Brand Name
Edetate
View Brand InformationFDA approval date: May 03, 2023
Classification: Lead Chelator
Form: Injection
What is Edetate?
Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
Approved To Treat
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Brand Information
Edetate Calcium Disodium (Edetate Calcium Disodium)
WARNINGS
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.
1DESCRIPTION
Edetate Calcium Disodium injection, USP is a sterile, injectable, chelating agent in concentrated solution for intravenous infusion or intramuscular injection. Each 5 mL single-dose vial contains 1,000 mg of edetate calcium disodium (equivalent to 200 mg/mL) in water for injection and sodium hydroxide (as pH adjuster). Chemically, this product is called [[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)-glycinato]](4-)-N,N',O,O',O
Structural Formula:
C10H12CaN2Na2O8 • × H2O
Molecular Weight: 374.27 (anhydrous)
2CLINICAL PHARMACOLOGY
The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals. A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury. The amounts of manganese and iron mobilized are not significant. Copper
3INDICATIONS AND USAGE
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.
4CONTRAINDICATIONS
Edetate calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.
5WARNINGS
See Boxed Warning.
6ADVERSE REACTIONS
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.
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.
7OVERDOSAGE
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.
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.
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.
8DOSAGE AND ADMINISTRATION
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
For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 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.
8.1Intravenous Administration
Add the total daily dose of edetate calcium disodium (1,000 mg/m
8.2Intramuscular Administration
The total daily dosage (1,000 mg/m
8.3Diagnostic Test
Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores.
9HOW SUPPLIED
Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
10REFERENCES
1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylene diamine tetraacetate treatment of lead-poisoned children.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816.
Made in India
Code No.: TN/DRUGS/616/1996
Revised: 01/2025
PIP58851-01
11PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 5 mL Single-dose Vial
Rising Pharma Holdings, Inc.
Edetate Calcium Disodium Injection, USP
1000 mg/5 mL (200 mg/mL)
NDC 64980-588-05
Rx only
NDC 64980-588-51
5 x 5 mL Single-dose Vials per carton
For intravenous or intramuscular administration only
Rx Only
