Edetate Disodium USP

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg)
Available from:
Centre for Advanced Medicine
INN (International Name):
Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg)
Dosage:
150 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg) Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Units in package:
Ampoule, glass, Type 1 (not marketed), 20 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Akzo Nobel Chemicals bv
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, Type 1 - 20 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, crimp seal - 100 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, screw cap - 100 mL - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-3648
Authorization date:
1984-04-18

New Zealand Datasheet

Name of Medicine

EDETATE DISODIUM INJECTION, USP

Presentation

Edetate Disodium

Injection, USP

is a sterile, non-pyrogenic, concentrated solution of edetate

disodium in water for injection, which, as a result of pH adjustment with sodium hydroxide, contains

varying amounts of disodium and trisodium salts. Each ml contains: Edetate Disodium anhydrous

150mg,

in Water

Injection

q.s.

adjusted

with

Sodium

Hydroxide

necessary

Hydrochloric Acid. Approximate pH is 7 (range

6.5 –

Uses

Actions

Edetate disodium is classified as a clinical chelating agent for emergency lowering of serum calcium

in hypercalcemia.

Edetate

disodium,

chemically

designated

disodium

(ethylene-dinitrilo)

tetra-acetate

dihydrate, a white crystalline powder soluble in water. It is also described as the disodium salt of

ethylenediamine-tetra-acetic acid (EDTA).

Edetate disodium injection 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 disodium exerts a negative inotropic effect

upon the heart.

Pharmacokinetics

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.

Indications

Edetate

Disodium

injection

indicated

selected

patients

emergency

treatment

hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity.

Dosage and Administration

Edetate Disodium injection is administered by intravenous infusion only after dilution. 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.

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.

For Children: The recommended daily dosage is 40 mg/kg (1 g per 25 kg) of body weight. The dose,

calculated by body weight should be diluted in a sufficient volume of 5% Dextrose Injection, or 0.9º/o

Sodium Chloride Injection, USP to bring the final concentration of edetate disodium to not more than

3%. 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. The maximum dose is 70 mg/kg

per 24 hour period.

Parental drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit, see Warnings and Precautions.

Contraindications

Edetate Disodium Injection is contraindicated in anuric patients. It is also contraindicated in those

persons who have shown hypersensitivity to any component of this preparation.

Warnings and Precautions

FOR INTRAVENOUS INFUSION ONLY AFTER DILUTION

The use of this medicine in any particular patient is recommended only when the severity of the

clinical condition justifies the aggressive measures associated with this type of therapy.

Rapid intravenous infusion or attainment of high serum concentration of edetate disodium may cause

a precipitous drop in the serum calcium level and may 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, Edetate Disodium injection should be diluted before infusion, see

Dosage and Administration.

After the infusion of Edetate Disodium injection, the patient should remain in bed for a short time

because of the possibility of postural hypotension.

possibility

adverse

effect

myocardial

contractility

should

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 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.

Use in Pregnancy

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 foetal 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.

Use in Lactation

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

Effects on Ability to Drive and Use Machines

No effect expected.

Adverse Effects

Gastrointestinal symptoms such as nausea, vomiting and diarrhoea 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, anaemia, exfoliative dermatitis and other toxic skin and mucous

membrane reactions have been reported.

Nephrotoxicity and damage to the reticuloendothelial system with haemorrhagic tendencies have

been reported with excessive dosages.

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.

Overdosage

Because of the possibility that edetate disodium injection 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.

Pharmaceutical Precautions

Store at controlled room temperature 15ºC – 30ºC. Avoid Excessive heat. Protect from freezing.

Medical Classification

Prescription Medicine.

Package Quantities

Edetate Disodium

Injection, USP

, 150 mg/ml is available in 100 ml vials or 20 ml ampoules.

Further Information

Incompatabilities

Drug Interactions: 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.

Name and Address

Centre for Advanced Medicine Ltd

110 Remuera Rd,

Auckland

New Zealand

Ph (09) 524-7743

Fax (09) 524-7745

Date of Preparation

3 June 2000

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