Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2746
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COPPER (Injection, Solution)
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| dailymed-instance:dosage |
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) 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.
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| dailymed-instance:descripti... |
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) 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, USP is chemically designated cupric chloride, dihydrate (CuCl���2HO), a crystalline compound freely soluble in water. Sodium
Chloride, USP 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.
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| dailymed-instance:clinicalP... |
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, secondary iron deficiency and osteoporosis. 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%).
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None known.
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| dailymed-instance:supply |
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is supplied
in 10 mL Plastic Vials (List No. 4092). Store at controlled
room temperature 15��to 30��C (59��to 86��F) [See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
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. Copper
0.4 mg/mL (Cupric Chloride Injection, USP) 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.<br/>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.<br/>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.<br/>Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies to evaluate the carcinogenic
potential of Copper 0.4 mg/mL (Cupric Chloride Injection, USP) have not been
performed, nor have studies been done to assess mutagenesis or impairment
of fertility.<br/>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 Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is administered to
a nursing woman.<br/>Pediatric Use: See DOSAGE and ADMINISTRATION section. There are limited
data in infants weighing less than 1500 grams.<br/>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.<br/>Geriatric Use: An evaluation of current literature revealed no clinical
experience identifying differences in response between elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
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| dailymed-instance:overdosag... |
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.
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| dailymed-instance:genericMe... |
Cupric Chloride
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| dailymed-instance:fullName |
COPPER (Injection, Solution)
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| dailymed-instance:adverseRe... |
None known.
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| dailymed-instance:warning |
Direct intramuscular or intravenous injection of Copper 0.4
mg/mL (Cupric Chloride Injection, USP) 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 parentaral 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.
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| dailymed-instance:indicatio... |
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) 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.
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| dailymed-instance:name |
COPPER
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