CALCIUM DISODIUM VERSENATE- 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:

Bausch Health Us, LLC

INN (International Name):

EDETATE CALCIUM DISODIUM

Composition:

EDETATE CALCIUM DISODIUM 200 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Edetate calcium disodium 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 should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.

Product summary:

Calcium Disodium Versenate injection, 5 mL ampul containing 200 mg of edetate calcium disodium per ml (1000 mg per ampul), in boxes containing 5 ampuls (NDC 99207-240-05 ). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

CALCIUM DISODIUM VERSENATE- EDETATE CALCIUM DISODIUM INJECTION
BAUSCH HEALTH US, LLC
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CALCIUM DISODIUM VERSENATE
(EDETATE CALCIUM DISODIUM INJECTION, USP)
INTRAVENOUS OR INTRAMUSCULAR USE
RX ONLY
WARNINGS
Calcium Disodium Versenate 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
Calcium Disodium Versenate (edetate calcium disodium injection, USP)
is a sterile, injectable, chelating
agent in concentrated solution for intravenous infusion or
intramuscular injection. Each 5 ml ampul
contains 1000 mg of edetate calcium disodium (equivalent to 200 mg/ml)
in water for injection.
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:
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 intravenou