Edetate Calcium Disodium (Calcium EDTA, or sodium calcium edetate) is a chelating agent that is used for the short-term and long-term management of patients with acute and chronic lead poisoning.

Indications of Edetate Calcium Disodium (Calcium EDTA):

• It is indicated for the treatment of acute and chronic lead poisoning.

Edetate calcium disodium dose in Adults

Edetate calcium disodium dose in adults for the treatment of Lead poisoning:

If someone has lead poisoning and needs treatment with Edetate Calcium Disodium, the dosage depends on the severity of the poisoning.

• For blood lead levels below 70 mcg/dL and no symptoms:
  • Injection into muscle (IM) or intravenous (IV): 1000 mg per square meter of body surface area per day for 5 days.
• For blood lead levels of 70 mcg/dL or higher, or if there are symptoms (used together with another medication called dimercaprol):
  • IM or IV: 1000 mg per square meter of body surface area per day or 25 to 50 mg per kilogram of body weight per day for 5 days. The maximum suggested dose is 3000 mg.
• For lead encephalopathy (used together with dimercaprol):
  • IM or IV: 1500 mg per square meter of body surface area per day or 50 to 75 mg per kilogram of body weight per day for 5 days. The maximum suggested dose is 3000 mg.
• For lead nephropathy (kidney damage due to lead, and the dosage depends on the level of serum creatinine):
  • If serum creatinine is 2 to 3 mg/dL: 500 mg per square meter every 24 hours for 5 days.
  • If serum creatinine is 3 to 4 mg/dL: 500 mg per square meter every 48 hours for 3 doses.
  • If serum creatinine is greater than 4 mg/dL: 500 mg per square meter once weekly.

These doses may need to be repeated depending on the blood lead levels, and there should be a break of at least 2 to 4 days before starting another course of treatment.

Edetate calcium disodium dose in Childrens

Edetate Calcium Disodium (Calcium EDTA) Dose in the treatment of Lead poisoning:

For infants, children, and adolescents being treated for lead poisoning with Edetate Calcium Disodium, the dosage varies based on their blood lead levels and whether they are symptomatic. Here are the recommended doses:

• Blood lead levels below 70 mcg/dL and asymptomatic:
  • Injection into muscle (IM) or intravenous (IV): 1000 mg per square meter of body surface area per day for 5 days or 50 mg per kilogram of body weight per day for 5 days.
  • The suggested maximum daily dose is 1,000 mg/day in children.
• Blood lead levels of 70 mcg/dL or higher, or if symptomatic (used together with dimercaprol):
  • IM or IV: 1000 mg per square meter of body surface area per day or 25 to 50 mg per kilogram of body weight per day for 5 days.
  • The suggested maximum daily dose is 1,000 mg/day in children or 2,000 to 3,000 mg/day in adults.
• For lead encephalopathy (used together with dimercaprol):
  • IM or IV: 1500 mg per square meter of body surface area per day or 50 to 75 mg per kilogram of body weight per day for 5 days.
  • The suggested maximum daily dose is 1,000 mg/day in children or 2,000 to 3,000 mg/day in adults.

It's important to note that these recommendations may vary, and the dosages are based on the guidance from the American Academy of Pediatrics (AAP) and other sources. The treatment may require additional courses, with at least 2 to 4 days between repeat treatments.

Pregnancy Risk Factor B

• It's not well known how Edetate Calcium Disodium affects pregnant women because there haven't been enough studies.
• However, animal studies showed some problems during pregnancy.
• Lead, which this medicine helps remove, can pass from the mother to the baby and may lead to issues like miscarriage, premature birth, low birth weight, and problems with the baby's brain development.
• Even if a pregnant woman has low lead levels, some problems can still happen.
• If a pregnant woman has confirmed high blood lead levels (≥45 mcg/dL), doctors might consider using Edetate Calcium Disodium, especially if the levels are very high (≥70 mcg/dL).
• But it's crucial to talk to experts in lead poisoning and high-risk pregnancy, and there may be other treatments to consider.
• If a pregnant woman has lead poisoning that affects the brain, doctors might recommend treatment no matter the trimester.

