Monograph: |
Cupric sulphate
The properties are the same as of Copper sulphate so see below at Copper sulphate record for the
details.
COPPER SULPHATE
Indications: Nutritional support
DESCRIPTION:
Cupric chloride injection is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each ml of solution contains 1.07 mg cupric chloride, dihydrate and 9 mg sodium chloride.
The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.327 m0smol/ml (calc.).
Cupric chloride is chemically designated cupric chloride, dihydrate (CuCl2Β·2H2O), a crystalline compound freely soluble in water.
Sodium chloride is chemically designated NaCl, a white crystalline compound freely soluble in water.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
CLINICAL PHARMACOLOGY:
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. Copper also helps maintain normal rates of red and white blood cell formation.
Providing Copper During TPN Helps Prevent Development of the Following Deficiency Symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency.
Normal serum copper values range from 80 to 163 mcg/dl (mean, approximately 110 mcg/dl). The serum copper level at which deficiency symptoms appear is not precisely defined. A serum value of 9 mcg copper/dl was reported for one TPN patient who received no copper. The daily turnover of copper through ceruloplasmin is approximately 0.5 mg. Excretion of copper is through the bile (80%), directly through the intestinal wall (16%) and in urine (4%).
INDICATIONS AND USAGE:
Cupric chloride injection 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:
None known.
WARNINGS:
Direct intramuscular or intravenous injection of cupric chloride injection 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.
PRECAUTIONS:
General
Do not use unless the solution is clear and the seal is intact.
Administration of zinc in the absence of copper may cause a decrease in serum copper levels.
Cupric chloride injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
It is not recommended to administer copper to a patient with Wilson's Disease, a genetic disease of copper metabolism.
Laboratory Tests
Twice monthly serum assays for copper and/or ceruloplasmin are suggested for monitoring copper concentrations in long-term TPN patients. As ceruloplasmin is a cuproenzyme, ceruloplasmin assays may be depressed secondary to copper deficiency.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of cupric chloride injection have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cupric chloride injection is administered to a nursing woman.
Pediatric Use
See DOSAGE AND ADMINISTRATION. Safety and effectiveness in pediatric patients have not been established.
Pregnancy Category C
Animal reproduction studies have not been conducted with cupric chloride. It is also not known whether cupric chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cupric chloride should be given to a pregnant woman only if clearly indicated.
DRUG INTERACTIONS:
Cupric ion may degrade ascorbic acid in total parenteral nutrition (TPN) solutions. In order to avoid this loss of ascorbate, multivitamin additives should be added to TPN solutions immediately prior to infusion. Alternatively, the multivitamin additive may be added to one container of TPN solution, followed by copper in a subsequent container.
ADVERSE REACTIONS:
None known.
DRUG ABUSE AND DEPENDENCE:
None known.
OVERDOSAGE:
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. D-penicillamine has been reported effective as an antidote.
DOSAGE AND ADMINISTRATION:
Cupric chloride injection 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).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
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