COPPER

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.

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.

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

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.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Copper 0.4 mg/mL (Cupric Chloride Injection) is administered to a nursing woman.

ADVERSE REACTIONS None known.