CUPRIC CHLORIDE .4 mg/mL
CUPRIC CHLORIDE · INJECTION, SOLUTION · Archis Pharma LLC
CUPRIC CHLORIDE is a injection, solution containing cupric chloride at .4 mg/mL, taken intravenous. Manufactured by Archis Pharma LLC.
Key Facts
- Brand Name
- CUPRIC CHLORIDE
- Generic Name
- CUPRIC CHLORIDE
- NDC Code (Product)
72819-234- Manufacturer
- Archis Pharma LLC
- Strength
- .4 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217626
- Marketing Start
- 10/01/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Cupric Chloride Injection, USP 0.4 mg/mL 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 .)
Warnings
WARNINGS 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.
Contraindications
CONTRAINDICATIONS None known.
Adverse Reactions
ADVERSE REACTIONS None known.
Frequently Asked Questions
What is CUPRIC CHLORIDE used for?
CUPRIC CHLORIDE contains CUPRIC CHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is CUPRIC CHLORIDE a controlled substance?
CUPRIC CHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for CUPRIC CHLORIDE?
The generic name for CUPRIC CHLORIDE is CUPRIC CHLORIDE. There are 2 other brand versions of CUPRIC CHLORIDE.
What is the NDC code for CUPRIC CHLORIDE .4 mg/mL?
The NDC (National Drug Code) for CUPRIC CHLORIDE .4 mg/mL is 72819-234, listed by Archis Pharma LLC.