CALCIUM DISODIUM VERSENATE
Clinical safety rating
cautionComprehensive clinical and safety monograph for CALCIUM DISODIUM VERSENATE (CALCIUM DISODIUM VERSENATE).
Calcium disodium edetate chelates heavy metals (e.g., lead, cadmium) forming stable, water-soluble complexes that are excreted renally, reducing metal burden and toxicity.
| Metabolism | Not metabolized; excreted unchanged in urine via glomerular filtration and tubular secretion. |
| Excretion | Renal: >95% as chelated lead complex; biliary/fecal: negligible (<5%) |
| Half-life | Terminal elimination half-life: 20-30 minutes for unchelated drug; lead-chelate complex half-life: 1-2 hours. Clinical context: Short half-life necessitates continuous or repeated dosing for sustained chelation. |
| Protein binding | <5% bound to plasma proteins (albumin) |
| Volume of Distribution | 0.2-0.3 L/kg; primarily distributes to extracellular fluid, minimal intracellular penetration |
| Bioavailability | IV: 100%; IM: approximately 80-90% (due to local chelation and partial excretion) |
| Onset of Action | IV: Immediate (minutes) for chelation; IM: 30-60 minutes |
| Duration of Action | Chelation effect persists for 6-12 hours after dose; urinary lead excretion peaks at 2-6 hours post-dose |
| Molecular Weight | 374.28 |
1-2 g intramuscularly or intravenously every 12 hours for 3-5 days, followed by 2-5 days off, repeating as needed.
| Dosage form | INJECTABLE |
| Renal impairment | GFR > 50 mL/min: no adjustment; GFR 10-50 mL/min: administer 50% of usual dose; GFR < 10 mL/min: administer 25% of usual dose or consider alternative therapy. |
| Liver impairment | No specific guidelines available; use with caution and monitor liver function in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | 25 mg/kg/dose intramuscularly or intravenously every 12 hours for 3-5 days; maximum 1 g/dose. |
| Geriatric use | Consider renal function; elderly patients often require dose reduction based on creatinine clearance; start at lower end of dosing range and monitor for adverse effects. |
| 1st trimester | Limited human data; animal studies not available. Use only if clearly needed and benefit outweighs risk. |
| 2nd trimester | Limited human data; caution advised. May be used for severe lead poisoning. |
| 3rd trimester | Limited human data; caution advised. May be used for severe lead poisoning. |
Clinical note
Comprehensive clinical and safety monograph for CALCIUM DISODIUM VERSENATE (CALCIUM DISODIUM VERSENATE).
| Placental transfer | Crosses placenta in animal studies; human data limited but likely similar. |
| Breastfeeding | Excretion into breast milk unknown; potential for adverse effects in infant. Avoid if possible; if used, monitor infant for symptoms. |
| Lactation Rating | L4 (Possibly Hazardous) |
| Teratogenic Risk | Limited human data. Animal studies show fetal toxicity at high doses. First trimester: theoretical risk of chelation of essential minerals. Second and third trimesters: risk of fetal zinc/corper deficiency if prolonged use. Avoid unless maternal benefit outweighs risk. |
| Fetal Monitoring | Monitor serum calcium, magnesium, zinc, and copper levels; renal function; urine output; fetal growth via ultrasound if prolonged therapy. |
| Fertility Effects | No known direct effects on fertility in humans. Animal studies show no significant reproductive impairment. |
■ FDA Black Box Warning
This drug is not indicated for the treatment of iron deficiency anemia or hemochromatosis. Do not use in patients with severe renal impairment. Prolonged or excessive use may lead to toxicities including renal failure, convulsions, and cardiac arrhythmias.
| Serious Effects |
AnuriaSevere renal diseaseKnown hypersensitivity to edetate calcium disodium
| Precautions | Renal toxicity: monitor renal function and urine output; avoid excessive doses. Neurotoxicity: can cause tremors, seizures, and encephalopathy, especially with high doses or rapid infusion. Hydration: maintain adequate hydration to promote urinary excretion. Rebound metal mobilization: may transiently increase tissue metal levels. Hypocalcemia: due to calcium displacement; monitor serum calcium. Cardiac effects: risk of arrhythmias, especially with rapid IV administration. |
| Food/Dietary | Avoid excessive intake of calcium and vitamin D supplements during therapy (may reduce chelation efficacy). Maintain adequate hydration with water. No specific food restrictions, but a balanced diet is recommended to prevent deficiencies of essential minerals (zinc, copper) that may be chelated. |
| Clinical Pearls | Administer deep IM or slow IV infusion (over 2-4 hours) to avoid thrombophlebitis. Monitor urine output and renal function; nephrotoxicity is dose-dependent. Discontinue if oliguria or rising creatinine occurs. For lead encephalopathy, give concurrently with BAL (dimercaprol) to redistribute lead from CNS to blood. Use with caution in patients with pre-existing renal disease, hepatitis, or history of allergic reactions. EDTA can chelate essential metals (zinc, copper) leading to deficiencies during prolonged therapy. |
| Patient Advice | Report any signs of allergic reaction (rash, itching, difficulty breathing) or injection site pain/swelling immediately. · Drink plenty of fluids (unless instructed otherwise) to help flush out lead through urine. · Avoid taking any other medications, supplements, or over-the-counter products without consulting your doctor, as they may affect treatment. · Do not miss scheduled blood and urine tests; they are essential to monitor lead levels and kidney function. · Severe lead poisoning may cause fatigue, headache, abdominal pain; report these symptoms if they worsen. |
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