CUPRIC CHLORIDE
CUPRIC CHLORIDE is an FDA drug label for the active ingredient CUPRIC CHLORIDE manufactured by Exela Pharma Sciences, LLC administered by INTRAVENOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20190516.
- Generic name
- CUPRIC CHLORIDE
- Manufacturer
- Exela Pharma Sciences, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Dosage form
- N/A
- NDC
- 51754-0103
- Application
- ANDA212071
- Label effective
- 20190516
Indications & Usage
INDICATIONS AND USAGE Cupric Chloride Injection, USP 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Cupric Chloride Injection, USP contains 0.4 mg/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 1,500 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 .)
Contraindications
CONTRAINDICATIONS None known.
Warnings
WARNINGS Direct intramuscular or intravenous injection of Cupric Chloride Injection, USP 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
ADVERSE REACTIONS None known.