EDETATE CALCIUM DISODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EDETATE CALCIUM DISODIUM (EDETATE CALCIUM DISODIUM).
Chelates heavy metals (e.g., lead, cadmium) by forming stable complexes with divalent and trivalent cations, which are then excreted in urine.
| Metabolism | Not metabolized; excreted unchanged in urine, primarily via glomerular filtration. |
| Excretion | Primarily renal (90-100% as chelated lead complex within 24-48 hours); minimal biliary/fecal excretion (<5%). |
| Half-life | Terminal elimination half-life approximately 1.5-3 hours for the intact chelate; prolonged to 20-40 hours in lead-intoxicated patients due to redistribution of lead from bone. |
| Protein binding | Negligible (<5%); primarily binds lead in extracellular fluid. |
| Volume of Distribution | 0.3-0.5 L/kg (confined mainly to extracellular space; does not penetrate cells or CNS). |
| Bioavailability | IV or IM: 100% (not absorbed orally). |
| Onset of Action | IV: Immediate chelation of lead in plasma; IM: 30-60 minutes; no oral absorption. |
| Duration of Action | Duration of chelation effect is 6-12 hours per dose; repeated dosing required for sustained lead mobilization. |
Edetate calcium disodium is administered intravenously or intramuscularly. For lead poisoning: 1000 mg/m²/day IV continuous infusion or in divided doses every 12 hours; alternatively 50 mg/kg/day IV or IM in divided doses every 8-12 hours. Maximum 3000 mg/day. Duration typically 5 days, repeat after 2 days rest. For other heavy metal toxicity: 50 mg/kg/day IV or IM in divided doses every 8-12 hours for 3-5 days.
| Dosage form | INJECTABLE |
| Renal impairment | GFR > 50 mL/min: no adjustment. GFR 30-50 mL/min: reduce dose by 50%. GFR 15-29 mL/min: reduce dose by 75%. GFR < 15 mL/min or dialysis: contraindicated or use with extreme caution at 10-20% of normal dose with monitoring. |
| Liver impairment | No specific guidelines for Child-Pugh based modifications. Use with caution in severe hepatic impairment due to potential for electrolyte disturbances and nephrotoxicity. |
| Pediatric use | For lead poisoning: 1000 mg/m²/day IV continuous infusion or in divided doses every 12 hours; or 50 mg/kg/day IV or IM in divided doses every 8-12 hours. Maximum 3000 mg/day. Course: 5 days, may repeat after 2 days rest. For other indications: weight-based dosing similar to adults (50 mg/kg/day). |
| Geriatric use | Start at low end of dosing range (e.g., 30-40 mg/kg/day) due to age-related decreased renal function. Monitor renal function and electrolytes closely. Avoid use in patients with pre-existing renal impairment without dose reduction. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EDETATE CALCIUM DISODIUM (EDETATE CALCIUM DISODIUM).
| Breastfeeding | It is not known whether edetate calcium disodium is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. No M/P ratio has been reported. |
| Teratogenic Risk | FDA Pregnancy Category C. In animal studies, edetate calcium disodium has been shown to be teratogenic (skeletal anomalies) at doses approximately 0.25 times the human dose. There are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. First trimester: Risk cannot be ruled out; potential for teratogenic effects. Second and third trimesters: Potential fetal toxicity from chelation of essential minerals; avoid use unless necessary. |
■ FDA Black Box Warning
Black box warning for nephrotoxicity, particularly at high doses; may cause fatal renal failure. Avoid in patients with renal disease unless benefits outweigh risks. Monitor renal function closely during therapy.
| Serious Effects |
["Severe renal disease or anuria.","Acute pancreatitis.","Known hypersensitivity to edetate calcium disodium or any component.","Concurrent use with other nephrotoxic drugs.","Pregnancy (only if clearly needed due to risk to fetus from metal poisoning)."]
| Precautions | ["Nephrotoxicity - monitor BUN, creatinine, and urinalysis at baseline and during therapy.","Neurotoxicity - may cause tremors, myoclonus, and seizures, especially with high doses.","Hepatotoxicity - monitor liver function tests.","Arrhythmias - may cause QT prolongation; monitor ECG.","Hypocalcemia - monitor serum calcium levels; may cause tetany.","Use with caution in patients with asthma or allergic history.","Not recommended for prophylaxis of heavy metal poisoning."] |
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| Fetal Monitoring | Monitor serum calcium, magnesium, and zinc levels during therapy due to chelation of essential divalent cations. Monitor renal function (BUN, serum creatinine, urinalysis) before and during treatment because the drug is nephrotoxic. Obtain baseline and periodic ECG due to potential hypocalcemia-induced QT prolongation. Monitor for signs of tetany or seizures in both mother and fetus. Assess fetal growth and well-being with ultrasound if prolonged therapy is required. |
| Fertility Effects | No specific human studies on fertility. Animal studies have not been reported. However, chelation of essential metals like zinc may potentially affect spermatogenesis and oocyte maturation. Chronic use may impair fertility due to depletion of trace elements. |