FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Direct intramuscular or intravenous injection of Copper 0.4 mg/mL (Cupric Chloride Injection, USP) 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
History
There is currently no drug history available for this drug.
Other Information
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 1.07 mg cupric chloride, dihydrate and 9 mg sodium chloride.
The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.327 m0smol/mL (calc.).
Cupric chloride, USP is chemically designated cupric chloride, dihydrate (CuCl2• 2H2O), a crystalline compound freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
Sources
Copper Manufacturers
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Hospira, Inc.
Copper | Hospira, Inc.
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) contains 0.4 mg copper/mL and is administered intravenously only after dilution. The additive should be diluted in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage is 0.5 to 1.5 mg copper/day (1.25 to 3.75 mL/day). For pediatric patients, the suggested additive dosage is 20 mcg copper/kg/day (0.05 mL/kg/day). Infants weighing less than 1500 gm may have increased requirements because of their low body reserves and increased requirements for growth.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
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