cupric chloride

FDA Drug Profile — CUPRIC CHLORIDE

cupric chloride is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including CUPRIC CHLORIDE. Available dosage form: injection, solution.

Drug Details

Generic Name
cupric chloride
Brand Names
CUPRIC CHLORIDE
Application Number
ANDA212071
Sponsor
Exela Pharma Sciences, LLC
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
CUPRIC CHLORIDE

Indications and Usage

INDICATIONS AND USAGE Cupric chloride injection, USP 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.

Warnings

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.