POTASSIUM ACETATE injection, solution, concentrate

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152)
Available from:
Hospira, Inc.
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, 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. 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 is supplied as follows: Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA N+ and NOVAPLUS are registered trademarks of Vizient, Inc. LAB-0902-2.0 9/2017
Authorization status:
New Drug Application
Authorization number:
0409-8183-15, 0409-8183-25

POTASSIUM ACETATE- potassium acetate injection, solution, concentrate

Hospira, Inc.

----------

Potassium Acetate Injection USP

POTASSIUM ACETATE

Injection, USP

40 mEq/20 mL (2 mEq/mL)

FOR ADDITIVE USE ONLY AFTER

DILUTION IN INTRAVENOUS FLUIDS

Plastic Vial

N+

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 (CH 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 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.

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 disease.

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.

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.

Pregnancy

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.

Pediatric Use: The safety and effectiveness of potassium acetate have been established in pediatric

patients.

Geriatric 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.

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.)

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. (See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.)

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 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.)

HOW SUPPLIED

Potassium Acetate Injection, USP is supplied as follows:

Unit of Sale

Concentration

Each

NDC 0409-8183-25

40 mEq/20 mL

NDC 0409-8183-15

Single-Dose Fliptop

Carton of 25

(2 mEq/mL)

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 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]

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

N+ and NOVAPLUS are registered trademarks of Vizient, Inc.

LAB-0902-2.0

9/2017

PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

NDC 0409-8183-15

20 mL Single-dose

Potas s ium

Acetate Injection, USP

K

40 mEq/20 mL (2 mEq/mL)

CAUTION: MUST BE DILUTED.

FOR INTRAVENOUS USE.

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray

NDC 0409-8183-25

Contains 25 of NDC 0409-8183-15

Rx only

+

20 mL Single-dose

POTASSIUM

ACETATE Injection, USP

40 mEq/20 mL (2 mEq/mL)

CAUTION:

MUST BE DILUTED.

FOR INTRAVENOUS USE.

POTASSIUM ACETATE

potassium acetate injection, solution, concentrate

Hospira, Inc.

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 40 9 -8 18 3

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO TASSIUM ACETATE (UNII: M9 119 11U0 2) (POTASSIUM CATION - UNII:29 5O53K152)

POTASSIUM ACETATE 3.9 3 g in 20 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ACETIC ACID (UNII: Q40 Q9 N0 6 3P)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 40 9 -8 18 3-

25 in 1 TRAY

0 3/27/20 14

1

NDC:0 40 9 -8 18 3-

20 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 8 9 6

0 3/27/20 14

Labeler -

Hospira, Inc. (141588017)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira, Inc.

0 9 31328 19

ANALYSIS(0 40 9 -8 18 3) , LABEL(0 40 9 -8 18 3) , MANUFACTURE(0 40 9 -8 18 3) , PACK(0 40 9 -8 18 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira, Inc.

8 277310 8 9

ANALYSIS(0 40 9 -8 18 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pfizer Healthcare India Private

Limite d

8 6 0 0 379 12

ANALYSIS(0 40 9 -8 18 3) , LABEL(0 40 9 -8 18 3) , MANUFACTURE(0 40 9 -8 18 3) ,

PACK(0 40 9 -8 18 3)

Revised: 12/2019

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