FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Cupric Sulfate Manufacturers
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American Regent, Inc.
Cupric Sulfate | American Regent, Inc.
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.
Use in PregnancySafety for use in pregnancy has not been established. Use of copper in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
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