Edetate (Endrate)
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Edetate (Endrate)

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

ENDRATE
(edetate disodium) Anhydrous Injection, Solution

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION
Ampul

WARNING

The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

DRUG DESCRIPTION

Endrate (Edetate Disodium Injection, USP) is a sterile, nonpyrogenic, concentrated solution of edetate disodium in water for injection which as a result of a pH adjustment with sodium hydroxide contains varying amounts of disodium and trisodium salts. After dilution, it is administered by intravenous infusion.

Each mL contains edetate disodium, anhydrous 150 mg. May contain sodium hydroxide for pH adjustment. pH is 7.0 (6.5 to 7.5). Edetate disodium is classified as a clinical chelating agent for emergency lowering of serum calcium in hypercalcemia. The solution contains no bacteriostat, antimicrobial agent or buffer (except for pH adjustment) and is intended only for use (after dilution) as a single-dose infusion. When smaller doses are required, the unused portion should be discarded.

Edetate Disodium, USP is chemically designated disodium (ethylenedinitrilo) tetraacetate dihydrate, a white crystalline powder soluble in water. It is also described as the disodium salt of ethylenediamine tetraacetic acid (EDTA) and has the following structural formula:

 ENDRATE (edetate disodium) Structural Formula Illustration

What are the possible side effects of edetate disodium (Disotate, Endrate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling like you might pass out; or
  • severe blistering, peeling, or red skin rash.

Less serious side effects include:

  • nausea, vomiting, diarrhea;
  • numbness or tingling (especially around your mouth);
  • headache; or
  • pain, redness, or swelling where the needle is...

Read All Potential Side Effects and See Pictures of Endrate »

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

Endrate (Edetate Disodium Injection, USP) is indicated in selected patients for the emergency treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity.

DOSAGE AND ADMINISTRATION

Edetate Disodium Injection, USP is administered by intravenous infusion only after dilution.

For Adults: The recommended daily dosage is 50 mg/kg of body weight to a maximum dose of 3 g in 24 hours. The dose, calculated by body weight, should be diluted in 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. The intravenous infusion should be regulated so that three or more hours are required for completion and the cardiac reserve of the patient is not exceeded. A suggested regimen includes five consecutive daily doses followed by two days without medication, with repeated courses as necessary to a total of 15 doses.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Endrate (Edetate Disodium Injection, USP) is supplied in 20 mL (3 g) ampuls, List No. 6940.

Store at 25°C (77°F) with excursions permitted between 15° to 30°C (59° to 86°F).

Rev: May, 2004. Hospira, Inc., Lake Forest, IL 60045 USA.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

SIDE EFFECTS

Gastrointestinal symptoms such as nausea, vomiting and diarrhea are fairly common following administration of this drug. Transient symptoms such as circumoral paresthesia, numbness and headache and a transient drop in systolic and diastolic blood pressure may occur. Thrombophlebitis, febrile reactions, hyperuricemia, anemia, exfoliative dermatitis and other toxic skin and mucous membrane reactions have been reported.

Nephrotoxicity and damage to the reticuloendothelial system with hemorrhagic tendencies have been reported with excessive dosages.

Read the Endrate (edetate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Drug/Laboratory Test 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.

Additives may be incompatible with the reconstituted (diluted) solution required for intravenous infusion. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

See WARNING statement, page 1.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Definitive statements cannot be made due to insufficient data and conflicting information.

Pregnancy Category C

Animal reproduction studies have not been conducted with Edetate Disodium Injection. It is also not known whether Edetate Disodium Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Edetate Disodium Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

The safety of this product in nursing mothers has not been established.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Endrate (edetate) ® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

OVERDOSE

Because of the possibility that Edetate Disodium Injection, USP may produce a precipitous drop in the serum calcium level, a source of calcium replacement suitable for intravenous administration (such as calcium gluconate) should be instantly available at the bedside before edetate disodium is administered. Extreme caution is dictated in the use of intravenous calcium in the treatment of tetany, especially in digitalized patients because the action of the drug and the replacement of calcium ions may produce a reversal of the desired digitalis effect.

