POTASSIUM CHLORIDE injection, solution, concentrate

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 149 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. Potassium Chloride for Injection Concentrate, USP 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 for Injection Concentrate, USP, is supplied in single-dose containers as follows: NDC 0409-6635-01 Tray of 25 single-dose containers 10 mEq/5 mL (2 mEq/mL) NDC 0409-6636-01 Tray of 25 single-dose containers 30 mEq/15 mL (2 mEq/mL) NDC 0409-6651-06 Tray of 25 single-dose containers 20 mEq/10 mL (2 mEq/mL) NDC 0409-6653-05 Tray of 25 single-dose containers 40 mEq/20 mL (2 mEq/mL) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hospira Inc., Lake Forest, IL 60045 USA                                                                              LAB-1319-2.0 Revised: 10/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE INJECTION, SOLUTION,
CONCENTRATE
HOSPIRA, INC.
----------
POTASSIUM
CHLORIDE RX
ONLY
for Injection
CONCENTRATE, USP
CONCENTRATE
_MUST BE DILUTED BEFORE USE._
_FOR INTRAVENOUS INFUSION ONLY;_
_MUST BE DILUTED PRIOR TO INJECTION_.
FLIPTOP VIALS
_DESCRIPTION_
Potassium Chloride for Injection Concentrate, USP, is a sterile,
nonpyrogenic,
concentrated solution of potassium chloride, USP in water for
injection administered by
intravenous infusion only after dilution in a larger volume of fluid.
They are provided in
the following variety of concentrations and sizes comprising a choice
of single-dose
containers, all designed to provide the commonly prescribed amounts of
potassium
chloride for single-dose infusion after dilution in suitable large
volume parenterals.
*
ADDITIVE SOLUTION
(CONC. & SIZE)
K
MEQ/ML
KCL
MG/ML
MOSMOL/ML
(CALC.)
10 mEq/5 mL
2
149
4
20 mEq/10 mL
2
149
4
30 mEq/15 mL
2
149
4
40 mEq/20 mL
2
149
4
The solutions contain no bacteriostat, antimicrobial agent or added
buffer (except for pH
adjustment) and each is intended only for single-dose injection (after
dilution). When
smaller doses are required, discard the unused portion. The pH is 4.6
(4.0 to 8.0).
Potassium Chloride for Injection Concentrate, USP (appropriately
diluted) is a parenteral
fluid and electrolyte replenisher.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely
soluble in water.
The semi-rigid material used for the plastic vials 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_
May contain hydrochloric acid for pH adjustment.
*
+
Potassium is the chief cation of body cells (160 mEq/liter of
intracellular water) and is
concerned with the maintenance of body fluid composition and
electroly