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Pronunciation:

(ED e tate dye SOW dee um)

U.S. Brand Names:

Endrate®

Synonyms:

Edathamil Disodium; EDTA; Sodium Edetate

Generic Available:

Yes

Use:

Emergency treatment of hypercalcemia; control digitalis-induced cardiac dysrhythmias (ventricular arrhythmias)

Pregnancy Risk Factor:

Contraindications:

Severe renal failure or anuria

Warnings/Precautions:

Use of this drug is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy; use with caution in patients with renal dysfunction, intracranial lesions, seizure disorders, coronary or peripheral vascular disease

Adverse Reactions:

Rapid I.V. administration or excessive doses may cause a sudden drop in serum calcium concentration which may lead to hypocalcemic tetany, seizure, arrhythmia, and death from respiratory arrest. Do not exceed recommended dosage and rate of administration.

1% to 10%: Gastrointestinal: Nausea, vomiting, abdominal cramps, diarrhea

<1%: Arrhythmias, transient hypotension, acute tubular necrosis, seizure, fever, headache, tetany, chills, eruptions, dermatologic lesions, hypomagnesemia, hypokalemia, anemia, thrombophlebitis, pain at the site of injection, paresthesia may occur, back pain, muscle cramps, nephrotoxicity, death from respiratory arrest

Overdosage/Toxicology:

Symptoms of overdose include hypotension, dysrhythmias, tetany, seizures

Treatment includes immediate I.V. calcium salts for hypocalcemia related adverse reactions; replace calcium cautiously in patients on digitalis

Drug Interactions:

Increased effect of insulin (edetate disodium may decrease blood glucose concentrations and reduce insulin requirements in diabetic patients treated with insulin)

Compatibility:

Stable in dextran 6% in dextrose, dextran 6% in NS, D5¹/4NS, D5¹/2NS, D5NS, D5W, D10W, D10NS, ¹/2NS, NS

Mechanism of Action:

Chelates with divalent or trivalent metals to form a soluble complex that is then eliminated in urine

Pharmacodynamics/Kinetics:

Metabolism: None

Half-life elimination: 20-60 minutes

Time to peak: I.V.: 24-48 hours

Excretion: Following chelation: Urine (95%); chelates within 24-48 hours

Dosage:

Hypercalcemia: I.V.:

Children: 40-70 mg/kg/day slow infusion over 3-4 hours or more to a maximum of 3 g/24 hours; administer for 5 days and allow 5 days between courses of therapy

Adults: 50 mg/kg/day over 3 or more hours to a maximum of 3 g/24 hours; a suggested regimen of 5 days followed by 2 days without drug and repeated courses up to 15 total doses

Digitalis-induced arrhythmias: Children and Adults: 15 mg/kg/hour (maximum dose: 60 mg/kg/day) as continuous infusion

Administration:

Parenteral: I.V.: Must be diluted before I.V. use in D5W or NS to a maximum concentration of 30 mg/mL (3%) and infused over at least 3 hours; avoid extravasation; not for I.M. use

Monitoring Parameters:

Cardiac function (ECG monitoring); blood pressure during infusion; renal function should be assessed before and during therapy; monitor calcium, magnesium, and potassium levels; cardiac monitor required

Dietary Considerations:

Sodium content of 1 g: 5.4 mEq

Patient Education:

Patient education and instruction will be determined by patient condition and ability to understand. You will require frequent blood tests and monitoring during this infusion. You must remain supine during infusion and for a period of time following treatment; change position slowly and ask for assistance if you must get up. Immediately report any respiratory difficulty, chest pain, or irregular heartbeat; headache, abdominal cramps, chills, back pain, or muscle rigidity or cramping; or pain at injection/infusion site. Inform prescriber if you are pregnant.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Injection, solution: 150 mg/mL (20 mL)

References

MacCara ME, "Extravasation - A Hazard of Intravenous Therapy,"Drug Intell Clin Pharm, 1983, 17:713.

Pfister RR, "Chemical Injuries of the Eye,"Ophthalmology, 1983, 90(10):1246-53.

"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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