Edetate Calcium Disodium
Generic: EDETATE CALCIUM DISODIUM
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22
Indications & Usage
INDICATIONS AND USAGE 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.
Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
Warnings
WARNINGS See Boxed Warning.
Adverse Reactions
ADVERSE REACTIONS The following adverse effects have been associated with the use of edetate calcium disodium: Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia.
Cardiovascular: hypotension, cardiac rhythm irregularities.
Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.
Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.
Nervous System: tremors, headache, numbness, tingling.
Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.
Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.
Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.
Hematopoietic: transient bone marrow depression, anemia.
Metabolic: zinc deficiency, hypercalcemia.
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Cardiovascular: hypotension, cardiac rhythm irregularities.
Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.
Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.
Nervous System: tremors, headache, numbness, tingling.
Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.
Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.
Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.
Hematopoietic: transient bone marrow depression, anemia.
Metabolic: zinc deficiency, hypercalcemia.
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .