EDETATE CALCIUM DISODIUM- edetate calcium disodium_injection

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 1 1 2 3,4 5 WARNINGS 6

Edetate calcium disodium injection 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.

DOSAGE 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 20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m 2 For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m 2 12 14-18 Add the total daily dose of edetate calcium disodium (1000 mg/m 2 The total daily dosage (1000 mg/m 2 Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores. 7, 9,12,13,18 edta-nomogram.
Intravenous Administration
Add the total daily dose of edetate calcium disodium (1000 mg/m 2
Intramuscular Administration
The total daily dosage (1000 mg/m 2

The following adverse effects have been associated with the use of edetate calcium disodium: Body as a Whole: Cardiovascular: Renal: Urinary: Nervous System: Gastrointestinal: Hepatic: Immunogenic: Hematopoietic: Metabolic: To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC at 1-844-5-CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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

Pregnancy
Category B 10 11
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when edetate calcium disodium is administered to a nursing woman.
Pediatric Use
Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, edetate calcium disodium is used in patients of all ages. The intramuscular route is preferred by some for young pediatric patients. In cases where the intravenous route is necessary, avoid rapid infusion. (See WARNINGS General Precautions DOSAGE AND ADMINISTRATION

There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of edetate calcium disodium in animals. 7 7

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.
WARNINGS
See boxed warning
Carcinogenesis,Mutagenesis, Impairment of Fertility
Long term animal studies have not been conducted with edetate calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility.
Labor and Delivery
Edetate calcium disodium has no recognized use during labor and delivery, and its effects during these processes are unknown.
OVERDOSAGE
Symptoms Treatment 7
Diagnostic Test
Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores. 7, 9,12,13,18
REFERENCES
1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylene diamine tetraacetate treatment of lead-poisoned children. J Pharmacol Exp Therapeu 1986; 239: 829en dash835. 2

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