CUPRIC CHLORIDE .4 mg/mL Injection, Solution — NDC 72819-234-99 (Billing 72819-0234-99)

WARNINGS Direct intramuscular or intravenous injection of cupric chloride injection 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 lower rates of administration.

ADVERSE REACTIONS None known.

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. 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.

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. 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. 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 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 cupric chloride injection is administered to a nursing woman. Pediatric Use ( See DOSAGE AND ADMINISTRATION Section.) There are limited data in infants weighing less than 1500 grams. 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.

DRUG ABUSE AND DEPENDENCE None known.