pharmacopeia

Cupric Chloride

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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Electrolyte Activity.

Indications

Sourced from openFDA
  • Cupric chloride injection 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Contraindications

Sourced from openFDA
  • None known.contraindicated

Dosage & administration

Sourced from openFDA

Cupric Chloride Injection, USP 0.4 mg/mL contains 0.4 mg copper/mL and is administered intravenously only after dilution. The additive should be diluted in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage is 0.5 to 1.5 mg copper/day (1.25 to 3.75 mL/day). For pediatric patients, the suggested additive dosage is 20 mcg copper/kg/day (0.05 mL/kg/day). Infants weighing less than 1500 gm may have increased requirements because of their low body reserves and increased requirements for growth. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

Warnings & precautions

Sourced from openFDA

Direct intramuscular or intravenous injection of Cupric chloride injection 0.4 mg/mL is contraindicated, as the acidic pH of the solution (2) may cause considerable tissue irritation. Liver and/or biliary tract dysfunction may require omission or reduction of copper and manganese doses because these elements are primarily eliminated in the bile. WARNING: 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.

Adverse reactions

Sourced from openFDA

None known.

Overdosage

Sourced from openFDA

Copper toxicity can produce prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. Such symptoms have been reported with a serum copper level of 286 mcg/dl. Copper toxicity can also result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. D- penicillamine has been reported effective as an antidote.

Approval history

Sourced from openFDA
  • Jun 26, 1986NDANDA018960Hospira
  • Oct 31, 2022ANDAANDA212071Exela Pharma
  • Apr 30, 2024ANDAANDA217626Stira
  • Apr 30, 2024ANDAANDA216113Somerset
  • Jan 26, 2026ANDAANDA217287Amneal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
715 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue7210%
  2. 2Off Label Use679.4%
  3. 3Headache618.5%
  4. 4Nausea588.1%
  5. 5Pain588.1%
  6. 6Diarrhoea578.0%
  7. 7Drug Ineffective476.6%
  8. 8Weight Decreased476.6%
  9. 9Malaise405.6%
  10. 10Abdominal Pain385.3%
  11. 11Dizziness375.2%
  12. 12Anaemia354.9%
  13. 13Dyspnoea334.6%
  14. 14Constipation304.2%
  15. 15Urinary Tract Infection294.1%

Literature

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Recent PubMed references pinned to Cupric Chloride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Frequently asked questions

How does Cupric Chloride work?
Mechanism-of-action class: Electrolyte Activity.
What is Cupric Chloride used for?
According to FDA labeling, Cupric Chloride carries indications including: Cupric chloride injection 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cupric Chloride?
Cupric Chloride is classified as Electrolyte Activity, Cellular Activity Alteration.
What are the contraindications for Cupric Chloride?
Cupric Chloride labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for cupric-chloride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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