in order to [70:20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m 2 /day whether given intravenously or intramuscularly. (See Surface Area Nomogram .) For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m 2 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, 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 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 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. Calcium Disodium Versenate 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 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. Intravenous Administration Add the total daily dose of Calcium Disodium Versenate (1000 mg/m 2 /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 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. Intramuscular Administration The total daily dosage (1000 mg/m 2 /day) should be divided into equal doses spaced 8 12 hours apart. Lidocaine or procaine should be added to the Calcium Disodium Versenate 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 Calcium Disodium Versenate; 1 ml of 1% lidocaine or procaine solution per ml of concentrated Calcium Disodium Versenate. When used alone, regardless of method of administration, Calcium Disodium Versenate should not be given at doses larger than those recommended. Diagnostic Test 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. How is Calcium Disodium Versenate Supplied Calcium Disodium Versenate injection, 5 mL ampul containing 200 mg of edetate 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) [see USP Controlled Room Temperature]. Rx Only This product is non-returnable. REFERENCES 1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylenediamine tetraacetate treatment of lead-poisoned children. J Pharmacol Exp Therapeu 1986; 239: 829 835. 2. The Pharmacological Basis of Therapeutics, 7th edition, Goodman and Gilman, editors. MacMillan Publishing Company, New York, 1985, pp. 1619 1622. 3. Hammond PB, Aronson AL, Olson WC. The mechanism of mobilization of lead by ethylenediaminetetraacetate. J Pharmacol Exp Therapeu 1967; 157: 196 206. 4. Van deVyver FL, D'Haese PC, Visser WJ, et al. Bone lead in dialysis patients. Kidney Intl 1988; 33: 601 607. 5. Cory-Slecta DA, Weiss B, Cox C. Mobilization and redistribution of lead over the course of calcium disodium ethylenediamine tetraacetate chelation therapy. J Pharmacol Exp Therapeu 1987; 243: 804 813. 6. Chisolm JJ. Mobilization of lead by calcium disodium edetate. Am J Dis Child 1987; 141: 1256 1257. 7. Drug Evaluations, 6th Edition, American Medical Association, Saunders, Philadelphia, 1986, pp. 1637 1639. 8. Centers for Disease Control: Preventing lead poisoning in young children. Atlanta, GA, Department of Health and Human Services, 1985 Jan. 9. Finberg L, Rajagopal V. Diagnosis and treatment of lead poisoning in children. J Family Med 1985 April: 3 12. 10. Schardein JL, Sakowski R, Petrere J, et al. Teratogenesis studies with EDTA and its salts in rats. Toxicol Appl Pharmacol 1981; 61: 423 428. 11. Swenerton H, Hurley LS. Teratogenic effects of a chelating agent and their prevention by zinc. Science 1971; 173: 62 64. 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 CaNa 2 EDTA (Calcium Disodium Versenate) 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: Medicis, The Dermatology Company Scottsdale, AZ 85256 By: CP Pharmaceuticals, Ltd . Wrexham LL13 9UF, U.K. Product of UK 106055/1 Rev. 10/12 PRINCIPAL DISPLAY PANEL - 5 mL Ampule Carton NDC 99207-240-05 5 ampuls per carton Calcium Disodium Versenate (edetate calcium disodium injection, USP) 1000 mg/5 mL (200 mg/mL) For intravenous or intramuscular administration only MEDICIS Calcium Disodium Versenate edetate calcium disodium injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-240 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EDETATE CALCIUM DISODIUM (EDETIC ACID) EDETATE CALCIUM DISODIUM 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER Packaging # Item Code Package Description 1 NDC:99207-240-05 5 AMPULE in 1 CARTON 1 5 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA008922 06/21/2013 Labeler - Medicis Pharmaceutical Corp (182837492) Establishment Name Address ID/FEI Operations CP Pharmaceuticals Ltd 226503308 MANUFACTURE(99207-240) Revised: 07/2013 Medicis Pharmaceutical Corp Next Interactions Print this page Add to My Med List More about Calcium Disodium Versenate (edetate calcium disodium) Side Effects During Pregnancy Dosage Information Drug Interactions Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antidotes Consumer resources Calcium Disodium Versenate Professional resources Calcium Disodium Versenate (AHFS Monograph) Related treatment guides Lead Poisoning, Mild Lead Poisoning, Severe]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Valeant Pharmaceuticals International, Inc. Drug Class Antidotes Related Drugs antidotes naltrexone , atropine , naloxone , acetylcysteine , leucovorin Lead Poisoning, Mild n/a Lead Poisoning, Severe Chemet , succimer , More... Calcium Disodium Versenate Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } keep at bay
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