Copper

Cupric Chloride


Hospira, Inc.
Human Prescription Drug
NDC 0409-4092
Copper also known as Cupric Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Copper is 0409-4092. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Copper drug includes Cupric Chloride - .4 mg/mL . The currest status of Copper drug is Active.

Drug Information:

Drug NDC: 0409-4092
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: Copper
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: Cupric Chloride
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
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:CUPRIC CHLORIDE - .4 mg/mL
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: 30 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: NDA018960
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:204536
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:S2QG84156O
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0409-4092-0125 VIAL, SINGLE-DOSE in 1 TRAY (0409-4092-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-4092-11)28 Feb, 2005N/ANo
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:

Copper cupric chloride cupric chloride cupric cation sodium chloride hydrochloric acid sodium hydroxide water

Drug Interactions:

Drug interactions cupric ion may degrade ascorbic acid in total parenteral nutrition (tpn) solutions. in order to avoid this loss of ascorbate, multivitamin additives should be added to tpn solutions immediately prior to infusion. alternatively, the multivitamin additive may be added to one container of tpn solution, followed by copper in a subsequent container.

Indications and Usage:

Indications and usage copper 0.4 mg/ml (cupric chloride injection, usp) is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Warnings:

Warnings direct intramuscular or intravenous injection of copper 0.4 mg/ml (cupric chloride injection, usp) is contraindicated, as the acidic ph of the solution (2) may cause considerable tissue irritation. liver and/or biliary tract dysfunction may require omission or reduction of copper and manganese doses because these elements are primarily eliminated in the bile. 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 low
er rates of administration.

General Precautions:

General do not use unless the solution is clear and the seal is intact. administration of zinc in the absence of copper may cause a decrease in serum copper levels. copper 0.4 mg/ml (cupric chloride injection, usp) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. solution contains no preservatives; discard unused portion immediately after admixture procedure is completed. it is not recommended to administer copper to a patient with wilson’s disease, a genetic disease of copper metabolism.

Dosage and Administration:

Dosage and administration copper 0.4 mg/ml (cupric chloride injection, usp) contains 0.4 mg copper/ml and is administered intravenously only after dilution. the additive should be diluted in a volume of fluid not less than 100 ml. for the adult receiving tpn, the suggested additive dosage is 0.5 to 1.5 mg copper/day (1.25 to 3.75 ml/day). for pediatric patients, the suggested additive dosage is 20 mcg copper/kg/day (0.05 ml/kg/day). infants weighing less than 1500 gm may have increased requirements because of their low body reserves and increased requirements for growth. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (see precautions .)

Contraindications:

Contraindications none known.

Adverse Reactions:

Adverse reactions none known.

Drug Interactions:

Drug interactions cupric ion may degrade ascorbic acid in total parenteral nutrition (tpn) solutions. in order to avoid this loss of ascorbate, multivitamin additives should be added to tpn solutions immediately prior to infusion. alternatively, the multivitamin additive may be added to one container of tpn solution, followed by copper in a subsequent container.

Use in Pregnancy:

Pregnancy animal reproduction studies have not been conducted with cupric chloride. it is also not known whether cupric chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. cupric chloride should be given to a pregnant woman only if clearly indicated.

Pediatric Use:

Pediatric use (see dosage and administration section.) there are limited data in infants weighing less than 1500 grams.

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.

Overdosage:

Overdosage copper toxicity can produce prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. such symptoms have been reported with a serum copper level of 286 mcg/dl. copper toxicity can also result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. d-penicillamine has been reported effective as an antidote.

Description:

Description copper 0.4 mg/ml (cupric chloride injection, usp) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (tpn). each ml of solution contains 1.07 mg cupric chloride, dihydrate and 9 mg sodium chloride. the solution contains no bacteriostat, antimicrobial agent or added buffer. the ph is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for ph adjustment. the osmolarity is 0.327 mosmol/ml (calc.). cupric chloride, usp is chemically designated cupric chloride, dihydrate (cucl 2 • 2h 2 o), a crystalline compound freely soluble in water. sodium chloride, usp is chemically designated nacl, a white crystalline compound freely 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 small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.

Clinical Pharmacology:

Clinical pharmacology copper is an essential nutrient which serves as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. copper also helps maintain normal rates of red and white blood cell formation. providing copper during tpn helps prevent development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation, secondary iron deficiency and osteoporosis. normal serum copper values range from 80 to 163 mcg/dl (mean, approximately 110 mcg/dl). the serum copper level at which deficiency symptoms appear is not precisely defined. a serum value of 9 mcg copper/dl was reported for one tpn patient who received no copper. the daily turnover of copper through ceruloplasmin is approximately 0.5 mg. excretion of copper is through the bile (80%), directly through the intestinal wall (16%) and in urine (4%).

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility long-term animal studies to evaluate the carcinogenic potential of copper 0.4 mg/ml (cupric chloride injection, usp) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

How Supplied:

How supplied copper 0.4 mg/ml (cupric chloride injection, usp) is supplied as follows: unit of sale concentration ndc 0409-4092-01 tray containing 25 - 10 ml single-dose plastic vials 4 mg/10 ml (0.4 mg/ml) 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-1067-2.0 revised: 04/2021 hospira logo

Package Label Principal Display Panel:

Principal display panel - 10 ml vial label 10 ml single-dose vial ndc 0409-4092-11 copper rx only 4 mg/10 ml (0.4 mg/ml) cupric chloride inj., usp for intravenous use only after dilution. distributed by hospira, inc., lake forest, il 60045 usa hospira principal display panel - 10 ml vial label

Principal display panel - 10 ml vial tray 10 ml single-dose vial ndc 0409-4092-01 contains 25 of ndc 0409-4092-11 copper rx only 4 mg/10 ml (0.4 mg/ml) caution: for intravenous use only after dilution. cupric chloride injection, usp hospira principal display panel - 10 ml vial tray


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