Cupric Sulfate Injection

Dosage form: injection, solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

STERILE, PYROGEN FREE, TRACE ELEMENT ADDITIVE

FOR IV USE AFTER DILUTION

(COPPER 0.4 mg/mL)

Cupric Sulfate Injection Description

Cupric Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Cupric Sulfate (Pentahydrate) 1.57 mg. It delivers elemental copper 0.4 mg/mL. The 10 mL vial is a single dose preservative free vial. Discard any unused portion.

Cupric Sulfate Injection - Clinical Pharmacology

Copper is essential 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. Scorbutic type bone changes seen in infants fed exclusively with copper-poor cow’s milk are believed due to decreased activity of ascorbate oxidase, a cuproenzyme.

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

Indications and Usage for Cupric Sulfate Injection

Cupric Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Contraindications

Cupric Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

Warnings

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 ...