Edetate disodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
Edetate disodium is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Edetate disodium FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Edetate disodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Edetate disodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Edetate disodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Edetate disodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Edetate disodium in pediatric patients.
Contraindications
Endrate (Edetate Disodium Injection, USP) is contraindicated in anuric patients. It is not indicated for the treatment of generalized arteriosclerosis associated with advancing age.
Warnings
Rapid intravenous infusion or attainment of high serum concentration of edetate disodium may cause a precipitous drop in the serum calcium level and many result in fatality. Toxicity appears to be dependent upon both total dosage and speed of administration. The rate of administration and dosage should not exceed that indicated in DOSAGE AND ADMINISTRATION.
Because of its irritant effect on the tissues and because of the danger of serious side effects if administered in the undiluted form, Endrate (Edetate Disodium Injection, USP) should be diluted before infusion. See DOSAGE AND ADMINISTRATION. PRECAUTIONS After the infusion of edetate disodium, the patient should remain in bed for a short time because of the possibility of postural hypotension.
The possibility of an adverse effect on myocardial contractility should be considered when administering the drug to patients with heart disease. Caution is dictated in the use of this drug in patients with limited cardiac reserve or incipient congestive failure.
Edetate Disodium Injection, USP therapy should be used with caution in patients with clinical or subclinical potassium deficiency states. In such cases it is advisable to perform serum potassium blood levels for possible hypokalemia and to monitor ECG changes.
The possibility of hypomagnesemia should be kept in mind during prolonged therapy.
Treatment with edetate disodium has been shown to cause a lowering of blood sugar and insulin requirements in patients with diabetes who are treated with insulin.
Do not use unless solution is clear and container is intact. Discard unused portion.
Laboratory Test Renal excretory function should be assessed prior to treatment. Periodic BUN and creatinine determinations and daily urinalysis should be performed on patients receiving this drug.
Because of the possibility of inducing an electrolyte imbalance during treatment with edetate disodium, appropriate laboratory determinations and studies to evaluate the status of cardiac function should be performed. Repetition of these tests is recommended as often as clinically indicated, particularly in patients with ventricular arrhythmia and those with a history of seizure disorders or intracranial lesions. If clinical evidence suggests any disturbance of liver function during treatment, appropriate laboratory determinations should be performed and withdrawal of the drug may be required.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Edetate disodium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Edetate disodium Postmarketing Experience in the drug label.
Drug Interactions
The oxalate method of determining serum calcium tends to give low readings in the presence of edetate disodium; modification of this method, as by acidifying the sample or use of a different method may be required for accuracy. The least interference will be noted immediately before a subsequent dose is administered.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Edetate disodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Edetate disodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Edetate disodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Edetate disodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Edetate disodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Edetate disodium in geriatric settings.
Gender
There is no FDA guidance on the use of Edetate disodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Edetate disodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Edetate disodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Edetate disodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Edetate disodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Edetate disodium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Edetate disodium Administration in the drug label.
Monitoring
There is limited information regarding Edetate disodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Edetate disodium and IV administrations.
Overdosage
There is limited information regarding Edetate disodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Edetate disodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Edetate disodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Edetate disodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Edetate disodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Edetate disodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Edetate disodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Edetate disodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Edetate disodium How Supplied in the drug label.
Storage
There is limited information regarding Edetate disodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Edetate disodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Edetate disodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Edetate disodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Edetate disodium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.