Edetate calcium disodium use during breastfeeding:

• Edetate Calcium Disodium isn't absorbed well when taken by mouth (less than 5% gets into the body), so it's not used as an oral medicine, especially because it could increase the absorption of lead from the stomach and intestines.
• For nursing moms, the small amount of Edetate Calcium Disodium that does get into the body has minimal impact on breast milk, making it less likely to affect the baby.
• However, because lead levels in breast milk can be linked to the mother's blood lead levels, women with confirmed high blood lead levels (≥40 mcg/dL) shouldn't start breastfeeding.
• Instead, they should pump and discard breast milk until their blood lead levels drop below 40 mcg/dL, at which point they can safely resume breastfeeding.
• Taking calcium supplements might help reduce the amount of lead in breast milk.

Edetate Calcium Disodium (Calcium EDTA) Dose in Kidney Disease:

• If someone has mild preexisting kidney disease, the dose of Edetate Calcium Disodium should be reduced.
• It's recommended to limit the daily dose to 2 grams in adults to decrease the risk of kidney toxicity (nephrotoxicity).
• However, in certain situations, such as when treating lead encephalopathy (a condition where lead affects the brain), larger doses may be necessary.

Dose in Liver disease:

• It's important to note that if the manufacturer's labeling for Edetate Calcium Disodium does not provide specific dosage adjustments.

Edetate Calcium Disodium (Calcium EDTA):

• Cardiovascular:
  • Cardiac Arrhythmia
  • ECG Changes
  • Hypotension
  • Local Thrombophlebitis (IV Infusion When Concentration >5 Mg/Ml)
• Central Nervous System:
  • Chills
  • Fatigue
  • Headache
  • Malaise
  • Numbness
  • Paresthesia
• Dermatologic:
  • Cheilosis
  • Dermatitis
  • Skin Rash
• Endocrine & Metabolic:
  • Glycosuria
  • Hypercalcemia
  • Hypokalemia
  • Iron Deficiency (With Chronic Therapy)
  • Magnesium Deficiency (With Chronic Therapy)
  • Polydipsia
  • Zinc Deficiency (With Chronic Therapy)
• Gastrointestinal:
  • Anorexia
  • Gastrointestinal Irritation
  • Nausea
  • Vomiting
• Genitourinary:
  • Nephrosis
  • Nephrotoxicity
  • Occult Blood In Urine
  • Proteinuria
  • Urinary Frequency
  • Urinary Urgency
• Hematologic & Oncologic:
  • Anemia
  • Bone Marrow Depression (Transient)
• Hepatic:
  • Decreased Serum Alkaline Phosphatase
  • Increased Liver Enzymes (Mild)
• Local:
  • Pain At Injection Site (Intramuscular)
• Neuromuscular & Skeletal:
  • Arthralgia
  • Myalgia
  • Tremor
• Ophthalmic:
  • Lacrimation
• Renal:
  • Renal Tubular Necrosis
• Respiratory:
  • Nasal Congestion
  • Sneezing
• Miscellaneous:
  • Fever

Contraindications to Edetate Calcium Disodium (Calcium EDTA):

• Edetate Calcium Disodium may not be suitable for individuals with active renal disease (ongoing kidney problems) or anuria (lack of urine production).
• Additionally, individuals with hepatitis (inflammation of the liver) may need to exercise caution or avoid the use of Edetate Calcium Disodium.
• These conditions can affect how the body processes and eliminates medications, potentially leading to complications.

Warnings and precautions

Arrhythmias:

• Keep an eye out for irregular heartbeats (arrhythmias) and changes in the heart's electrical activity (ECG) when using Edetate Calcium Disodium through intravenous (IV) therapy.

Nephrotoxicity:

• Edetate Calcium Disodium has the potential to be harmful to the kidneys (nephrotoxic).
• Using high doses, especially more than what is recommended for a day, may lead to serious kidney problems like renal tubular acidosis and fatal nephrosis.
• If there are signs like no urine production (anuria), increasing protein in the urine, or blood in the urine (hematuria) during the treatment, it's crucial to stop using the medication.
• To reduce the risk of kidney issues, it's important to ensure good hydration, maintain a healthy urine flow, avoid excessive doses, and limit continuous use to no more than 5 days.
• These precautions help in minimizing the chances of kidney problems associated with the use of Edetate Calcium Disodium.

Cerebral edema [US Boxed Warning]

• There's a serious warning for Edetate Calcium Disodium use in patients with lead encephalopathy and cerebral edema (swelling in the brain).
• Extreme caution is advised because using this medication through intravenous (IV) infusion in these patients has been linked to a dangerous increase in pressure inside the skull, which can be fatal.
• In such cases, it's preferred to use intramuscular (IM) injection instead of IV infusion to minimize the risk associated with increased intracranial pressure.

