POTASSIUM ACETATE injection, solution, concentrate

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152)

Disponible depuis:

Hospira, Inc.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

Descriptif du produit:

Potassium Acetate Injection, USP is a Pharmacy Bulk Package which provides multiple single doses for continuous admixture compounding procedures is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-0930-4.0 Revised: 11/2020

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

POTASSIUM ACETATE- POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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POTASSIUM ACETATE INJECTION, USP
POTASSIUM ACETATE
INJECTION, USP
100 MEQ/50 ML
(2 MEQ/ML)
(2 MEQ K /ML AND 2 MEQ CH COO /ML)
PHARMACY BULK PACKAGE - NOT FOR
DIRECT INFUSION.
CONCENTRATED SOLUTION –
FOR INTRAVENOUS USE ONLY AFTER DILUTION AND THOROUGH MIXING.
GLASS FLIPTOP
VIAL
RX ONLY
DESCRIPTION
Potassium Acetate Injection, USP (2 mEq/mL) is a sterile,
nonpyrogenic, _concentrated_
_solution_ of potassium acetate in water for injection. The solution
is administered after
dilution by the intravenous route as an electrolyte replenisher. _It
must not be_
_administered undiluted._
Each mL contains 196 mg of potassium acetate which provides 2 mEq each
of
potassium (K ) and acetate (CH COO¯). The solution may contain acetic
acid for pH
adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar
concentration is 4
mOsmol/mL (calc.); specific gravity is 1.089.
The Pharmacy Bulk Package is a sterile dosage which contains multiple
single doses for
use only in a pharmacy bulk admixture program.
The solution is intended as an alternative to potassium chloride to
provide potassium ion
(K ) for addition to large volume infusion fluids for intravenous use.
Potassium Acetate, USP is chemically designated CH COOK, and is
comprised of
colorless crystals or a white crystalline powder that is very soluble
in water.
The Pharmacy Bulk Package is designed for use with manual, gravity
flow operations
and automated compounding devices for preparing sterile parenteral
nutrient
admixtures. The Pharmacy Bulk Package contains no bacteriostat,
antimicrobial agent,
or added buffer. Multiple single doses may be dispensed during
continual aliquoting
operations.
+
3
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+
3
+
3
CLINICAL PHARMACOLOGY
As the principal cation of the intracellular fluid, potassium plays an
important role in fluid
and electrolyte balance. The normal potassium concentration in the
intracellular fluid
compartment is about 160 mEq/liter. The normal serum potassium range
is 3.5