PHYSICIANS DESK REFERENCE 1964
Pp1203-4

CALCIUM DISODIUM VERSENATE®
(calcium disodium edetate)
Tablets

WARNING:
Calcium Disodium Edetate is capable of producing toxic and potentially fatal effects. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded.

Calcium Disodium Versenate (Calcium Disodium Edetate) Tablets contain 500mg. Of calcium disodium edetate per tablet.

Actions: Calcium in calcium disodium edetate is readily displaced by heavy metals, such as lead, to form stable complexes. The drug is poorly absorbed by the gastrointestinal tract. About 5 to 10% of oral calcium disodium edetate is absorbed in man. Orally administered calcium disodium edetate may enhance the absorption of lead and promote its excretion in the urine. Oral Versenate appears less effective in promoting the excretion of nonionized organic lead compounds, such as tetra-ethyl lead, than it is in promoting the excretion of ionized inorganic lead compounds. With the increased excretion of lead in urine there is a concomitant decrease in blood lead levels and in urine coproporphyrin.

Indications: To increase the excretion of lead.

Contraindications: Calcium Disodium Versenate Tablets should not be given to patients with severe renal disease.

Warnings: See box above.
Chronic oral use of Versenate should not be used as a substitute for adequate measures to avoid undue exposure to lead. Because Versenate chelates other metals, e.g. zinc, copper, etc., the possibility of depletion of such metals in persons taking Versenate on a long-term basis should be considered, and steps taken to avoid such deficiencies. Although urinary excretion of lead usually does increase following administration of Versenate, there is the possibility that, in come cases, a concomitant decrease in fecal excretion occurs. If this were to happen, the total amount of lead excreted might appear greater than is actually the case.

Usage in Pregnancy: The safe use of calcium disodium edetate has not been established with respect to possible adverse effects upon fetal development. Therefore, it should not be used in women of child-bearing potential and particularly during early pregnancy unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Precautions: The drug should be used with caution in tuberculosis, active or healed, and in the presence of renal disease.
There have been reports of increased absorption of lead from the gut following the use of oral Versenate.

Adverse Reactions: Calcium Disodium Versenate when administered orally may act as a gastrointestinal irritant in some patients, producing diarrhea, abdominal cramps, and vomiting. Such symptoms are more likely to occur when the daily dose exceeds 3gms. Other side actions reported in a relatively small percentage of patients were leg and other muscle cramps, weakness, malaise, and albumin or red cells in the urine. None of the side actions is considered to be serious when detected early. Excessive doses may result in renal toxicity.

Dosage and Administration: Adults: The average daily dosage is 8 tablets (4gm.) in divided doses.
Children: Two tablets (1gm.) daily per 35 pounds of body weight in divided doses.

How Supplied: Calcium Disodium Versenate Tablets, bottles of 250 tablets containing 500 mg. Of calcium disodium edetate per tablet. (NDC 009—0115-25)

===============================================================================
®Registered trademark of the Dow Chemical Company.