POTASSIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Hospira, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 10 meq in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance. Potassium Chloride Injection is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

Product summary:

Potassium Chloride Injection in flexible plastic containers is available as follows: NDC No. Potassium per container 0409–7074–26 10 mEq/100 mL 0409–7075–14 10 mEq/50 mL 0409–7075–26 20 mEq/100 mL 0409–7076–26 30 mEq/100 mL 0409–7077–14 20 mEq/50 mL 0409–7077–26 40 mEq/100 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Printed in USA Revised: April, 2009 EN-2079 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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POTASSIUM CHLORIDE INJECTION
For Use Only With A Calibrated Infusion Device
HIGHLY CONCENTRATED
Flexible Plastic Container
Ready To Use
R only
DESCRIPTION
This Potassium Chloride Injection is a sterile, nonpyrogenic, highly
concentrated, ready-to-use solution
of Potassium Chloride, USP in Water for Injection, USP for electrolyte
replenishment in a single dose
container for intravenous administration. It contains no antimicrobial
agents.
Potassium
Chloride
Injection
mEq Potassium/
Container
COMPOS ITION
(g/L)
Potassium
Chloride, USP
(KCl)
OS MOLARITY*
(MOS MOL/L)
(CALC)
PH
IONIC CONCENTRATION
(mEq/L)
POTAS S IUM Chloride
10 mEq/100 mL
7.45
200
5.8
(4.0 to 8.0)
100
100
10 mEq/50 mL
20 mEq/100 mL
14.9
400
5.8
(4.0 to 8.0)
200
200
30 mEq/100 mL
22.4
601
5.8
(4.0 to 8.0)
300
300
20 mEq/50 mL
40 mEq/100 mL
29.8
799
5.8
(4.0 to 8.0)
400
400
*Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L. Administration of
substantially hypertonic solutions (≥600 mOsmol/L) may cause vein
damage.
This flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Exposure to
temperatures above 25°C (77°F) during transport and storage will
lead to minor losses in moisture
content. Higher temperatures lead to greater losses. It is unlikely
that these minor losses will lead to
clinically significant changes within the expiration period. The
amount of water that can permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly. Solutions in
contact with the plastic container may leach out certain of its
chemical components from the plastic in
very small amounts; however, biological testing was supportive of the
safety of the plastic container
materials.
CLINICAL PHARMACOLOGY
Potassium is the major cation of body cells (160 mEq/liter of
intracellular water) and is concerned with
x
the maintenance of body fluid composition and electrolyte balance.
Potassium partic