מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152)
Hospira, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
New Drug Application
POTASSIUM ACETATE- POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE HOSPIRA, INC. ---------- 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 - + 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 קרא את המסמך השלם