For IV Infusion After Dilution
Potassium Acetate Injection, USP is a sterile, non-pyrogenic, 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:
Potassium Acetate (Anhydrous) ........392 mg
(4 mmol or 4 mEq) Water for Injection, USP ....................q.s. pH (5.5 to 8.0) may have been adjusted with acetic acid. The formulation contains no bacteriostat, antimicrobial agent or added buffer.
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, colourless crystals or white crystalline powder very soluble in water.
Potassium Acetate Injection, USP is indicated as a source of potassium, for 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 AND ADMINISTRATION
Potassium Acetate Injection, USP 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 milli- equivalents of acetate (CH3COO–).
AVAILABILITY OF DOSAGE FORMS
|Product Number||Potassium Acetate Content(%)||K+ mmol/mL or mEq/mL||CH3COO– mmol/mL or mEq/mL||mOsmol/mL||Fill Volume mL|
Flip-top vials in boxes of 25.
Store between 15 and 30°C.Do not permit to freeze.
PHARMACEUTICAL PARTNERS OF CANADA, A Division of Abraxis BioScience, Inc. Richmond Hill, ON L4B 3P6. 1-877-821-7724. Rev 31 Jan 07. FDA Rev date: 12/24/2002
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.
Drug Abuse And Dependence
No information provided.
Potassium Acetate Injection,USP 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 ion 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.
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 µg per kg per day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of TPN products and of the lock-flush solutions used in their administration.
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.
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.
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.
Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.
As the principal cation of the intracellular fluid,potas-sium plays an important role in fluid and electrolyte balance.The normal potassium concentration in the intracellular fluid compartment is about 160 mEq/L. The normal serum potassium range is 3.5 to 5.0 mEq/L. 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 (milliequiva-lents) 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 meta- bolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.
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