pharmacopeia

Edetate Calcium

Chelating ActivityIncreased Renal Ion ExcretionUS-FDASourced from openFDA
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Boxed warning

Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded.

Mechanism of action

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Mechanism-of-action class: Chelating Activity.

Indications

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  • Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.

Contraindications

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  • Edetate calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.contraindicated

Dosage & administration

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When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of edetate calcium disodium for asymptomatic adults and pediatric patients whose blood lead level is < 70 mcg/dL but > 20 mcg/dL (World Health Organization recommended upper allowable level) is 1,000 mg/m 2 /day whether given via intravenous infusion or intramuscularly (see Surface Area Nomogram). For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m 2 every 24 hours for 5 days for patients with serum creatinine levels of 2 to 3 mg/dL, every 48 hours for 3 doses for patients with creatinine levels of 3 to 4 mg/dL, and once weekly for patients with creatinine levels above 4 mg/dL. These regimens may be repeated at one month intervals. 12 Edetate calcium disodium, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dL or clinical symptoms consistent with lead poisoning are present, it is recommended that edetate calcium disodium be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy. 14-18 Therapy of lead poisoning in adults and pediatric patients with edetate calcium disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals.

Warnings & precautions

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See Boxed Warning.

Adverse reactions

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The following adverse effects have been associated with the use of edetate calcium disodium: Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia. Cardiovascular: hypotension, cardiac rhythm irregularities. Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli. Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment. Nervous System: tremors, headache, numbness, tingling. Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst. Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy. Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash. Hematopoietic: transient bone marrow depression, anemia. Metabolic: zinc deficiency, hypercalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

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Pregnancy One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to edetate calcium disodium. 10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to edetate calcium disodium, which were prevented by simultaneous supplementation of dietary zinc. 11 There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

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Symptoms Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dL did not cause any ill effects. Edetate calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects (cerebral edema, renal tubular necrosis) appear to be associated with lead poisoning. Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of edetate calcium disodium may produce a more severe zinc deficiency. Treatment Cerebral edema should be treated with repeated doses of mannitol. Steroids enhance the renal toxicity of edetate calcium disodium in animals and, therefore, are no longer recommended. 7 Zinc levels must be monitored. Good urinary output must be maintained because diuresis will enhance drug elimination. It is not known if edetate calcium disodium is dialyzable.

Approval history

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  • May 3, 2023ANDAANDA216435Casper Pharma Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
41 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Airway Remodelling3073%
  2. 2Asthma3073%
  3. 3Atopy3073%
  4. 4Blood Immunoglobulin E Increased3073%
  5. 5Central Nervous System Mass3073%
  6. 6Chronic Sinusitis3073%
  7. 7Confusional State3073%
  8. 8Eosinophil Count Decreased3073%
  9. 9Eosinophil Count Increased3073%
  10. 10Eosinophilic Granulomatosis With Polyangiitis3073%
  11. 11Eosinophilic Myocarditis3073%
  12. 12Eosinophilic Pneumonia3073%
  13. 13Haematuria3073%
  14. 14Haemorrhage3073%
  15. 15Hypertension3073%

Literature

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Recent PubMed references pinned to Edetate Calcium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Edetate Calcium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Edetate Calcium work?
Mechanism-of-action class: Chelating Activity.
What is Edetate Calcium used for?
According to FDA labeling, Edetate Calcium carries indications including: Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Edetate Calcium?
Edetate Calcium is classified as Chelating Activity, Increased Renal Ion Excretion.
What are the brand names for Edetate Calcium?
Edetate Calcium is marketed under brand names including Calcium Disodium Versenate.
What are the contraindications for Edetate Calcium?
Edetate Calcium labeling lists contraindications including: Edetate calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.. Always consult the full prescribing information and a clinician.
Note. Data for edetate-calcium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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