DRUGS & SUPPLEMENTS
Active ingredient: Edetate Disodium
Edetate Disodium uses
INDICATIONS AND USAGE
Edetate Disodium 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 Disodium calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.
Edetate Disodium calcium disodium may produce the same renal damage as lead poisoning, such as proteinuria and microscopic hematuria. Treatment-induced nephrotoxicity is dose-dependent and may be reduced by assuring adequate diuresis before therapy begins. Urine flow must be monitored throughout therapy which must be stopped if anuria or severe oliguria develop. The proximal tubule hydropic degeneration usually recovers upon cessation of therapy. Edetate Disodium calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Patients should be monitored for cardiac rhythm irregularities and other ECG changes during intravenous therapy.
Information for patients
Patients should be instructed to immediately inform their physician if urine output stops for a period of 12 hours.
Urinalysis and urine sediment, renal and hepatic function and serum electrolyte levels should be checked before each course of therapy and then be monitored daily during therapy in severe cases, and in less serious cases after the second and fifth day of therapy. Therapy must be discontinued at the first sign of renal toxicity. The presence of large renal epithelial cells or increasing number of red blood cells in urinary sediment or greater proteinuria call for immediate stopping of Edetate Disodium calcium disodium administration. Alkaline phosphatase values are frequently depressed, but return to normal within 48 hours after cessation of therapy. Elevated erythrocyte protoporphyrin levels (> 35 mcg/dl of whole blood) indicate the need to perform a venous blood lead determination. If the whole blood lead concentration is between 25–55 mcg/dl a mobilization test can be considered.7,8 (See Diagnostic Test .) An elevation of urinary coproporphyrin (adults: > 250 mcg/day; pediatric patients under 80 lbs: > 75 mcg/day) and elevation of urinary delta aminolevulinic acid (ALA) (adults: > 4 mg/day; pediatric patients: > 3 mg/m2/day) are associated with blood lead levels > 40 mcg/dl. Urinary coproporphyrin may be falsely negative in terminal patients and in severely iron-depleted pediatric patients who are not regenerating heme.9 In growing pediatric patients long bone x-rays showing lead lines and abdominal x-rays showing radio-opaque material in the abdomen may be of help in estimating the level of exposure to lead.
There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of Edetate Disodium calcium disodium in animals.7 Edetate Disodium calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc.7
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term animal studies have not been conducted with Edetate Disodium calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility.
One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Edetate Disodium.10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to Edetate Disodium, which were prevented by simultaneous supplementation of dietary zinc.11 There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
Edetate Disodium has no recognized use during labor and delivery, and its effects during these processes are unknown.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Edetate Disodium is administered to a nursing woman.
Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, Edetate Disodium is used in patients of all ages. The intramuscular route is preferred by some for young pediatric patients. In cases where the intravenous route is necessary, avoid rapid infusion. (See WARNINGS.) Urine flow must be monitored throughout therapy; Edetate Disodium therapy must be stopped if anuria or severe oliguria develops. (See General Precautions .) At no time should the recommended daily dosage be exceeded. (See DOSAGE AND ADMINISTRATION .)
The following adverse effects have been associated with the use of Edetate Disodium 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.
Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dl did not cause any ill effects. Edetate Disodium calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects appear to be associated with lead poisoning. Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of Edetate Disodium calcium disodium may produce a more severe zinc deficiency.
Cerebral edema should be treated with repeated doses of mannitol. Steroids enhance the renal toxicity of Edetate Disodium calcium disodium in animals and, therefore, are no longer recommended.7 Zinc levels must be monitored. Good urinary output must be maintained because diuresis will enhance drug elimination. It is not known if Edetate Disodium calcium disodium is dialyzable.
DOSAGE AND ADMINISTRATION
When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of Edetate Disodium for asymptomatic adults and pediatric patients whose blood lead level is < 70 mcg/dl but > 20 mcg/dl is 1000 mg/m2/day whether given intravenously or intramuscularly.
For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 every 24 hours for 5 days for patients with serum creatinine levels of 2–3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3–4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl. These regimens may be repeated at one month intervals.12
Edetate Disodium, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that Edetate Disodium be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy.14–18
Therapy of lead poisoning in adults and pediatric patients with Edetate Disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug.
Edetate Disodium is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients.
Acutely ill individuals may be dehydrated from vomiting. Since Edetate Disodium calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy. Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of Edetate Disodium should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate Disodium calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease.
Add the total daily dose of Edetate Disodium (1000 mg/m2/day) to 250–500 ml of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8–12 hours. Edetate Disodium injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride.
The total daily dosage should be divided into equal doses spaced 8–12 hours apart. Lidocaine or procaine should be added to the Edetate Disodium injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/ml (0.5%) can be obtained as follows: 0.25 ml of 10% lidocaine solution per 5 ml concentrated Edetate Disodium; 1 ml of 1% lidocaine or procaine solution per ml of concentrated Edetate Disodium. When used alone, regardless of method of administration, Edetate Disodium should not be given at doses larger than those recommended.
Several methods have been described for lead mobilization tests using Edetate Disodium calcium disodium to assess body stores.7, 9,12,13,18
These procedures have advantages and disadvantages that should be reviewed in current references. Edetate Disodium calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated.
Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Edetate Disodium injection, 5 mL ampul containing 200 mg of Edetate Disodium 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).
This product is non-returnable.
Medicis, The Dermatology Company
Scottsdale, AZ 85256
By: CP Pharmaceuticals, Ltd.
Wrexham LL13 9UF, U.K.
Product of UK
Edetate Disodium available forms, composition, doses:
Indications and Usages:
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Frequently asked QuestionsCan i drive or operate heavy machine after consuming Edetate Disodium?
Depending on the reaction of the Edetate Disodium after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Edetate Disodium not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Edetate Disodium addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Edetate Disodium, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Edetate Disodium consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
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One visitor reported frequency of useHow often in a day do you take the medicine?
Are you taking the Edetate Disodium drug as prescribed by the doctor?
Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Edetate Disodium is mentioned below.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology