Sodium Acetate
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-032Sodium Acetate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sodium Acetate is 63323-032. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Sodium Acetate drug includes Sodium Acetate - 4 meq/100mL . The currest status of Sodium Acetate drug is Active.
Drug Information:
| Drug NDC: | 63323-032 |
| 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: | Sodium 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: | Sodium Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, 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: | SODIUM ACETATE - 4 meq/100mL
|
| 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: | 30 Oct, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA206687 |
| 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: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312965
|
| 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. |
| UNII: | 4550K0SC9B
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-032-00 | 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04) | 30 Oct, 2017 | 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:
Sodium acetate sodium acetate water acetic acid sodium acetate acetate ion sodium cation sodium acetate anhydrous
Indications and Usage:
Indications and usage: sodium acetate injection, usp (4 meq per ml) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia 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: sodium acetate injection, usp (4 meq per ml) must be diluted before use. to avoid sodium overload and water retention, infuse sodium-containing solutions slowly. solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. in patients with diminished renal function, administration of solutions containing sodium ions may result in sodium 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. the intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentration
Read more...s, overhydration, congested states or pulmonary edema. excessive administration of potassium free solutions may result in significant hypokalemia. warning: this 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: sodium acetate injection, usp (4 meq per ml) 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. serum sodium should be monitored as a guide to dosage. using aseptic technique, transfer the desired amount to other intravenous fluids to provide the appropriate number of milliequivalents (meq) of sodium acetate. sodium acetate injection, usp (4 meq per ml) in the pharmacy bulk package is designed for use with manual, gravity flow operations and automated compounding devices for preparing intravenous nutritional admixtures. admixtures must be stored under refrigeration and used within 24 hours after compounding. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see precautions ). directions for dispensing from pharmacy bulk package the pharmacy bulk package is for use in the p
Read more...harmacy admixture service only in a laminar flow hood. it should be inserted into the ring sling (plastic hanging device) provided and suspended as a unit in the laminar flow hood. the container closure should be penetrated only one time utilizing a suitable sterile dispensing set which allows measured distribution of the contents. swab vial stopper with an antiseptic solution. insert the dispensing set into the vial using aseptic technique (see graphic illustration below ). once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. however, if this is not possible, a maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. discard the container no later than 4 hours after initial closure puncture. do not administer unless solution is clear and seal is intact. figure
Contraindications:
Contraindications: sodium acetate injection, usp (4 meq per ml) is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions:
Adverse reactions: sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (see warnings and precautions ).
Use in Pregnancy:
Pregnancy pregnancy category c animal reproduction studies have not been conducted with sodium acetate injection, usp. it is also not known whether sodium acetate injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium acetate injection, usp should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness have been established in the age groups infant to adolescent.
Geriatric Use:
Geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage:
Overdosage: in the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary (see warnings , precautions and adverse reactions ).
Description:
Description: sodium acetate injection, usp (4 meq per ml) is a sterile, nonpyrogenic, concentrated solution of sodium 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: 328 mg sodium acetate (anhydrous) which provides 4 meq each of sodium (na + ) and acetate (ch 3 coo - ). the solution contains no bacteriostat, antimicrobial agent or added buffer. the ph may have been adjusted with glacial acetic acid to 6.5 (6.0 to 7.0). the osmolar concentration is 8 mosmol/ml (calc); specific gravity 1.1511. the solution is intended as an alternative to sodium chloride to provide sodium ion (na + ) for addition to large volume infusion fluids for intravenous use. sodium acetate, usp anhydrous is chemically designated as ch 3 coona, a hygroscopic powder very soluble in water. a pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. the contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
Clinical Pharmacology:
Clinical pharmacology: sodium is the principal cation of extracellular fluid. it comprises more than 90% of total cations at its normal plasma concentration of approximately 140 meq/l. the sodium ion exerts a primary role in controlling total body water and its distribution. acetate (ch 3 coo - ) is a hydrogen ion acceptor. it also serves as an alternate source of bicarbonate (hco 3 - ) by metabolic conversion in the liver. this conversion has been shown to proceed readily, even in the presence of severe liver disease.
How Supplied:
How supplied: sodium acetate injection, usp is packaged in a pharmacy bulk package vial, 20 vials per tray, and is available as follows: product no. ndc no. sodium acetate content (%) na + (sodium) meq/ml ch 3 coo - (acetate) meq/ml mosmol/ml fill vol. (ml) 322100 63323-032-00 32.8 4 4 8 100 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. lake zurich, il 60047 www.fresenius-kabi.com/us 451406 issued: december 2017 figure
Package Label Principal Display Panel:
Package label - principal display â sodium acetate 400 meq per 100 ml vial label ndc 63323-032-04 sodium acetate injection, usp 400 meq per 100 ml (4 meq per ml) pharmacy bulk packageâ not for direct infusion caution: must be diluted for intravenous use only 100 ml rx only package label - principal display â sodium acetate 400 meq per 100 ml vial label
Package label - principal display â sodium acetate 400 meq per 100 ml tray label ndc 63323-032-00 sodium acetate injection, usp 400 meq per 100 ml (4 meq per ml) pharmacy bulk packageâ not for direct infusion for intravenous use only 20 (1 x 20) 100 ml vials rx only package label - principal display â sodium acetate 400 meq per 100 ml tray label