EDETATE CALCIUM DISODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) (EDETIC ACID - UNII:9G34HU7RV0)

Available from:

Casper Pharma LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead. Edetate calcium disodium injection should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.

Product summary:

Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 70199-034-05 ) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 70199-034-55 ). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only This product is non-returnable.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EDETATE CALCIUM DISODIUM - EDETATE CALCIUM DISODIUM INJECTION
CASPER PHARMA LLC
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EDETATE CALCIUM DISODIUM INJECTION, USP
INTRAVENOUS OR INTRAMUSCULAR USE
RX ONLY
WARNINGS
Edetate calcium disodium injection is capable of producing toxic
effects which can
be fatal. Lead encephalopathy is relatively rare in adults, but occurs
more often in
pediatric patients in whom it may be incipient and thus overlooked.
The mortality
rate in pediatric patients has been high. Patients with lead
encephalopathy and
cerebral edema may experience a lethal increase in intracranial
pressure following
intravenous infusion; the intramuscular route is preferred for these
patients. In
cases where the intravenous route is necessary, avoid rapid infusion.
The dosage
schedule should be followed and at no time should the recommended
daily dose be
exceeded.
DESCRIPTION
Edetate Calcium Disodium injection, USP is a sterile, injectable,
chelating agent in
concentrated solution for intravenous infusion or intramuscular
injection. Each 5 mL
single-dose vial contains 1000 mg of edetate calcium disodium
(equivalent to 200
mg/mL) in water for injection and sodium hydroxide (as pH adjuster).
Chemically, this
product is called
[[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)-glycinato]](4-)-
N,N',O,O',O ,O ]-, disodium, hydrate, (OC-6-21)-Calciate(2-).
STRUCTURAL FORMULA:
N
N'
C
H
CaN Na O • × H O
Molecular weight 374.27 (anhydrous)
CLINICAL PHARMACOLOGY
The pharmacologic effects of edetate calcium disodium are due to the
formation of
chelates with divalent and trivalent metals. A stable chelate will
form with any metal that
has the ability to displace calcium from the molecule, a feature
shared by lead, zinc,
cadmium, manganese, iron and mercury. The amounts of manganese and
iron mobilized
are not significant. Copper
is not mobilized and mercury is unavailable for chelation
because it is too tightly bound to body ligands or it is stored in
inaccessible body
compartments. The excretion of calcium by the body is not increased
following
intravenous