CUPRIC CHLORIDE

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 AND ADMINISTRATION Cupric chloride injection contains 0.4 mg of 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 of copper is 0.3 mg/day to 0.5 mg/day. For pediatric patients, the suggested additive dosage of copper is 20 mcg/kg/day (0.05 mL/kg/day) up to a maximum of 500 mcg/day. This product is not appropriate for patients weighing less than 4 kg due to the inability to measure the appropriate amount of the product. Do not administer cupric chloride injection intramuscularly because the acidic pH of the solution may cause considerable tissue irritation. Cupric chloride injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. The solution contains no preservatives; discard the unused portion immediately after the admixture procedure is completed. Cupric chloride injection should be inspected visually for particulate matter and discoloration prior to administration. Do not use unless the solution is clear and the seal is intact. Cupric ion may degrade ascorbic acid in 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.

CONTRAINDICATIONS Cupric chloride injection is contraindicated in patients with hypersensitivity to copper (see WARNINGS: Hypersensitivity Reactions ).

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.

DESCRIPTION Cupric chloride injection USP, 0.4 mg/mL is a sterile, clear, colorless to light blue color, 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; 9 mg sodium chloride and water for injection. 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. Its molecular weight is 170.48 g/mol. The molecular formula is CuCl 2 • 2H 2 O and the structural formula is: Cupric chloride, USP is a blue to blue-green crystalline compound freely soluble in water, soluble in alcohol and slightly soluble in ether. Sodium chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration. 1

OVERDOSAGE Acute copper toxicity has been reported in patients with oral, intravenous, or subcutaneous administration. Clinical manifestations included metallic taste, nausea, vomiting, diarrhea, abdominal pain, neurological signs, such as encephalopathy and multi-organ failure involving kidney, liver, blood and cardiovascular systems, which may be fatal. Chelating agents, such as D-penicillamine, can be used for treatment of acute toxicity. Long-term administration of parenteral copper above the recommended dosage may result in significant accumulation of copper in the liver, brain and other tissues with possible organ damage (see WARNINGS: Hepatic Accumulation ).

HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/mL is supplied as follows: NDC 72603-351-01 10 mL Single-dose glass vial NDC 72603-351-25 Carton of 25 x 10 mL Single-dose glass vials Storage : Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Immacule Lifesciences Private Limited Village Thanthewal, Ropar Rd, Nalagarh Solan District, HP 174101, India To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Iss. 07/2024 PI-CUC-00-NS LEIA-311.00 10573