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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, wheneve…
Warnings
WARNINGS 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…
Contraindications
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 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.
Frequently Asked Questions
What is Potassium Acetate used for?
Potassium Acetate contains Potassium Acetate. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Potassium Acetate a controlled substance?
Potassium Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Potassium Acetate?
The generic name for Potassium Acetate is Potassium Acetate. There are 1 other brand versions of Potassium Acetate.
What is the NDC code for Potassium Acetate 200 meq/100mL?
The NDC (National Drug Code) for Potassium Acetate 200 meq/100mL is 51754-2004, listed by Exela Pharma Sciences, LLC.