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Edetate Calcium Disodium
Pronunciation
U.S. Brand Names
Generic Available
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Administration
Monitoring Parameters
Test Interactions
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Dosage Forms
References

Pronunciation
(ED e tate KAL see um dye SOW dee um)

U.S. Brand Names
Calcium Disodium Versenate®

Generic Available

No


Synonyms
Calcium Disodium Edetate; Calcium EDTA

Pharmacological Index

Chelating Agent


Use

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


Pregnancy Risk Factor

B


Contraindications

Severe renal disease, anuria


Warnings/Precautions

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.


Adverse Reactions

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


Drug Interactions

Decreased effect: Do not use simultaneously with zinc insulin preparations; do not mix in the same syringe with dimercaprol


Stability

Dilute with 0.9% sodium chloride or D5W; physically incompatible with D10W, LR, Ringer's


Mechanism of Action

Calcium is displaced by divalent and trivalent heavy metals, forming a nonionizing soluble complex that is excreted in urine


Pharmacodynamics/Kinetics

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


Usual Dosage

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.


Administration

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


Monitoring Parameters

BUN, creatinine, urinalysis, I & O, and EKG during therapy; intravenous administration requires a cardiac monitor, blood and urine lead concentrations


Test Interactions

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


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

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.


Dosage Forms

Injection: 200 mg/mL (5 mL)


References

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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