Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/mL is supplied in 10 mL plastic vials (NDC 51754-0103-1) available in a carton of 10 (NDC 51754-0103-3) and a carton of 25 (NDC 51754-0103-4). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645 Revised: 11/2022 Logo; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Vial Label Rx Only NDC 51754-0103-1 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 mL Single-dose Vial Vial Label; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-10 x 10 mL Vial Carton NDC 51754-0103-3 Rx Only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 x 10 mL Single-dose Vials 10 ct Carton; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-25 x 10 mL Vial Carton NDC 51754-0103-4 Rx Only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 25 x 10 mL Single-dose Vials 25 ct Carton
- HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/mL is supplied in 10 mL plastic vials (NDC 51754-0103-1) available in a carton of 10 (NDC 51754-0103-3) and a carton of 25 (NDC 51754-0103-4). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645 Revised: 11/2022 Logo
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Vial Label Rx Only NDC 51754-0103-1 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 mL Single-dose Vial Vial Label
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-10 x 10 mL Vial Carton NDC 51754-0103-3 Rx Only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 x 10 mL Single-dose Vials 10 ct Carton
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-25 x 10 mL Vial Carton NDC 51754-0103-4 Rx Only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 25 x 10 mL Single-dose Vials 25 ct Carton
Overview
Cupric Chloride Injection, USP 0.4 mg/mL 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 mOsmol/mL (calc.). Cupric Chloride, USP is chemically designated cupric chloride, dihydrate (CuCl 2 • 2H 2 O), a crystalline compound freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The vial is fabricated from cyclic olefin copolymer.
Indications & 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
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 .)
Warnings & Precautions
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.
Contraindications
None known.
Adverse Reactions
None known.
Drug Interactions
Cupric ion may degrade ascorbic acid in total parenteral nutrition (TPN) solutions. In order to avoid this loss of ascorbate, multivitamin additives should be added to TPN solutions immediately prior to infusion. Alternatively, the multivitamin additive may be added to one container of TPN solution, followed by copper in a subsequent container.
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