FDA
Cupric Chloride
The FDA lists this product in 4 strengths and forms.
Indications
Cupric chloride injection 0.4 mg/mL 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.
Contraindications
None known.
Warnings and precautions
Direct intramuscular or intravenous injection of Cupric chloride injection 0.4 mg/mL 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.
Composition
- Active ingredients
- CUPRIC CHLORIDE EQ 0.4MG COPPER/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Cupric Chloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Somerset
- Status
- Prescription
- FDA approval
- 30 Apr 2024
- Application
- ANDA216113-001



