POTASSIUM ACETATE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Exela Pharma Sciences, LLC

INN (International Name):

POTASSIUM ACETATE

Composition:

POTASSIUM ACETATE 3.93 g in 20 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Acetate Injection, USP 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. Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

Product summary:

Potassium Acetate Injection, USP, 40 mEq (2 mEq/mL) of K+ is supplied in a carton of 25, 20 mL partial-fill single-dose fliptop glass vials. Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the I.V. container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October 2015 Exela Pharma Sciences, LLC. Lenoir, NC 28645 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM ACETATE- POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
EXELA PHARMA SCIENCES, LLC
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POTASSIUM ACETATE INJECTION USP
POTASSIUM ACETATE INJECTION, USP
40 MEQ IN 20 ML
(2 MEQ K+ AND 2 MEQ CH COO /ML)
FOR ADDITIVE USE ONLY AFTER DILUTION IN INTRAVENOUS FLUIDS
USP TYPE I GLASS VIAL
RX ONLY
DESCRIPTION
Potassium Acetate Injection, USP, 40 mEq (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 20 mL vial contains 3.93 g of potassium acetate which provides 40
mEq each of potassium (K+)
and acetate (CH3COO ). It contains no bacteriostat, antimicrobial
agent or added buffer. May contain
acetic acid for pH adjustment. pH 6.2 (5.5 to 8.0). The osmolar
concentration is 4 mOsmol/mL (calc.).
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 CH COOK, colorless
crystals or white crystalline
powder very soluble in water.
The vial is fabricated from USP Type I glass.
CLINICAL PHARMACOLOGY
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 (CH COO ), a source of hydrogen ion acceptors, is an alternate
source of bicarbonate (HCO )
by metabolic conversion in the liver. This has been shown to proceed
readily, even in the presence of
severe liver