Edetate Calcium Disodium, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat lead poisoning.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. High doses of this medicine can cause kidney damage. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: chelating agent; antidote for lead poisoning

Generic and brand names: edetate calcium disodium, injection; Calcium Disodium Versenate; Calcium EDTA

What is this medicine used for?

This medicine is given by injection into a muscle or IV infusion (slow drip through a needle into a large vein) to treat lead poisoning. It will not prevent lead poisoning.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease
• Trouble urinating

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

This medicine is given by a healthcare provider. It is injected into a muscle or into a vein. It should only be given in a clinic or hospital where you can be monitored closely.

What should I watch out for?

This medicine may worsen the symptoms of lead poisoning, including brain swelling. Talk with your healthcare provider if you have a severe headache, neck pain, dizziness, or sudden trouble with vision, speech, balance, or walking. Make sure you understand what the risks and benefits of treatment are.

High doses of this medicine can cause kidney damage. If you are unable to urinate (no urine output) for a period of 12 hours after you receive a shot of this medicine, or if you see blood in your urine, contact your healthcare provider immediately.

You will need to have lab tests regularly to see how this medicine affects you. You may need to stop taking this medicine for a while depending on the results of these tests. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert. Watch small children who are taking this medicine to help prevent falls and injuries.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Bloody or cloudy urine; painful urination; urgent need to pass urine, especially at night; no urine output for 12 hours; fever; severe headache; increased thirst; irregular heartbeat; joint or muscle pain; blood in the urine; severe nausea or vomiting; itching; rash; swollen and cracked lips; tingling, numbness or pain in the hands or feet; blue skin color; unexplained tiredness or weakness; tremors.

Other: Metallic taste in the mouth, drowsiness, dizziness, headache, loss of appetite, sneezing, stuffy nose, nausea, vomiting, pain at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Insulin
• Zinc supplements

Do not have other treatment for lead poisoning such as chelation therapy with succimer, or penicillamine while you are receiving this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.