Tpn Electrolytes
Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, And Sodium Acetate Anhydrous
Hospira, Inc.
Human Prescription Drug
NDC 0409-5779Tpn Electrolytes also known as Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, And Sodium Acetate Anhydrous is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Tpn Electrolytes is 0409-5779. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Tpn Electrolytes drug includes Calcium Chloride - 331 mg/20mL Magnesium Chloride - 508 mg/20mL Potassium Chloride - 1491 mg/20mL Sodium Acetate Anhydrous - 2420 mg/20mL Sodium Chloride - 321 mg/20mL . The currest status of Tpn Electrolytes drug is Active.
Drug Information:
| Drug NDC: | 0409-5779 |
| 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: | Tpn Electrolytes |
| 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 Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, And Sodium Acetate Anhydrous |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hospira, Inc. |
| 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: | CALCIUM CHLORIDE - 331 mg/20mL
MAGNESIUM CHLORIDE - 508 mg/20mL
POTASSIUM CHLORIDE - 1491 mg/20mL
SODIUM ACETATE ANHYDROUS - 2420 mg/20mL
SODIUM CHLORIDE - 321 mg/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: | NDA |
| 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: | 28 Feb, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 2026 |
| 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: | NDA018895 |
| 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: | Hospira, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 801451
|
| 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: | M4I0D6VV5M
02F3473H9O
660YQ98I10
NVG71ZZ7P0
451W47IQ8X
|
| 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: | Blood Coagulation Factor [EPC]
Calcium [CS]
Calculi Dissolution Agent [EPC]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
|
| 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 |
|---|
| 0409-5779-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-5779-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-5779-11) | 28 Feb, 2005 | 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:
Tpn electrolytes sodium chloride, calcium chloride, potassium chloride, magnesium chloride, and sodium acetate anhydrous sodium chloride sodium cation chloride ion calcium chloride calcium cation chloride ion potassium chloride potassium cation chloride ion magnesium chloride magnesium cation chloride ion sodium acetate anhydrous sodium cation acetate ion water hydrochloric acid
Indications and Usage:
Indications and usage tpn electrolytes (multiple electrolyte additive) is indicated for use as a supplement to nutritional solutions containing concentrated dextrose and amino acids delivered by central venous infusion, to help maintain electrolyte homeostasis in adult patients.
Warnings:
Warnings concentrated, hypertonic, additive solution. must be diluted in tpn solution prior to administration. contains no phosphate. patients receiving tpn solutions containing concentrated dextrose require additive phosphate, in addition to tpn electrolytes. between 10 and 15 mm (310 to 465 mg) phosphorus are physically compatible with as much as 10 to 12 meq calcium in the same admixture. the phosphate supplement should first be added to the amino acid or dextrose bottle and diluted well to avoid precipitation with calcium. contains 20 meq of potassium. the potassium content of other additives, such as potassium phosphate or potassium-containing antibiotics, must be considered in the context of total potassium delivered. tpn patients usually require 30 to 50 meq of potassium per liter of tpn solution containing concentrated (20â25%) dextrose. not intended for pediatric use. solutions containing sodium ions should be used with great care, if at all, in patients with congestive h
Read more...eart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. 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 sodium or potassium ions may result in sodium or 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 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 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 one 20 ml volume of tpn electrolytes (multiple electrolyte additive) is added to each liter of amino acid/dextrose solution. alternatively, the tpn electrolytes can be added to the bottle of amino acids or concentrated dextrose, to permit addition of the necessary phosphate additive to the remaining bottle. this latter technique helps avoid physical incompatibilities between calcium and phosphorus. a potassium phosphate additive is recommended for addition to nutritional solutions containing tpn electrolytes. between 10 and 30 meq of potassium (as phosphate) should be added per liter of tpn solution, to augment the 20 meq of potassium provided by tpn electrolytes. between two and three liters of tpn solution with added tpn electrolytes are usually administered daily to adults. solutions are given continuously over the entire 24-hour period at a constant rate, ranging from 83 to 125 ml/hour. tpn solutions containing tpn electrolytes and concentrated dextrose ar
Read more...e administered intravenously, through a central venous catheter. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions.
Contraindications:
Contraindications tpn electrolytes (multiple electrolyte additive) is contraindicated in pathological conditions where additives of potassium, sodium, calcium, magnesium or chloride could be clinically deleterious, e.g., anuria, hyperkalemia, heart block or myocardial damage and severe edema due to cardiovascular, renal or hepatic failure.
