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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.
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VERSENATE SUMMARY
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.
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.
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NEWS HIGHLIGHTS
Published Studies Related to Versenate (Edetate Calcium Disodium)
A randomised double-blind study comparing sodium feredetate with ferrous fumarate in anaemia in pregnancy. [2007.05]
Iron deficiency anaemia is a major health problem in India especially in women of reproductive age group. The World Health Organisation recommends that the haemoglobin concentration should not fall below 11.0 g/dl at any time during pregnancy... As there were no adverse effects reported with sodium feredetate, it can be concluded from this study that this new formulation appears to be effective in improving haemoglobin profile in pregnant anaemic women and is tolerated well.
Microbial growth in propofol formulations with disodium edetate and the influence of venous access system dead space. [2007.06]
Propofol formulated in lipid supports microbial growth. We hypothesised that propofol with disodium edetate would suppress microbial growth more than propofol without disodium edetate... However, for prevention of healthcare-associated infections, medical professionals should maintain strict aseptic precautions when handling propofol, use disodium edetate-containing formulations, and should consider using venous access systems without dead space.
Deaths resulting from hypocalcemia after administration of edetate disodium: 2003-2005. [2006.08]
From 2003 to 2005, deaths of 3 individuals as a result of cardiac arrest caused by hypocalcemia during chelation therapy were reported to the Centers for Disease Control and Prevention. Two were children, both of whom were treated with edetate disodium.From our experience and review of the literature, we suggest that health care providers who are unfamiliar with chelation consult an expert before undertaking treatment and that hospital formularies evaluate whether stocking edetate disodium is necessary, given the risk for hypocalcemia and the availability of less toxic alternatives.
[Visual evoked potentials in children cured with sodium-calcium versenate because of high blood lead level--the prospective study] [2005]
CONCLUSIONS: Delayed P100 latency of PVEP in children is permanent but non-progressive if Pb-B is lower than 100 microg/l.
Clinical Trials Related to Versenate (Edetate Calcium Disodium)
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency [Completed]
Previous study showed repeated lead chelation therapy significant reduced progressive renal
insufficiency in patients with chronic renal diseases and high-normal body lead burden in a
placebo-controlled, randomized, 2-year clinical trial, even factors that influence
progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary
protein excretion were well controlled. Since relative small sample size and short duration of
follow-up were noted in the previous study, whether repeated lead chelation therapy could
long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted
a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated
chelation in progressive renal insufficiency of patients with high-normal body lead burden.
Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis [Not yet recruiting]
One thousand patients with LHD who have no history of exposure to lead will be observed for
18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high
sensitivity C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The
morbidity and mortality are recorded in detail. Then, one hundred subjects with high BLL
(>20μg/dl) will be randomly assigned to the study and control groups. For 3-6 months, the 50
patients in the study group will receive lead-chelation therapy with calcium disodium EDTA
weekly until the BLB falls below BLL< 5 μg/dl, and the 50 control group patients receive
weekly placebo for 12 weeks. During the ensuing 18 months, the BLL, biochemical data will be
regularly followed up every 3 months. BLL is measured every 6 months. If BLL of the study
group patients increase >10 μg/dl, the chelation therapy will be performed again until their
BLL is <5 μg/dl. The primary end point is morbidity or mortality during the observation and
follow-up period. A secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP
during the follow up period.
Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection [Completed]
RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in
patients at high risk for a catheter-related infection. It is not yet known whether heparin
is more effective than M-EDTA in preventing catheter-related infections and blockages in
patients at high risk for a catheter-related infection.
PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared
with M-EDTA in preventing catheter-related infections and blockages in patients at high risk
for a catheter-related infection.
Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy [Recruiting]
Background The relationship between long-term heavy lead exposure and chronic interstitial
nephropathy is well recognized in the previous literatures. Several epidemiological studies
have demonstrated a positive association between blood lead levels and the age related
decreases of renal function in the general population and suggested that environmental
low-level lead exposure may accelerate the progression of renal function in the healthy
persons. In addition, previous our works suggest environmental lead exposure may correlate to
progressive renal insufficiency and lead chelation therapy or repeated lead chelation may
improve and slow the progressive renal insufficiency in non-diabetic patients with chronic
renal diseases. However, Diabetes mellitus is increasing in prevalence worldwide and is
currently estimated to affect more than 6. 5 percent of the population of the United States.
In addition, diabetes is the most common cause of end-stage renal disease in many countries,
accounting for about 40 percent of cases. It is still unknown that the relationship between
long-term environmental lead exposure and the progressive renal insufficiency in patients
with type II diabetes and diabetic nephropathy.
Methods One hundred and two patients with type II diabetes and diabetic nephropathy (serum
creatinine levels between 1. 5 mg per deciliter and 3. 9 mg per deciliter) who have a normal
body lead burden and no history of exposure to lead or other metals will be observed for 24
months. Then, about 60 subjects with high normal body lead burdens (at least 80 μg but less
than 600 μg) will be randomly assigned to the study and control groups. For three months, the
30 patients in the study group willvreceive lead-chelation therapy with calcium disodium EDTA
weekly until the body lead burden fallsl below 60 μg, and the 30 control group receive weekly
placebo. During the ensuing 24 months, the renal function will be regularly followed up every
3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of
the study group patients increase more than 60μg, the chelation therapy will be performed
again until their body burden are less than 60 μg. The primary end point is an increase in
the serum creatinine level to 1. 5 times the base-line value during the observation period. A
secondary end point is the change in renal function during the follow up period.
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Page last updated: 2007-10-18
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