CUPRIC CHLORIDE INJECTION, USP – solution

Cupric Chloride Injection, USP

0.4 mg/mL

FOR I.V. USE ONLY AFTER DILUTION

• Plastic Vial

R_x only

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 (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 vial is fabricated from cyclic olefin copolymer.

Copper is an essential nutrient which serves as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation.

Providing copper during TPN helps prevent development of the following deficiency symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation, secondary iron deficiency and osteoporosis.

Normal serum copper values range from 80 to 163 mcg/dl (mean, approximately 110 mcg/dl). The serum copper level at which deficiency symptoms appear is not precisely defined. A serum value of 9 mcg copper/dl was reported for one TPN patient who received no copper. The daily turnover of copper through ceruloplasmin is approximately 0.5 mg. Excretion of copper is through the bile (80%), directly through the intestinal wall (16%) and in urine (4%).

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.

None known.

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.

None known.

None known.

Copper toxicity can produce prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. Such symptoms have been reported with a serum copper level of 286 mcg/dl. Copper toxicity can also result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. D-penicillamine has been reported effective as an antidote.

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.)

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

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

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

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