País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) (EDETIC ACID - UNII:9G34HU7RV0)
Casper Pharma LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
EDETATE CALCIUM DISODIUM - EDETATE CALCIUM DISODIUM INJECTION CASPER PHARMA LLC ---------- 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 Llegiu el document complet