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Copper

Generic name: copper topical

Brand names: ParaGard

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral [preservative free]:

Cu-5: 5 mg [dye free]

Solution, Intravenous:

Generic: 0.4 mg/mL (10 mL)

Tablet, Oral:

Coppermin: 5 mg [corn free, rye free, wheat free]

Pharmacology

Mechanism of Action

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.

Pharmacokinetics/Pharmacodynamics

Excretion

Bile (primarily, 80%); intestinal wall (16%); urine (4%)

Use: Labeled Indications

Trace element added to parenteral nutrition (PN) to prevent copper deficiency; orally as a dietary supplement

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosage and Administration

Dosing: Adult

Parenteral nutrition additive, maintenance requirement (ASPEN [Vanek 2012]): IV: 0.3 to 0.5 mg/day

High output intestinal fistula: Some clinicians may use twice the recommended daily allowance (ASPEN 2002)

Dosing: Geriatric

Use caution. Start at the low end of dosing range.

Dosing: Pediatric

Parenteral nutrition additive, maintenance requirement (ASPEN [Corkins 2015]; ASPEN [Mirtallo 2004]; ASPEN [Vanek 2012]): Note: Higher doses may be needed in patients with deficiency and increased requirements. IV:

Infants <10 kg: 20 mcg/kg/day

Infants and Children weighing 10 to 40 kg: 5 to 20 mcg/kg/day; maximum daily dose: 500 mcg/day

Children and Adolescents weighing >40 kg: 200 to 500 mcg/day

Reconstitution

IV: Must dilute in a volume ≥100 mL.

Administration

IV: Must be diluted. Do not administer IM or by direct IV injection; acidic pH of the solution may cause tissue irritation.

Dietary Considerations

Dietary adequate intake (AI) (IOM 2001):

1 to 6 months of age: 200 mcg/day (~30 mcg/kg/day)

7 to 12 months of age: 220 mg/day (~24 mcg/kg/day)

Dietary recommended daily allowances (RDA) (IOM 2001):

1 to 3 years of age: 340 mcg/day

4 to 8 years of age: 440 mcg/day

9 to 13 years of age: 700 mcg/day

14 to 18 years of age: 890 mcg/day

>18 years: 900 mcg/day

Pregnancy: 1,000 mcg/day

Lactation: 1,300 mcg/day

Storage

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).

Drug Interactions

Ascorbic Acid: Copper may decrease the serum concentration of Ascorbic Acid. Management: To minimize the risk for ascorbic acid degradation, add multivitamin product to TPN solution immediately prior to infusion or administer multivitamin and copper in separate containers. Consider therapy modification

Adverse Reactions

Generally well tolerated; excessive copper levels may result in the following adverse effect.

Hepatic: Hepatic insufficiency (including hepatic necrosis)

Warnings/Precautions

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:

  • TPN preparation: Copper ion may degrade ascorbic acid in TPN solutions. To avoid loss, add multivitamin additives to TPN solutions immediately prior to infusion or add to separate TPN 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.

Monitoring Parameters

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])

Pregnancy

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Patient Education

  • Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
  • Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Source: Wolters Kluwer Health. Last updated August 19, 2019.