Potassium Acetate
Exela Pharma Sciences, Llc
Human Prescription Drug
NDC 51754-2001Potassium Acetate is a human prescription drug labeled by 'Exela Pharma Sciences, Llc'. National Drug Code (NDC) number for Potassium Acetate is 51754-2001. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Potassium Acetate drug includes Potassium Acetate - 3.93 g/20mL . The currest status of Potassium Acetate drug is Active.
Drug Information:
| Drug NDC: | 51754-2001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Potassium Acetate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Exela Pharma Sciences, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution, Concentrate |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM ACETATE - 3.93 g/20mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 07 Jan, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA206203 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Exela Pharma Sciences, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1871155
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0351754200148
|
| UPC stands for Universal Product Code. |
| UNII: | M911911U02
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51754-2001-4 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-2001-4) / 20 mL in 1 VIAL, SINGLE-DOSE | 07 Jan, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Potassium acetate potassium acetate potassium acetate potassium cation water acetic acid
Indications and Usage:
Indications and usage 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.
Warnings:
Warnings potassium acetate injection, usp must be diluted before use. to avoid potassium intoxication, infuse potassium-containing solutions slowly. potassium replacement therapy should be monitored whenever possible by continuous or serial electrocardiography (ecg). serum potassium levels are not necessarily dependable indicators of tissue potassium levels. solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. in patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. warning: this
Read more... product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration.
Dosage and Administration:
Dosage and administration potassium acetate injection, usp 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 con
Read more...tainer permit. see precautions .
Contraindications:
Contraindications potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.
Adverse Reactions:
Adverse reactions adverse reactions involve the possibility of potassium intoxication. the signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of p waves, spreading and slurring of the qrs complex with development of a biphasic curve and cardiac arrest. see warnings and precautions .
Overdosage:
Overdosage in the event of overdosage, discontinue infusion containing potassium acetate immediately and institute corrective therapy as indicated to reduce elevated serum potassium levels and restore acid-base balance if necessary. see warnings , precautions , and adverse reactions .
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 (ch3coo â ). 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 vial is fabricated from usp type i glass.
Clinical Pharmacology:
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 3 coo - ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (hco 3 - ) by metabolic conversion in the liver. this has been shown to proceed readily, even in the presence of severe liver disease.
How Supplied:
How supplied 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
Package Label Principal Display Panel:
Package/label principal display panel-vial label ndc 51754-2001-4 rx only potassium k + acetate injection, usp 40 meq/20 ml (2meq/ml) caution: must be diluted. for intravenous use. 20 ml single dose vial vial label
Package/label principal display panel-carton label ndc 51754-2001-4 rx only potassium k + acetate injection, usp 40 meq/20 ml (2meq/ml) caution: must be diluted. for intravenous use. 25 x 20 ml single dose vials carton