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:

Baxter Healthcare Corporation

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 29.8 g in 1000 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 patients with:

Product summary:

Potassium Chloride Injection in VIAFLEX Plus plastic containers is available as follows: 2B0826 10 mEq/100 mL NDC 0338-0709-48 2B0821 10 mEq/50 mL NDC 0338-0705-41 2B0827 20 mEq/100 mL NDC 0338-0705-48 2B0822 20 mEq/50 mL NDC 0338-0703-41 2B0824 40 mEq/100 mL NDC 0338-0703-48 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that this product be stored at room temperature (25°C).

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
FOR USE ONLY WITH A CALIBRATED INFUSION DEVICE
HIGHLY CONCENTRATED
POTASSIUM CHLORIDE INJECTION
IN PLASTIC CONTAINER
READY TO USE
VIAFLEX PLUS CONTAINER
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
COMPOSITION
(G/L)
POTASSIUM
CHLORIDE, USP
(KCL)
OSMOLARITY
(MOSMOL/L)
(CALC)
PH
IONIC CONCENTRATION
(MEQ/L)
POTASSIUM CHLORIDE
*
10 mEq/100 mL
7.46
200
5.0
(4.0 to
8.0)
100
100
10 mEq/50 mL
20 mEq/100 mL
14.9
400
5.0
(4.0 to
8.0)
200
200
20 mEq/50 mL
40 mEq/100 mL
29.8
799
5.0
(4.0 to
8.0)
400
400
This VIAFLEX Plus plastic container is fabricated from a specially
formulated polyvinyl
chloride (PL 146 Plastic). 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.
*
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L. Administration of
substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein
damage.
CLINICAL PHARMACOLOGY
Potassium is the major cation of body cells (160 mEq/liter of
intracellular water) and is
concerned with the maintenance of body fluid composition and
electrolyte balance.
Potassium participat