Cupric Chloride

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.

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

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.

Laboratory Tests Twice monthly serum assays for copper and/or ceruloplasmin are suggested for monitoring copper concentrations in long-term TPN patients. As ceruloplasmin is a cuproenzyme, ceruloplasmin assays may be depressed secondary to copper deficiency. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of Copper 0.4 mg/mL (Cupric Chloride Injection) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility. 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. Pediatric Use The safety and effectiveness of Cupric Chloride Injection have been established in pediatric patients receiving parenteral nutrition (see DOSAGE AND ADMINISTRATION ). 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. 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. Hepatic Impairment Copper is primarily excreted in the bile. Excretion is decreased in patients with cholestasis and/or cirrhosis (see CLINICAL PHARMACOLOGY ). Hepatic accumulation of copper has been reported with long-term administration of parenteral nutrition at dosages higher than recommended ( see WARNINGS: Hepatic Accumulation ). For patients with cholestasis 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 use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin.

None known.

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.

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.

The safety and effectiveness of Cupric Chloride Injection have been established in pediatric patients receiving parenteral nutrition (see DOSAGE AND ADMINISTRATION ).

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. Hepatic Impairment Copper is primarily excreted in the bile. Excretion is decreased in patients with cholestasis and/or cirrhosis (see CLINICAL PHARMACOLOGY ). Hepatic accumulation of copper has been reported with long-term administration of parenteral nutrition at dosages higher than recommended ( see WARNINGS: Hepatic Accumulation ). For patients with cholestasis 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 use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin.