Dietary supplement: Oral: 2 mg daily. Maximum: 8 mg daily.
There are no dosage adjustments provided in the manufacturer's labeling. However, use caution; contains parenteral aluminum.
There are no dosage adjustments provided in the manufacturer's labeling. However, use caution; in patients with significant cholestasis or hepatic dysfunction, a dosage reduction (~50%) or discontinuation may be required (Ref).
Use caution. Start at the low end of dosing range.
(For additional information see "Copper supplements (including parenteral nutrition additive): Pediatric drug information")
Parenteral nutrition additive, maintenance requirement: Note: Higher doses may be needed in patients with deficiency and increased requirements.
Infants weighing <10 kg: IV: 20 mcg/kg/day (Ref).
Infants and Children weighing 10 to 40 kg: IV: 20 mcg/kg/day; maximum daily dose: 500 mcg/day (Ref).
Children and Adolescents weighing >40 kg: IV: 200 to 500 mcg/day (Ref).
There are no dosage adjustments provided in the manufacturer's labeling. However, use caution; parenteral product contains aluminum.
There are no dosage adjustments provided in the manufacturer's labeling. However, use caution; in patients with significant cholestasis or hepatic dysfunction, a dosage reduction (~50%) or discontinuation may be required (Ref); some reports suggest infants with cholestasis may become deficient when copper is reduced or eliminated from parenteral nutrition and indicated some patients may require higher doses; monitor copper levels (Ref).
There are no adverse reactions listed in the manufacturer’s labeling.
There are no contraindications listed in the manufacturer's labeling.
Disease-related concerns:
• Gastrointestinal fistulae: Patients with high output intestinal fistulae may require a larger dose than the recommended daily allowance (ASPEN 2002).
• Hepatic impairment: Use with caution in patients with hepatic impairment (eg, impaired biliary excretion or cholestatic liver disease).
• Wilson's disease: Administration not recommended.
Concurrent drug therapy issues:
• Parenteral nutrition preparation: Copper ion may degrade ascorbic acid in parenteral nutrition (PN) solutions. To avoid loss, add multivitamin additives to PN solutions immediately prior to infusion or add to separate PN solution container.
Dosage form specific issues:
• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register, 2002). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Generic: 0.4 mg/mL (10 mL)
Yes
Solution (Cupric Chloride Intravenous)
0.4 mg/mL (per mL): $3.14 - $3.81
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Micro-Cu: 0.4 mg/mL (10 mL)
IV: Must be diluted. Do not administer IM or by direct IV injection; acidic pH of the solution may cause tissue irritation.
Parenteral: Not for direct IV or IM injection; must be diluted prior to administration; due to its acidic pH, direct administration of 0.4 mg/mL solution may cause tissue irritation.
Dietary supplementation: Trace element added to parenteral nutrition (PN) to prevent copper deficiency; orally as a dietary supplement.
Cupric sulfate may be confused with calcium gluconate
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised.
Dietary reference intake (IOM 2001):
1 to 6 months: Adequate intake (AI): 200 mcg/day (~30 mcg/kg/day).
7 to 12 months: AI: 220 mcg/day (~24 mcg/kg/day).
1 to 3 years: Recommended dietary allowance (RDA): 340 mcg/day.
4 to 8 years: RDA: 440 mcg/day.
9 to 13 years: RDA: 700 mcg/day.
14 to 18 years: RDA: 890 mcg/day.
>18 years: RDA: 900 mcg/day.
Pregnancy: RDA: 1,000 mcg/day.
Lactation: RDA: 1,300 mcg/day.
Copper and/or ceruloplasmin serum concentrations in long-term parenteral nutrition patients (twice monthly) and patients with burns, cholestasis, hepatic failure, or high output gastrointestinal fistulas (ASPEN [Vanek 2012])
Serum levels: 100 to 200 mcg/dL (SI: 15.7 to 31.4 micromole/L).
Copper is an essential nutrient which serves as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. It also helps maintain normal rates of red and white blood cell formation and helps prevent development of deficiency symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferring formation, secondary iron deficiency and osteoporosis.
Excretion: Bile (primarily, 80%); intestinal wall (16%); urine (4%)