Drug Facts
Composition & Profile
Identifiers & Packaging
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; Principal Display Panel Text for Container Label: NDC 72603- 351 -01 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) 10 mL Single-dose Vials Rx only Principal Display Panel Text for Carton Label: NDC 72603- 351 -25 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) 10 mL Single-dose vials in package of 25 Rx only viallabel cartonlabel
- 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
- Principal Display Panel Text for Container Label: NDC 72603- 351 -01 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) 10 mL Single-dose Vials Rx only Principal Display Panel Text for Carton Label: NDC 72603- 351 -25 Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) 10 mL Single-dose vials in package of 25 Rx only viallabel cartonlabel
Overview
Cupric Chloride Injection, USP 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/or 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.
Indications & Usage
Cupric chloride injection, USP is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Dosage & Administration
Cupric Chloride Injection 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 & Precautions
WARNINGS Direct intramuscular or intravenous injection of cupric chloride injection 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.
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