Rx Only

STERILE, PYROGEN FREE, TRACE ELEMENT ADDITIVE

FOR IV USE AFTER DILUTION

(COPPER 0.4 mg/mL)

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.

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

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 accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Administration of copper in the absence of zinc may cause a decrease in plasma zinc levels. Periodic determinations of plasma zinc as well as copper are suggested as a guideline for subsequent copper administration. As copper is eliminated via the bile, the possibility of copper retention should be considered in patients with biliary tract obstruction. Decreasing or omitting copper supplements entirely may be necessary in such patients.

ADVERSE REACTIONS

The amount of copper present in Cupric Sulfate Injection, USP is very small, symptoms from copper toxicity are considered unlikely to occur.

DOSAGE AND ADMINISTRATION

Cupric Sulfate Injection, USP provides 0.4 mg copper/mL. For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day.

Aseptic addition of Cupric Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Copper is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Weekly monitoring of copper plasma levels is suggested as a guideline for subsequent administration. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

OVERDOSAGE

Symptoms of copper toxicity reported in the literature include prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia, and peripheral edema. D-pencillamine has been reported effective as an antidote. Symptoms of overdosage from copper given at 1.5 mg/day are considered unlikely.

HOW SUPPLIED

Cupric Sulfate Injection, USP (0.4 mg/mL)

NDC 0517-6210-25       10 Ml SDV       packed in a box of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN6210

Rev. 1/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 10 mL Carton

CUPRIC SULFATE
INJECTION, USP

Copper 4 mg/10 mL (0.4 mg/mL)

Trace Element Additive

NDC 0517-6210-25

25 x 10 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

Each mL contains: Cupric Sulfate (Pentahydrate) 1.57 mg, Water for Injection q.s.

pH adjusted with Sulfuric Acid when necessary. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05