Drug Catalog - Product Detail
POTASSIUM ACET 2MEQ/ML IV SOL 20ML X 25
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00409-8183-01 | HOSPIRA | 20 | 2MEQ/ML | NA |
PACKAGE FILES
Generic Name
POTASSIUM ACETATE
Substance Name
POTASSIUM ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
NDA018896
Description
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 3 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 3 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.
How Supplied
HOW SUPPLIED Potassium Acetate Injection, USP is supplied as follows: Unit of Sale Concentration Each NDC 0409-8183-01 Carton of 25 40 mEq/20 mL (2 mEq/mL) NDC 0409-8183-11 Single-Dose Fliptop Vial Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0901-2.0 9/2017 Logo
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Potassium Acetate Injection, USP, 40 mEq is administered intravenously only after dilution in a larger volume of fluid . The dose and rate of administration are dependent upon the individual needs of the patient. ECG and serum potassium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of potassium (K + ) with an equal number of milliequivalents of acetate (CH 3 COO − ). Maximum infusion rate: The infusion rate should not exceed 1 mEq/kg/hr. Normal daily requirements: Newborn: 2-6 mEq/kg/24 hr. Children: 2-3 mEq/kg/24 hr. Adult: 40-80 mEq/24 hr. Intraosseous infusion can be an alternate route for drug administration when intravenous access is not readily available. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)