País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152)
Exela Pharma Sciences, LLC
POTASSIUM ACETATE
POTASSIUM ACETATE 3.93 g in 20 mL
INTRAVENOUS
PRESCRIPTION DRUG
Potassium Acetate Injection, USP 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, 40 mEq (2 mEq/mL) of K+ is supplied in a carton of 25, 20 mL partial-fill single-dose fliptop glass vials. Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the I.V. container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October 2015 Exela Pharma Sciences, LLC. Lenoir, NC 28645 USA
Abbreviated New Drug Application
POTASSIUM ACETATE- POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE EXELA PHARMA SCIENCES, LLC ---------- POTASSIUM ACETATE INJECTION USP POTASSIUM ACETATE INJECTION, USP 40 MEQ IN 20 ML (2 MEQ K+ AND 2 MEQ CH COO /ML) FOR ADDITIVE USE ONLY AFTER DILUTION IN INTRAVENOUS FLUIDS USP TYPE I GLASS 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 (CH3COO ). 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 vial is fabricated from USP Type I glass. 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 potassium content of the body. Acetate (CH COO ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO ) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver Leer el documento completo