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.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

CLINICAL PHARMACOLOGY

Edetate Disodium Injection, USP forms chelates with the cations of calcium and many divalent and trivalent metals. Because of its affinity for calcium, edetate disodium will produce a lowering of the serum calcium level during intravenous infusion. Slow infusion over a protracted period may cause mobilization of extracirculatory calcium stores. Edetate disodiumexerts a negative inotropic effect upon the heart.

After intravenous administration, the chelate formed is excreted in the urine with 50% appearing in 1 hour and over 95% in 24 hours. Edetate disodium likewise forms chelates with other polyvalent metals and produces increases in urinary excretion of magnesium, zinc and other trace elements. It does not form a chelate with potassium but may reduce the serum level and increase urinary loss of potassium.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

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Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

ENDRATE
(edetate disodium) Anhydrous Injection, Solution

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION
Ampul

WARNING

The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

DRUG DESCRIPTION

Endrate (Edetate Disodium Injection, USP) is a sterile, nonpyrogenic, concentrated solution of edetate disodium in water for injection which as a result of a pH adjustment with sodium hydroxide contains varying amounts of disodium and trisodium salts. After dilution, it is administered by intravenous infusion.

Each mL contains edetate disodium, anhydrous 150 mg. May contain sodium hydroxide for pH adjustment. pH is 7.0 (6.5 to 7.5). Edetate disodium is classified as a clinical chelating agent for emergency lowering of serum calcium in hypercalcemia. The solution contains no bacteriostat, antimicrobial agent or buffer (except for pH adjustment) and is intended only for use (after dilution) as a single-dose infusion. When smaller doses are required, the unused portion should be discarded.

Edetate Disodium, USP is chemically designated disodium (ethylenedinitrilo) tetraacetate dihydrate, a white crystalline powder soluble in water. It is also described as the disodium salt of ethylenediamine tetraacetic acid (EDTA) and has the following structural formula:

 ENDRATE (edetate disodium) Structural Formula Illustration

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

ENDRATE
(edetate disodium) Anhydrous Injection, Solution

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION
Ampul

WARNING

The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

DRUG DESCRIPTION

Endrate (Edetate Disodium Injection, USP) is a sterile, nonpyrogenic, concentrated solution of edetate disodium in water for injection which as a result of a pH adjustment with sodium hydroxide contains varying amounts of disodium and trisodium salts. After dilution, it is administered by intravenous infusion.

Each mL contains edetate disodium, anhydrous 150 mg. May contain sodium hydroxide for pH adjustment. pH is 7.0 (6.5 to 7.5). Edetate disodium is classified as a clinical chelating agent for emergency lowering of serum calcium in hypercalcemia. The solution contains no bacteriostat, antimicrobial agent or buffer (except for pH adjustment) and is intended only for use (after dilution) as a single-dose infusion. When smaller doses are required, the unused portion should be discarded.

Edetate Disodium, USP is chemically designated disodium (ethylenedinitrilo) tetraacetate dihydrate, a white crystalline powder soluble in water. It is also described as the disodium salt of ethylenediamine tetraacetic acid (EDTA) and has the following structural formula:

 ENDRATE (edetate disodium) Structural Formula Illustration

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

ENDRATE
(edetate disodium) Anhydrous Injection, Solution

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION
Ampul

WARNING

The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

DRUG DESCRIPTION

Endrate (Edetate Disodium Injection, USP) is a sterile, nonpyrogenic, concentrated solution of edetate disodium in water for injection which as a result of a pH adjustment with sodium hydroxide contains varying amounts of disodium and trisodium salts. After dilution, it is administered by intravenous infusion.

