Edetate disodium

Edetate disodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

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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.