Jane S. Ricciuti, RPh, MS

Disclosures

April 22, 2003

In This Article

Trace Elements

Manufacturer: Abbott Laboratories

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/06/03)

Warnings: This supplemental approval provides for the addition of the following text to the "Warnings" section of the product labeling for cupric chloride injection:

  • 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.

Cupric Chloride Injection Letter

Cupric Chloride Injection

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