Pentetate Calcium Trisodium Interactions

Brand names: Pentetate Calcium Trisodium

Route: Intravenous, Respiratory (Inhalation)

FDA Black Box Warning

WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY Nebulized Ca-DTPA may be associated with asthma exacerbation. ( 5.1 ) Ca-DTPA is associated with depletion of trace metals such as zinc. The magnitude of depletion increases with split daily dosing, with increasing dose and with increased treatment duration. Only a single dose of Ca-DTPA is recommended. Use Zn-DTPA if additional chelation therapy is indicated. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 ) WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY See full prescribing information for complete boxed warning. Nebulized Ca-DTPA may be associated with asthma exacerbation. ( 5.1 ) Ca-DTPA is associated with depletion of trace metals such as zinc. The magnitude of depletion increases with split daily dosing, with increasing dose and with increased treatment duration. Only a single dose of Ca-DTPA is recommended. Use Zn-DTPA if additional chelation therapy is indicated. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 )

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled studies of Ca-DTPA use in pregnant women. Ca-DTPA chelation therapy causes depletion of body stores of zinc, a trace metal essential for fetal development [see Warnings and Precautions (5.2) ] . The consequences of zinc depletion and results of animal studies suggest a teratogenic risk in humans. Ca-DTPA was teratogenic and embryotoxic in mice at daily doses 2 to 8 times the recommended daily human dose, based on body surface area (BSA), with a dose-dependent increase in the frequency of gross malformations. Ca-DTPA was teratogenic in dogs at approximately half the recommended daily human dose based on BSA, as described below. There are no animal or human data evaluating the teratogenic effect of a single dose of Ca-DTPA. Ca-DTPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Chelation treatment of pregnant women should begin and continue with Zn-DTPA, if available, except in cases of high internal radioactive contamination. 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. Animal Data Ca-DTPA is teratogenic and embryotoxic in mice during any period of gestation following five daily subcutaneous injections of 720 to 2880 micromol Ca-DTPA/kg [2 to 8 times the recommended daily human dose of 1 gram based on BSA]. The frequency of gross malformations (e.g., exencephaly, spina bifida, cleft palate, ablepharia, and polydactyly) and fetal mortality increased with dose, with higher susceptibility in early and mid gestation. Five daily doses of 360 micromol Ca-DTPA/kg in mice, approximately equivalent to the recommended daily human dose (based on BSA) produced no harmful effects. A study of two pregnant dogs given daily intra

2 interactions on record