POTASSIUM ACETATE injection, solution, concentrate

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Hospira, Inc.

ИНН (Международная Имя):

POTASSIUM ACETATE

состав:

POTASSIUM ACETATE 3.93 g in 20 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Potassium Acetate Injection, USP, 40 mEq 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.

Обзор продуктов:

Potassium Acetate Injection, USP is supplied as follows: Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-0902-4.0 Revised: 11/2020

Статус Авторизация:

New Drug Application

Характеристики продукта

POTASSIUM ACETATE- POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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POTASSIUM ACETATE INJECTION USP
POTASSIUM ACETATE
INJECTION, USP
40 MEQ/20 ML (2 MEQ/ML)
_FOR ADDITIVE USE ONLY AFTER_
_DILUTION IN INTRAVENOUS FLUIDS_
PLASTIC VIAL
RX ONLY
DESCRIPTION
Potassium Acetate Injection, USP, 40 mEq (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 20 mL vial contains 3.93 g of potassium acetate which provides 40
mEq each of
potassium (K ) and acetate (CH COO ). It contains no bacteriostat,
antimicrobial agent
or added buffer. May contain acetic acid for pH adjustment. pH 6.2
(5.5 to 8.0). The
osmolar concentration is 4 mOsmol/mL (calc.).
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, colorless
crystals or white
crystalline powder very soluble in water.
The semi-rigid vial 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
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 to 5.0
mEq/liter. The kidney normally regulates potassium balance but does
not conserve
potassium as well or as promptly as it conserves sodium. The daily
turnover of
potassium in the normal adult averages 50 to 150 mEq
(milliequivalents) and represents
1.5 to 5% of the total p