Calcium Disodium Versenate
"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Calcium Disodium Versenate
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.
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 Calcium Disodium Versenate for asymptomatic adults and pediatric patients whose blood lead level is < 70 mcg/dl but > 20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m2/day whether given intravenously or intramuscularly. (See Surface Area Nomogram.)
SURFACE AREA NOMOGRAM
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
Calcium Disodium Versenate (edetate calcium disodium injection) , 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 Calcium Disodium Versenate (edetate calcium disodium injection) 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 Calcium Disodium Versenate (edetate calcium disodium injection) 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 tolerance of the drug.
Calcium Disodium Versenate (edetate calcium disodium injection) 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 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 Calcium Disodium Versenate (edetate calcium disodium injection) should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease.
Add the total daily dose of Calcium Disodium Versenate (edetate calcium disodium injection) (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. Calcium Disodium Versenate (edetate calcium disodium injection) injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride.
The total daily dosage (1000 mg/m2/day) should be divided into equal doses spaced 8-12 hours apart. Lidocaine or procaine should be added to the Calcium Disodium Versenate (edetate calcium disodium injection) 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 (entire content of ampul) concentrated Calcium Disodium Versenate (edetate calcium disodium injection) ; 1 ml of 1% lidocaine or procaine solution per ml of concentrated Calcium Disodium Versenate (edetate calcium disodium injection) . When used alone, regardless of method of administration, Calcium Disodium Versenate (edetate calcium disodium injection) should not be given at doses larger than those recommended.
Several methods have been described for lead mobilization tests using edetate 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 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.
Calcium Disodium Versenate (edetate calcium disodium injection) injection, 5 ml ampul containing 200 mg of edetate calcium disodium per ml (1 g per ampul), in boxes containing 6 ampuls (NDC 0089-0510-06).
Store at controlled room temperature 15°-30°C (59°-86°F).
7. Drug Evaluations, 6th Edition, American Medical Association, Saunders, Philadelphia, 1986, pp. 1637-1639.
9. Finberg L, Rajagopal V. Diagnosis and treatment of lead poisoning in children. J Family Med 1985 April: 3-12.
12. American Hospital Formulary Service, Drug Information, 1988, pp. 1695-1698.
13. Markowitz ME, Rosen JF. Assessment of lead stores in children: Validation of an 8-hour CaNa2EDTA (Calcium Disodium Versenate (edetate calcium disodium injection) ) provocative test. J Pediatrics 1984; 104:337-341.
14. Piomelli S, Rosen JF, Chisolm JJ, et al. Management of childhood lead poisoning. J Pediatrics 1984; 105:523-532.
15. Sachs HK, Blanksma LA, Murray EF, et al. Ambulatory treatment of lead poisoning: Report of 1,155 cases. Pediatrics 1970; 46:389.
16. Chisolm JJ. The use of chelating agents in the treatment of acute and chronic lead intoxication in childhood. J Pediatrics 1968; 73:1.
17. Coffin R, Phillips JL, Staples WI, et al. Treatment of lead encephalopathy in children. J Pediatrics 1966; 69:198-206.
18. Chisolm JJ. Increased lead absorption and acute lead poisoning. Current Pediatric Therapy 12, Gillis and Kagan, editors, WB Saunders, Philadelphia, 1986, pp. 667-671.
Manufactured for: 3M Pharmaceuticals, Northridge, CA 91324. By Hospira, Inc. Lake Forest, IL 60045. July 2004. FDA Rev date: 4/12/2002
Last reviewed on RxList: 11/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Calcium Disodium Versenate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.