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:

B. Braun Medical Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 14.9 g in 100 mL

Administration route:

PARENTERAL

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. This is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion. Potassium Chloride for Injection Concentrate USP is contraindicated in diseases where high potassium levels may be encountered, in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present, or where additives of potassium and chloride could be clinically detrimental.

Product summary:

Potassium Chloride for Injection Concentrate USP (2 mEq K+ /mL) is supplied sterile and nonpyrogenic in 250 mL glass containers with solid stoppers, Pharmacy Bulk Packages, packaged 12 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat (40°C/104°F). Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE INJECTION, SOLUTION,
CONCENTRATE
B. BRAUN MEDICAL INC.
----------
POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE USP
(2 MEQ K /ML)
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
FOR INTRAVENOUS INFUSION ONLY
MUST BE DILUTED PRIOR TO INJECTION
DESCRIPTION
A pharmacy bulk package is a container of a sterile preparation for
parenteral use that
contains many single doses. The contents are intended for use in a
pharmacy admixture
service and are restricted to the preparation of admixtures for
intravenous infusion.
Potassium Chloride for Injection Concentrate USP is a sterile,
nonpyrogenic,
concentrated solution of Potassium Chloride USP in Water for Injection
USP to be
administered by intravenous infusion only after dilution in a larger
volume of fluid. No
bacteriostatic or antimicrobial agent has been added.
Each 100 mL of Potassium Chloride contains:
Potassium Chloride USP 14.9 g; Water for Injection USP qs
pH: 5.4 (4.0–8.0); Calculated Osmolarity: 4000 mOsmol/liter
Concentration of Electrolytes (mEq/mL): Potassium 2; Chloride 2
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULAMOLECULAR WEIGHT
Potassium Chloride USP
KCl
74.55
Potassium chloride injection (approximately diluted) is a parenteral
fluid and electrolyte
replenisher.
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 composition and
electrolyte balance.
Potassium participates in carbohydrate utilization and protein
synthesis, and is critical in
the regulation of nerve conduction and muscle contraction,
particularly in the heart.
Chloride, the major extracellular anion, closely follows the
metabolism of sodium and
changes in the acid-base balance of the body are reflected by changes
in the chloride
concentration.
Normally about 80 to 90% of the potassium intake is excreted in the
urine, the
+
remainder in the stools and to a small extent, in the perspiration.
The kidney does not
conserve potassi