COPPER

COPPER is an FDA-registered drug product whose active ingredient is CUPRIC CHLORIDE. It is labelled by Hospira, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0409-4092, application NDA018960, label effective 20260518. It is one of 4 FDA drug label records sharing the active ingredient CUPRIC CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CUPRIC CHLORIDE are most often described in connection with: usage copper, cupric chloride, injection indicated, supplement intravenous, solutions given, tpn administration, helps maintain, serum levels. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Copper (Cupric Chloride Injection) 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.

DOSAGE AND ADMINISTRATION • Copper (Cupric Chloride Injection) contains 0.4 mg of copper per 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 of copper is 0.3 to 0.5 mg/day. • For pediatric patients, the suggested additive dosage of copper is 20 mcg/kg/day (0.05 mL/kg/day) up to a maximum of 500 mcg/day. • This product is not appropriate for patients weighing less than 4 kg due to the inability to measure the appropriate amount of the product. • Do not administer Copper (Cupric Chloride Injection) intramuscularly because the acidic pH of the solution may cause considerable tissue irritation. Copper (Cupric Chloride Injection) 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. The solution contains no preservatives; discard the unused portion immediately after the admixture procedure is completed. Copper (Cupric Chloride Injection) should be inspected visually for particulate matter and discoloration prior to administration. Do not use unless the solution is clear, and the seal is intact. Cupric ion may degrade ascorbic acid in 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.

CONTRAINDICATIONS Copper (Cupric Chloride Injection) is contraindicated in patients with hypersensitivity to copper (see WARNINGS: Hypersensitivity Reactions ).

WARNINGS Hepatic Accumulation Copper is primarily eliminated in the bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of copper has been reported in autopsies of patients receiving long-term parenteral nutrition containing copper at dosages higher than recommended. Administration of copper to patients with cholestasis and/or cirrhosis may cause hepatic accumulation of copper. Administration of copper to patients with Wilson disease, an inborn error of copper metabolism with a defect in hepatocellular copper transport, may cause both increased hepatic accumulation of copper and aggravation of the underlying hepatocellular degeneration. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of Cupric Chloride Injection. If a patient develops signs or symptoms of hepatobiliary disease during the use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin, and adjust the dose as indicated (see PRECAUTIONS: Hepatic Impairment ). Hypersensitivity Reactions Postmarket safety reporting has identified copper hypersensitivity in women receiving copper-containing intrauterine devices, providing evidence that patients may experience hypersensitivity reactions when exposed to this metal. If hypersensitivity reactions (e.g., pruritis, angioedema, dyspnea, rash, urticaria) occur in patients receiving Cupric Chloride Injection in parenteral nutrition, discontinue the product, and initiate appropriate medical treatment (see CONTRAINDICATIONS ). Aluminum Toxicity 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.

ADVERSE REACTIONS None known.

FDA lists 4 drug label records with CUPRIC CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is COPPER used for?
INDICATIONS AND USAGE Copper (Cupric Chloride Injection) 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.

Who makes COPPER?
Hospira, Inc. is the labeler of record for COPPER. 4 FDA label records share the active ingredient CUPRIC CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does COPPER come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is COPPER prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CUPRIC CHLORIDE?
Yes. 4 FDA drug label records list CUPRIC CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has COPPER been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.