Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3122
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CHROMIUM 4 (Injection, Solution)
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| dailymed-instance:dosage |
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) contains
4 mcg chromium/mL and is administered intravenously only after dilution. The
additive should be administered in a volume of fluid not less than 100 mL.
For the adult receiving TPN, the suggested additive dosage is 10 to 15
mcg chromium/day (2.5 to 3.75 mL/day). The metabolically stable adult with
intestinal fluid loss may require 20 mcg chromium/day (5 mL/day), with frequent
monitoring of blood levels as a guideline for subsequent administration. For
pediatric patients, the suggested additive dosage is 0.14 to 0.20 mcg/kg/day
(0.035 to 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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| dailymed-instance:descripti... |
Chromium 4 mcg/mL (Chromic 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
20.5 mcg chromic chloride, hexahydrate 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/or sodium hydroxide
for pH adjustment. The osmolarity is 0.308 mOsm/mL (calc.). Chromic
Chloride, USP is chemically designated chromic chloride, hexahydrate CrCl���6HO, a crystalline compound 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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Trivalent chromium is part of glucose tolerance factor, an
essential activator of insulin-mediated reactions. Chromium helps to maintain
normal glucose metabolism and peripheral nerve function. Providing
chromium during TPN helps prevent deficiency symptoms including impaired glucose
tolerance, ataxia, peripheral neuropathy and a confusional state similar to
mild/moderate hepatic encephalopathy. Serum chromium
is bound to transferrin (siderophilin) in the beta globulin fraction. Typical
blood levels for chromium range from 1 to 5 mcg/liter, but blood levels are
not considered a meaningful index of tissue stores. Administration of chromium
supplements to chromium-deficient patients can result in normalization of
the glucose tolerance curve from the diabetic-like curve typical of chromium
deficiency. This response is viewed as a more meaningful indicator of chromium
nutriture than serum chromium levels. Excretion of
chromium is via the kidneys, ranging from 3 to 50 mcg/day. Biliary excretion
via the small intestine may be an ancillary route, but only small amounts
of chromium are believed to be excreted in this manner.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None known.
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| dailymed-instance:supply |
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is supplied
in 10 mL Plastic Vials (List No. 4093). Store at 20
to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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| dailymed-instance:precautio... |
General: Do not use unless solution is clear and seal is intact. Chromium
4 mcg/mL (Chromic 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. In
assessing the contribution of chromium supplements to maintenance of glucose
homeostasis, consideration should be given to the possibility that the patient
may be diabetic.<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. This drug is known to
be substantially excreted by the kidney, and the risk of toxic reactions to
this drug may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should
be taken in dose selection, and it may be useful to monitor renal function.<br/>Laboratory Tests: Because chromium is present in the bloodstream in microgram
quantities, routine measurement is impractical. If necessary, samples can
be sent to a reference laboratory for assay.<br/>Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies to evaluate the carcinogenic potential
of Chromium 4 mcg/mL (Chromic 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 Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is administered to
a nursing woman.<br/>Pediatric Use: See DOSAGE and ADMINISTRATION section. Safety and effectiveness
in children have not been established.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
chromic chloride. It is also not known whether chromic chloride can cause
fetal harm when administered to a pregnant woman or can affect reproductive
capacity. Chromic chloride should be given to a pregnant woman only if clearly
indicated.
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Trivalent chromium administered intravenously to TPN patients
has been shown to be nontoxic when given at dosage levels of up to 250 mcg/day
for two consecutive weeks. Reported toxic reactions
to chromium include nausea, vomiting, ulcers of the gastrointestinal tract,
renal and hepatic damage, convulsions and coma. The acute LDfor
intravenous trivalent chromium in rats was reported as 10 to 18 mg/kg.
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| dailymed-instance:genericMe... |
Chromic Chloride
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CHROMIUM 4 (Injection, Solution)
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| dailymed-instance:adverseRe... |
None known.
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| dailymed-instance:warning |
Direct intramuscular or intravenous injection of Chromium
4 mcg/mL (Chromic Chloride Injection, USP) is contraindicated, as the acidic
pH of the solution may cause considerable tissue irritation. Severe
kidney disease may make it necessary to reduce or omit chromium and zinc doses
because these elements are primarily eliminated in the urine. 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.
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| dailymed-instance:indicatio... |
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated
for use as a supplement to intravenous solutions given for total parenteral
nutrition (TPN). Administration helps to maintain chromium serum levels and
to prevent depletion of endogenous stores and subsequent deficiency symptoms.
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CHROMIUM 4
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