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Ca-Dtpa (Pentetate Calcium Trisodium) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Ca-DTPA to evaluate carcinogenesis, mutagenesis, and impairment of fertility have not been performed. Data for Ca-DTPA effects on spermatogenesis are not available.

Teratogenic Effects

Pregnancy Category C

There are no human pregnancy outcome data from which to assess the risk of Ca-DTPA exposure on fetal development. Ca-DTPA is believed to be teratogenic based on animal data and because chelation therapy results in the depletion of body stores of zinc which is known to affect DNA and RNA synthesis in humans. There are no animal or human data evaluating the teratogenic effect of the administration of a single dose of Ca-DTPA. Based on its mechanism of action, the likelihood that a single dose or multiple doses of Ca-DTPA is teratogenic in humans cannot be ruled out. In mice, Ca-DTPA has been shown to be teratogenic and embryocidal following five daily injections of 720-2880 µmol Ca-DTPA/kg [2- 8 times the recommended daily human dose of 1 gram based on body surface area (BSA) adjusted dose] given during any period of gestation. The frequency of gross malformations (e.g., exencephaly, spina bifida, and cleft palate) increased with dose, with higher susceptibility in early and mid gestation. Five daily doses of 360 µmol Ca-DTPA/kg in mice, approximately equivalent to the recommended daily human dose (based on BSA) produced no harmful effects. Studies of 2 pregnant dogs given daily injections of 30 µmol Ca-DTPA/kg (approximately half the recommended daily human dose based on BSA) from implantation until parturition showed severe teratogenic effects (especially brain damage).

Multiple doses of Ca-DTPA could result in an increased risk for adverse reproductive outcomes and thus are not recommended during pregnancy. Therefore, treatment of pregnant women should begin and continue with Zn-DTPA, if available, except in cases of high internal radioactive contamination. In these cases, the risk of immediate and delayed radiation-induced toxicity to both the mother and the fetus should be considered in comparison to the risk of Ca-DTPA toxicity. Also, because Ca-DTPA is more effective than Zn-DTPA in the first 24 hours after internal contamination, it may be appropriate to use a single dose of Ca-DTPA with vitamin or mineral supplements that contain zinc as the initial treatment.

OVERDOSAGE

In previous clinical studies, three deaths were reported in patients with severe hemochromatosis who were treated with daily IM Ca-DTPA dosed up to 4 gram per day to reduce iron stores. One patient became comatose and died after receiving a total of 14 gram Ca-DTPA, and the other two died after two weeks of daily treatment. Causal association with these events and the drug has not been established. (See WARNINGS)

CONTRAINDICATIONS

None known.

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