Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/ mL is available in packages as follows: NDC Strength Packaged 70069- 506 -25 4 mg/10 mL (0.4 mg/mL) 25 vials of 10 mL Store at 20 to 25°C (68 to 77°F). [See USP Contro l led Room Temperature.]; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-506-01 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Carton Label NDC 70069-506-25 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Image Image
- HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/ mL is available in packages as follows: NDC Strength Packaged 70069- 506 -25 4 mg/10 mL (0.4 mg/mL) 25 vials of 10 mL Store at 20 to 25°C (68 to 77°F). [See USP Contro l led Room Temperature.]
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-506-01 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Carton Label NDC 70069-506-25 Rx only Cupric Chloride Injection, USP 4 mg/10 mL (0.4 mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION. Image Image
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 • 2 H 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 semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
Indications & 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
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 & Precautions
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
None known.
Adverse Reactions
None known.
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