Today's med: Edetate CALCIUM Disodium (EDTA) (ED e tate KAL see um dye SOW dee um)
(brand name:Calcium Disodium Versenate®)
Drug Class: Chelating Agent
Action: Calcium is displaced by divalent and trivalent heavy metals, forming a nonionizing soluble complex that is excreted in urine
Indications:
Contraindications: Active renal disease or anuria; hepatitis
Adverse Effects:
Central nervous system: Chills, fatigue, fever, headache, malaise
Dermatologic: Cheilosis, dermatitis, rash
Endocrine & metabolic: Hypercalcemia, hypokalemia
Gastrointestinal: Anorexia, GI upset, nausea, thirst (excessive), vomiting
Hematologic: Anemia, bone marrow suppression (transient)
Hepatic: Alkaline phosphatase decreased, liver function test increased (mild)
Local: Pain at injection site (I.M. injection), thrombophlebitis (I.V. infusion when concentration >5 mg/mL)
Neuromuscular & skeletal: Arthralgia, myalgia, numbness, paresthesia, tremor
Ocular: Lacrimation
Renal: Glucosuria, microscopic hematuria, nephrosis, nephrotoxicity, proteinuria, renal tubular necrosis, urinary frequency/urgency
Respiratory: Nasal congestion, sneezing
Miscellaneous: Iron, magnesium, and/or zinc deficiency (with chronic therapy)
Warnings/Precautions
Concerns related to adverse effects:
• Arrhythmias: Monitor for arrhythmias and ECG changes during I.V. therapy
• Nephrotoxicity: Edetate CALCIUM disodium is potentially nephrotoxic. Renal tubular acidosis and fatal nephrosis may occur, especially with high doses; do not exceed the recommended daily dose. If anuria, increasing proteinuria, or hematuria occurs during therapy, discontinue use. Minimize nephrotoxicity by providing adequate hydration, establishment of good urine output, avoidance of excessive doses, and limit continuous administration to ≤5 days.
Disease-related concerns:
• Cerebral edema: [U.S. Boxed Warning]: Use with extreme caution in patients with lead encephalopathy and cerebral edema. In these patients, I.V. infusion has been associated with lethal increase in intracranial pressure; I.M. injection is preferred.
• Lead poisoning: Investigate, identify, and remove sources of lead exposure prior to treatment. Primary care providers should consult experts in chemotherapy of lead toxicity before using chelation drug therapy. Do not permit patients to re-enter the contaminated environment until lead abatement has been completed.
• Renal impairment: Use with caution in patients with renal impairment; reduced dose recommended.
Other warnings/precautions:
• Potential for name confusion: Exercise caution in the ordering, dispensing, and administration of this drug. Edetate CALCIUM disodium (CaEDTA) may be confused with edetate disodium (Na2EDTA) (not commercially available in the U.S. or Canada). Fatal hypocalcemia may result if edetate disodium is used for the treatment of lead poisoning instead of edetate CALCIUM disodium (Baxter, 2008). The CDC and FDA recommend that edetate disodium should never be used for chelation therapy (especially in children) (Mitka, 2008). Death has occurred following the use of edetate disodium for chelation therapy in pediatric patients with autism (Baxter, 2008).
Urinary output; urinalysis; renal function, hepatic function, serum electrolytes (baseline and daily [severe lead poisoning] or at days 2 and 5 [less severe lead poisoning]); ECG (with I.V. therapy); blood lead levels (baseline and 7-21 days after completing chelation therapy); hemoglobin or hematocrit; iron status; free erythrocyte protoporphyrin or zinc protoporphyrin; neurodevelopmental changes
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Lab Test Interferences
If edetate CALCIUM disodium is given as a continuous I.V. infusion, stop the infusion for at least 1 hour before blood is drawn for lead concentration to avoid a falsely elevated value
Standard Dosing:
Lead poisoning: Note: For the treatment of high blood lead levels in children, the CDC recommends chelation treatment when blood lead levels are >45 mcg/dL (CDC, 2002). The AAP recommends succimer as the drug used for initial management in asymptomatic children when blood lead levels are >45 mcg/dL and <70 mcg/dL. Edetate CALCIUM disodium can be used in children allergic to succimer (AAP, 2005; Chandran, 2010). Combination therapy with edetate CALCIUM disodium and dimercaprol is recommended for use in children whose blood lead levels are ≥70 mcg/dL or in children with lead encephalopathy (AAP, 2005; Chandran, 2010). In adults, available guidelines recommend chelation therapy with blood lead levels >50 mcg/dL and significant symptoms; chelation therapy may also be indicated with blood lead levels ≥100 mcg/dL and/or symptoms (Kosnett, 2007). Depending upon the blood lead level, additional courses may be necessary; at least 2-4 days should elapse before repeat treatment is initiated.
Blood lead levels <70 mcg/dL and asymptomatic:
Children: 1000 mg/m2/day for 5 days or 50 mg/kg/day (maximum: 1000 mg/day) for 5 days (Chandran, 2010)
Adults: 1000 mg/m2/day for 5 days
Blood lead levels ≥70 mcg/dL or symptomatic lead poisoning (in conjunction with dimercaprol): Note: Begin treatment with edetate CALCIUM disodium with the second dimercaprol dose:
Children: 1000 mg/m2/day or 25-50 mg/kg/day (maximum: 1000 mg/day) for 5 days (Chandran, 2010; Howland, 2011)
Adults: 1000 mg/m2/day or 25-50 mg/kg/day for 5 days; a maximum dose of 3000 mg has been suggested (Howland, 2011)
Lead encephalopathy (in conjunction with dimercaprol): Note: Begin treatment with edetate CALCIUM disodium with the second dimercaprol dose:
Children: 1500 mg/m2/day or 50-75 mg/kg/day (maximum: 1000 mg/day) for 5 days (Chandran, 2010; Howland, 2011)
Adults: 1500 mg/m2/day or 50-75 mg/kg/day for 5 days; a maximum dose of 3000 mg has been suggested (Howland, 2011)
Lead nephropathy: Adults: An alternative dosing regimen reflecting the reduction in renal clearance is based upon the serum creatinine; Note: Repeat regimen monthly until lead levels are reduced to an acceptable level:
Scr 2-3 mg/dL: 500 mg/m2 every 24 hours for 5 days
Scr 3-4 mg/dL: 500 mg/m2 every 48 hours for 3 doses
Scr >4 mg/dL: 500 mg/m2 once weekly
For I.M. or I.V. use; I.V. is generally preferred, however, the I.M. route is preferred when cerebral edema is present.
I.V. infusion: Administer the daily dose as a diluted solution over 8-12 hours or continuously over 24 hours (Howland, 2011)
For I.M. injection: Daily dose should be divided into 2-3 equal doses spaced 8-12 hours apart. Procaine hydrochloride or lidocaine may be added to the edetate CALCIUM disodium to minimize pain at injection site. Administer by deep I.M. injection. When used in conjunction with dimercaprol, inject into a separate site.
Drug
interactions:
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for agranulocytosis may be increased. Avoid combination
Insulin: Edetate CALCIUM Disodium may enhance the hypoglycemic effect of Insulin. Monitor therapy
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