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)

Available from:

Physicians Total Care, 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: Store at controlled room temperature 15° to 30°C (59° to 86°F) [See USP.] ©Hospira 2004 EN-0069 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE - POTASSIUM CHLORIDE INJECTION, SOLUTION,
CONCENTRATE
PHYSICIANS TOTAL CARE, INC.
----------
R only
CONCENTRATE
_MUST BE DILUTED BEFORE USE._
FOR INTRAVENOUS INFUSION ONLY;
MUST BE DILUTED PRIOR TO INJECTION.
AMPULS
FLIPTOP VIALS
PINTOP VIALS
PRESSURIZED PINTOP 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. &
S IZE)
K
mEq/mL
KCl
mg/mL
mOsmol/mL
(calc.)
30 mEq/20
mL
1.5
112
3
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
* May contain hydrochloric acid for pH adjustment.
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
x
+
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
Potassium is the chief cation of body cells (160 mEq/liter of
intracellular water) and is concerned with
the maintenance of body fluid