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.
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.
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).
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.
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.
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