Lead poisoning:

• Before starting treatment for lead poisoning, it's important to thoroughly investigate, identify, and eliminate the sources of lead exposure.
• Primary care providers should seek guidance from experts familiar with treating lead toxicity before considering chelation drug therapy.
• Patients should not be allowed to return to an environment with lead contamination until lead abatement (removing or reducing the lead source) has been completed.
• This approach is essential for addressing the root cause of lead poisoning and ensuring the effectiveness of the treatment.

Renal impairment

• Exercise caution when using Edetate Calcium Disodium in patients with renal impairment (kidney problems).
• It's advisable to use a reduced dose in these individuals to prevent any potential adverse effects related to the kidneys.
• Adjusting the dosage based on the extent of renal impairment helps ensure the medication is used safely and effectively.

Edetate calcium disodium (calcium EDTA): Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Urinary Output:
  • Regularly check how much urine is being produced.
• Urinalysis:
  • Examine urine for any abnormalities.
• Renal Function:
  • Assess the overall function of the kidneys.
• Hepatic Function:
  • Evaluate the functioning of the liver.
• Serum Electrolytes:
  • Check the levels of essential minerals in the blood.
  • Baseline measurement and daily monitoring in severe lead poisoning.
  • Monitoring at days 2 and 5 in less severe lead poisoning.
• ECG (Electrocardiogram):
  • Perform ECG during intravenous therapy to monitor heart activity.
• Blood Lead Levels:
  • Measure lead levels in the blood.
  • Initial measurement before starting treatment.
  • Follow-up measurement 7-21 days after completing chelation therapy.
• Hemoglobin or Hematocrit:
  • Assess blood for indicators of anemia.
• Iron Status:
  • Check the levels of iron in the blood.
• Free Erythrocyte Protoporphyrin or Zinc Protoporphyrin:
  • Measure these substances related to lead exposure.
• Neurodevelopmental Changes:
  • Monitor for any changes in neurodevelopmental status.

Regular monitoring of these factors is crucial to ensure the safe and effective use of Edetate Calcium Disodium, especially in the treatment of lead poisoning.

How to administer Edetate Calcium Disodium (Calcium EDTA)?

For IM or IV Use:

• IV Infusion:
  • Preferred route, except when cerebral edema is present.
  • Administer the daily dose as a diluted solution over 8 to 12 hours or continuously over 24 hours.
  • Helps in a slow and controlled delivery of the medication.
• IM Injection:
  • Use when cerebral edema is present.
  • Divide the daily dose into 2 to 3 equal doses spaced 8 to 12 hours apart.
  • Procaine hydrochloride or lidocaine may be added to reduce pain at the injection site.
  • Administer via deep IM injection for effective absorption.
  • When used with dimercaprol, inject into a separate site.

Choosing between IV infusion and IM injection depends on factors such as the patient's condition and the presence of cerebral edema.

Mechanism of action of Edetate Calcium Disodium (Calcium EDTA):

• When divalent and trivalent heavy metals are in the body, calcium can be pushed aside.
• This leads to the creation of a soluble complex with lead, which doesn't have an electric charge and can dissolve in urine.
• This complex is then removed from the body through urine, helping to get rid of lead.

Chelation of Lead:

• Onset of Action (IV): Begins working in about 1 hour after intravenous administration.
• Maximum Excretion (IV): Leads to the highest removal of chelated lead within 24 to 48 hours after intravenous administration.

How the Body Processes Edetate Calcium Disodium:

• Absorption:
  • IM, SubQ: Well absorbed when injected into the muscle or under the skin.
  • Oral: Poor absorption, less than 5% is taken in when swallowed.
• Distribution:
  • Moves into the fluid outside cells (extracellular fluid).
  • Penetrates the cerebrospinal fluid (CSF) minimally, around 5%.
• Metabolism:
  • Almost no changes happen to the drug in the body; it remains mostly the same.
• Elimination:
  • Half-life: The time it takes for half of the drug to leave the body is between 20 to 60 minutes.
  • Excretion: Leaves the body through urine either as metal chelates or unchanged drug.
  • Decreased kidney function (GFR) slows down the elimination process.

International Brand Names of Edetate calcium disodium:

• Calcium Edetate de Sodium
• Edetal-CA
• Kedato

Edetate calcium disodium Brand Names in Pakistan:

Not available.