Edetate calcium disodium

What is Edetate calcium disodium?

• Edetate calcium disodium (Calcium disodium versenate) is a sterile, injectable, chelating agent used to treat lead poisoning, including both short-term and long-term lead poisoning.

Sodium calcium edetate

What are the uses of this medicine?

• Edetate calcium disodium (Calcium disodium versenate) is used 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.

How does this medicine work?

• The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals.
• A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• periods of anuria
• active renal disease or hepatitis

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• Steroids
• zinc
• insulin

Is this medicine FDA approved?

• Sodium calcium edetate came into medical use in the United States in 1953.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• It is given by slow injection into a vein or into a muscle.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As concentrated solution for intravenous infusion or intramuscular injection.
• Each 5 ml ampule contains 1000 mg of edetate calcium disodium (equivalent to 200 mg/ml) in water for injection.

This medicine is available in fallowing brand namesː

• Calcium disodium versenate

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia

Less common side effects may include: Cardiovascular: hypotension, cardiac rhythm irregularities. Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.

• Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.
• Nervous System: tremors, headache, numbness, tingling.
• Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.
• Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.
• Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.
• Hematopoietic: transient bone marrow depression, anemia.
• Metabolic: zinc deficiency, hypercalcemia.

What special precautions should I follow?

• Calcium Disodium Versenate is capable of producing toxic effects which can be fatal.
• Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high.
• Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded.
• Edetate calcium disodium may produce the same renal damage as lead poisoning, such as proteinuria and microscopic hematuria. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Patients should be monitored for cardiac rhythm irregularities and other ECG changes during intravenous therapy.
• Patients should be instructed to immediately inform their physician if urine output stops for a period of 12 hours.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Disodium Versenate is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• cerebral edema, renal tubular necrosis
• severe zinc deficiency

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Cerebral edema should be treated with repeated doses of mannitol.
• Steroids enhance the renal toxicity of edetate calcium disodium in animals and, therefore, are no longer recommended.
• Zinc levels must be monitored.
• Good urinary output must be maintained because diuresis will enhance drug elimination.
• It is not known if edetate calcium disodium is dialyzable.

Can this medicine be used in pregnancy?

• Category B.
• Here are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
• Calcium Disodium Versenate has no recognized use during labor and delivery, and its effects during these processes are unknown.

Can this medicine be used in children?

• Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, Calcium Disodium Versenate is used in patients of all ages.
• The intramuscular route is preferred by some for young pediatric patients.
• In cases where the intravenous route is necessary, avoid rapid infusion.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• EDETATE CALCIUM DISODIUM

Inactive ingredients:

• WATER

Who manufactures and distributes this medicine?

Manufactured for:

• Medicis, The Dermatology Company
• Scottsdale, AZ

By:

• CP Pharmaceuticals, Ltd.
• Wrexham LL13 9UF, U.K.
• Product of UK

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Edetate calcium disodium
• FDA Edetate calcium disodium

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