Adverse Reactions:
Adverse reactions symptoms may result from an excess or deficit of one or more of the ions present in tpn electrolytes. therefore, frequent monitoring of electrolyte blood levels is recommended. sodium excess can cause edema and exacerbation of congestive heart failure. excess potassium can cause deviations from the normal ecg (electrocardiogram). potassium deficits can impair neuromuscular function, causing muscle weakness or frank paralysis, intestinal dilatation and ileus. calcium deficits can produce neuromuscular hyperexcitability, ranging from paresthesias, cramps and laryngospasm to tetany and grand mal seizures. depressed calcium levels can accompany administration of parenteral phosphorous or large amounts of albumin. magnesium deficiency can precipitate neuromuscular dysfunction, hyperirritability, psychotic behavior, tachycardia and hypertension. magnesium excess can cause muscle weakness, ecg changes, sedation and mental confusion.
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with tpn electrolytes. it is also not known whether tpn electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. tpn electrolytes should be given to a pregnant woman only if clearly needed.
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 and phosphorus are known to be substantially secreted 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 overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. see warnings and precautions .
Description:
Description tpn electrolytes (multiple electrolyte additive) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular ions for intravenous infusion after dilution as a maintenance electrolyte replenisher only. it contains no phosphate and no bacteriostat, antimicrobial agent or added buffer. the ph is 6.6 (6.0 to 7.5). may contain hydrochloric acid for ph adjustment. the osmolar concentration is 6.2 mosmol/ml (calc.). __________________________ *total parenteral nutrition ingredients and ion constituents of the solution are as follows: ingredient or ion mg/20 ml meq/20 ml sodium chloride 321 calcium chloride (dihydrate) 331 potassium chloride 1491 magnesium chloride (hexahydrate) 508 sodium acetate (anhydrous) 2420 sodium (na + ) 35 potassium (k + ) 20 calcium (ca ++ ) 4.5 magnesium (mg ++ ) 5 chloride (cl â ) 35 acetate (ch 3 coo â ) 29.5 sodium chloride, usp is chemically designated nacl, a white crystalline compound freely soluble in water. calcium chloride, usp dihydrate is chemically designated cacl 2 ⢠2h 2 o, white, odorless fragments or granules, freely soluble in water. potassium chloride, usp is chemically designated kcl, a white granular powder freely soluble in water. magnesium chloride, usp hexahydrate is chemically designated mgcl 2 ⢠6h 2 o, deliquescent crystals very soluble in water. sodium acetate, usp anhydrous is chemically designated c 2 h 3 nao 2 , a hygroscopic powder very soluble in water. water for injection, usp is chemically designated h 2 o. the semi-rigid container 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.
Clinical Pharmacology:
Clinical pharmacology tpn electrolytes (multiple electrolyte additive) helps to maintain normal cellular metabolism during tpn (total parenteral nutrition). providing electrolytes in appropriate amounts prevents deficiency symptoms which otherwise would occur in their absence. cations: sodium is the principal extracellular cation; it helps maintain motor nerve depolarization, proper fluid balance and normal renal metabolism. potassium is the principal intracellular cation; it helps transport dextrose across the cell membrane and contributes to normal renal function. magnesium is an important cofactor for enzymatic reactions and helps to maintain normal cns (central nervous system) activity and amino acid utilization. calcium participates in muscle contraction, blood coagulation and helps maintain normal neuromuscular function. anions: chloride is the principal extracellular anion which, along with bicarbonate, is involved in maintaining proper anion balance. acetate is an important met
Read more...abolic intermediate in the tricarboxylic acid cycle and is a bicarbonate alternate. the distribution and excretion of sodium (na + ) and chloride (cl â ) are largely under the control of the kidney which maintains a balance between intake and output. approximately 80% of body calcium (ca ++ ) is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. potassium (k + ) is found in low concentration in the plasma and extracellular fluids (3.5 to 5.0 meq/liter in a healthy adult). normally about 80% to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. the kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. magnesium (mg ++ ) is the second most plentiful intracellular cation. normal plasma concentration ranges from 1.5 to 2.5 or 3.0 meq per liter. magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration. acetate (ch 3 coo â ) provides bicarbonate (hco 3 â ) 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 tpn electrolytes (multiple electrolyte additive) is supplied in the following single-dose delivery system: unit of sale concentration each ndc 0409-5779-01 25 in a carton 20 ml ndc 0409-5779-11 20 ml vial exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. 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-1091-1.0 revised: 9/2017 logo
Package Label Principal Display Panel:
Principal display panel - 20 ml vial label 20 ml single-dose tpn* electrolytes multiple electrolyte additive rx only *total parenteral nutrition caution: must be diluted. for intravenous use. distributed by hospira, inc., lake forest, il 60045 usa principal display panel - 20 ml vial label
Principal display panel - 20 ml vial carton 20 ml single-dose ndc 0409-5779-01 contains 25 of ndc 0409-5779-11 tpn* electrolytes multiple electrolyte additive *total parenteral nutrition rx only caution: must be diluted. for intravenous use. hospira principal display panel - 20 ml vial carton