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Pronunciation |
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(ED
e tate KAL see um dye SOW dee
um) |
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U.S. Brand
Names |
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Calcium Disodium
Versenate® |
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Generic
Available |
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No |
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Synonyms |
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Calcium Disodium Edetate; Calcium EDTA |
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Pharmacological Index |
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Chelating Agent |
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Use |
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Treatment of symptomatic acute and chronic lead poisoning or for symptomatic
patients with high blood lead levels; used as an aid in the diagnosis of lead
poisoning; possibly useful in poisoning by zinc, manganese, and certain heavy
radioisotopes |
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Pregnancy Risk
Factor |
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B |
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Contraindications |
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Severe renal disease, anuria |
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Warnings/Precautions |
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Potentially nephrotoxic; renal tubular acidosis and fatal nephrosis may
occur, especially with high doses; EKG changes may occur during therapy; do not
exceed recommended daily dose; avoid rapid I.V. infusion in the management of
lead encephalopathy, may increase intracranial pressure to lethal levels. If
anuria, increasing proteinuria, or hematuria occurs during therapy, discontinue
calcium EDTA. Minimize nephrotoxicity by adequate hydration, establishment of
good urine output, avoidance of excessive doses, and limitation of continuous
administration to less than or equal to 5 days. |
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Adverse
Reactions |
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Percentage unknown: Anemia, anorexia, arrhythmias, arthralgia, cheilosis,
chills, EKG changes, fever, GI upset, headache, hypercalcemia, hypotension,
lacrimation, microscopic hematuria, mild increase in liver function tests, nasal
congestion, nausea, numbness, pain at injection site following I.M. injection,
paresthesia, proteinuria, renal tubular necrosis, skin lesions, sneezing,
thrombophlebitis following I.V. infusion (when concentration >5 mg/mL),
transient marrow suppression, tremor, vomiting, zinc
deficiency |
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Drug
Interactions |
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Decreased effect: Do not use simultaneously with zinc insulin preparations;
do not mix in the same syringe with dimercaprol |
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Stability |
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Dilute with 0.9% sodium chloride or D5W; physically
incompatible with D10W, LR, Ringer's |
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Mechanism of
Action |
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Calcium is displaced by divalent and trivalent heavy metals, forming a
nonionizing soluble complex that is excreted in urine |
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Pharmacodynamics/Kinetics |
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Absorption: I.M., S.C.: Well absorbed
Distribution: Into extracellular fluid; minimal CSF penetration
Half-life, plasma: I.M.: 1.5 hours; I.V.: 20 minutes
Elimination: Rapidly excreted in urine as metal chelates or unchanged drug,
decreased GFR decreases elimination; when administered I.V., urinary excretion
of chelated lead begins in 1 hour and peak excretion of chelated lead occurs
within 24-48 hours |
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Usual Dosage |
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Several regimens have been recommended:
Children: 500 mg/m2/dose, (maximum dose: 1 g) as a single dose or
divided into 2 doses
Adults: 500 mg/m2/dose
Note: Urine is collected for 24 hours after first EDTA dose and
analyzed for lead content; if the ratio of mcg of lead in urine to mg calcium
EDTA given is >1, then test is considered positive; for convenience, an
8-hour urine collection may be done after a single 50 mg/kg I.M. (maximum dose:
1 g) or 500 mg/m2 I.V. dose; a positive test occurs if the ratio of
lead excretion to mg calcium EDTA >0.5-0.6.
Treatment of lead poisoning: Children and Adults (each regimen is specific
for route):
Symptoms of lead encephalopathy and/or blood lead level >70 mcg/dL: Treat
5 days; give in conjunction with dimercaprol; wait a minimum of 2 days with no
treatment before considering a repeat course:
I.M.: 250 mg/m2/dose every 4 hours
I.V.: 50 mg/kg/day as 24-hour continuous I.V. infusion or 1-1.5
g/m2 I.V. as either an 8- to 24-hour infusion or divided into 2 doses
every 12 hours
Symptomatic lead poisoning without encephalopathy or
asymptomatic with blood lead level >70 mcg/dL: Treat 3-5 days; treatment with
dimercaprol is recommended until the blood lead level concentration <50
mcg/dL:
I.M.: 167 mg/m2 every 4 hours
I.V.: 1 g/m2 as an 8- to 24-hour infusion or divided every 12
hours
Asymptomatic children with blood lead level 45-69 mcg/dL: I.V.: 25
mg/kg/day for 5 days as an 8- to 24-hour infusion or divided into 2 doses every
12 hours
Depending upon the blood lead level, additional courses may be necessary;
repeat at least 2-4 days and preferably 2-4 weeks apart
Adults with lead nephropathy: An alternative dosing regimen reflecting the
reduction in renal clearance is based upon the serum creatinine. Refer to the
following:
Dose of Ca EDTA based on serum creatinine:
Scr less than or equal to 2 mg/dL: 1 g/m2/day for 5
days*
Scr 2-3 mg/dL: 500 mg/m2/day for 5 days*
Scr 3-4 mg/dL: 500 mg/m2/dose every 48 hours for 3
doses*
Scr >4 mg/dL: 500 mg/m2/week*
*Repeat these regimens monthly until lead excretion is reduced toward normal.
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Administration |
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For intermittent I.V. infusion, administer the dose I.V. over at least 1 hour
in asymptomatic patients, 2 hours in symptomatic patients; for I.V. continuous
infusion, dilute to 2-4 mg/mL in D5W or normal saline and infuse over
at least 8 hours, usually over 12-24 hours; for I.M. injection, 1 mL of 1%
procaine hydrochloride may be added to each mL of EDTA calcium to minimize pain
at injection site |
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Monitoring
Parameters |
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BUN, creatinine, urinalysis, I & O, and EKG during therapy; intravenous
administration requires a cardiac monitor, blood and urine lead
concentrations |
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Test
Interactions |
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If calcium EDTA is given as a continuous I.V. infusion, stop the infusion for
at least 1 hour before blood is drawn for lead concentration to avoid a falsely
elevated value |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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You will most likely require frequent blood tests and monitoring during
therapy. Report pain at injection/infusion site, palpitations, or difficulty
urinating. You must remain supine for a period of time following treatment,
change position slowly, ask for assistance if you must get up. Inform prescriber
if you are pregnant. Do not breast-feed. |
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Dosage Forms |
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Injection: 200 mg/mL (5 mL) |
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References |
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American Academy of Pediatrics Committee on Drugs,
"Treatment Guidelines for Lead Exposure in Children," Pediatrics, 1995,
96(1 Pt 1):155-60.
Moel DI and Kumar K,
"Reversible Nephrotic Reactions to a Combined 2,3-Dimercapto-1-propanol and Calcium Disodium Ethylenediaminetetraacetic Acid Regimen in Asymptomatic Children With Elevated Blood Lead Levels,"
Pediatrics, 1982, 70(2):259-62.
Osterloh J and Becker CE,
"Pharmacokinetics of CaNa2 EDTA and Chelation of Lead in Renal Failure,"
Clin Pharmacol Ther, 1986, 40(6):686-93.
"Treatment Guidelines for Lead Exposure in Children. American Academy of Pediatrics Committee on Drugs,"
Pediatrics, 1995, 96(1 Pt 1):155-60.
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