Each mL contains edetate disodium, anhydrous 150 mg. May contain sodium hydroxide for pH adjustment. pH is 7.0 (6.5 to 7.5). Edetate disodium is classified as a clinical chelating agent for emergency lowering of serum calcium in hypercalcemia. The solution contains no bacteriostat, antimicrobial agent or buffer (except for pH adjustment) and is intended only for use (after dilution) as a single-dose infusion. When smaller doses are required, the unused portion should be discarded.

Edetate Disodium, USP is chemically designated disodium (ethylenedinitrilo) tetraacetate dihydrate, a white crystalline powder soluble in water. It is also described as the disodium salt of ethylenediamine tetraacetic acid (EDTA) and has the following structural formula:

 ENDRATE (edetate disodium) Structural Formula Illustration

Last reviewed on RxList: 5/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Endrate Patient Information Including Side Effects

Brand Names: Disotate, Endrate

Generic Name: edetate disodium (EDTA) (Pronunciation: E de tate dye SOE dee um)

What is edetate disodium (Endrate)?

Edetate disodium (EDTA) is a chelating (KEE-late-ing) agent. A chelating agent is capable of removing a heavy metal, such as lead or mercury, from the blood.

EDTA is used to lower blood levels of calcium when they have become dangerously high. EDTA is also used to control heart rhythm disturbances caused by a heart medication called digitalis (digoxin, Lanoxin).

EDTA may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of edetate disodium (Endrate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling like you might pass out; or
  • severe blistering, peeling, or red skin rash.

Less serious side effects include:

  • nausea, vomiting, diarrhea;
  • numbness or tingling (especially around your mouth);
  • headache; or
  • pain, redness, or swelling where the needle is placed.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Endrate (edetate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about edetate disodium (Endrate)?

EDTA is given in a hospital or emergency setting. The medicine must be given slowly through a needle placed in your vein. The infusion can take at least 3 hours to complete.

If possible before you receive this medication, tell your caregivers if you have heart disease, congestive heart failure, a heart rhythm disorder, diabetes, low potassium (hypokalemia), or a history of seizures, brain tumor, or head injury.

In an emergency situation, it may not be possible before you are treated with EDTA to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

After treatment with EDTA, you will be watched to make sure the medication has been effective and you no longer have any effects of high calcium levels.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Endrate Patient Information including How Should I Take

What should I discuss with my health care provider before receiving edetate disodium (Endrate)?

You should not receive this medication if you are unable to urinate, or if you have arteriosclerosis (hardening of the arteries).

If possible, before you receive EDTA, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease, congestive heart failure;
  • a heart rhythm disorder;
  • a history of seizures, brain tumor, or head injury;
  • diabetes;
  • low potassium levels (hypokalemia); or
  • if you take digitalis (digoxin, Lanoxin, Lanoxicaps).

If you have any of these conditions, you may not be able to receive EDTA, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. If possible, tell your doctor if you are pregnant before you receive EDTA.

It is not known whether EDTA passes into breast milk or if it could harm a nursing baby. If possible, tell your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with EDTA to tell your caregivers if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

How is edetate disodium given (Endrate)?

EDTA is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting. The medicine must be given slowly through an IV infusion, and can take at least 3 hours to complete.

EDTA is usually given for 5 days in a row, followed by 1 day off the medicine. This schedule is then repeated for as long as needed until blood calcium levels are lowered to a safe level.

After you receive EDTA, you will need to remain lying down for a short time. Reversing high blood levels of calcium can cause a drop in your blood pressure. This can make you feel very light-headed or slow your breathing. You will need to be watched closely for these and other effects after you receive the medication.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with EDTA.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Endrate Patient Information including If I Miss a Dose

What happens if I miss a dose (Endrate)?

Since EDTA is given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose (Endrate)?

Tell your caregivers right away if you think you have received too much of this medicine. Overdose symptoms may include feeling light-headed or fainting.

What should I avoid after receiving edetate disodium (Endrate)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect edetate disodium (Endrate)?

There may be other drugs that can interact with EDTA. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about EDTA.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.04. Revision date: 12/15/2010.

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