POTASSIUM CHLORIDE injection, solution, concentrate

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Fresenius Kabi USA, LLC

INN (Mezinárodní Name):

POTASSIUM CHLORIDE

Složení:

POTASSIUM CATION 2 meq in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 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.

Přehled produktů:

The following are packaged in plastic vials. These are Single Dose Vials, no preservative added, packaged 25 vials per tray.  Unused portion of vial should be discarded. This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear, seal intact and undamaged. Vial stoppers do not contain natural rubber latex.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

POTASSIUM CHLORIDE - POTASSIUM CHLORIDE INJECTION, SOLUTION,
CONCENTRATE
FRESENIUS KABI USA, LLC
----------
POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE USP
Rx only
CONCENTRATE MUST BE
DILUTED BEFORE USE
_FOR INTRAVENOUS INFUSION ONLY_
_MUST BE DILUTED PRIOR TO INJECTION_
DESCRIPTION:
Potassium Chloride for Injection Concentrate, USP is a sterile,
nonpyrogenic
concentrated solution of Potassium Chloride, USP in Water for
Injection to be
administered by intravenous infusion only after dilution in a larger
volume of fluid.
Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq
of K and
Cl_ _equivalent to 149 mg of potassium chloride and has an osmolarity
of 4000 mOsmol/L
(calc). A more concentrated Potassium Chloride for Injection
Concentrate is also
available. Each mL of this injection contains 3 mEq of K and Cl
equivalent to 224 mg of
potassium chloride and has an osmolarity of 6000 mOsmol/L(calc).
pH (4.0-8.0) may have been adjusted with hydrochloric acid and if
necessary, potassium
hydroxide.
Some packages are intended for multiple dose use and contain
preservatives (0.05%
methylparaben and 0.005% propylparaben). A summary of the available
products is
presented in the HOW SUPPLIED section.
Potassium Chloride for Injection Concentrate (appropriately diluted)
is a parenteral fluid
and electrolyte replenisher.
CLINICAL PHARMACOLOGY:
Potassium is the chief cation of body cells (160 mEq/L 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 perspirati