Get your patient on Potassium Acetate - Potassium Acetate injection, Solution, Concentrate (Potassium Acetate)

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Potassium Acetate - Potassium Acetate injection, Solution, Concentrate prescribing information

Indications & Usage

INDICATIONS AND USAGE

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.

Dosage & Administration

DOSAGE AND ADMINISTRATION

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 (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 .)

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 .)

Description

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 (CH 3 COO ). 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 3 COOK, 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.

Pharmacology

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 3 COO ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO 3 ) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.

How Supplied/Storage & Handling

HOW SUPPLIED

Potassium Acetate Injection, USP is supplied as follows:

Unit of Sale Concentration Each

NDC 0409-8183-01
Carton of 25

40 mEq/20 mL
(2 mEq/mL)

NDC 0409-8183-11
Single-Dose Fliptop Vial

Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Referenced Image

LAB-0901-2.0

9/2017

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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